Blinded me with Science

Evaluation of the effects of hyaluronic acid-carboxymethyl cellulose barrier on ovarian tumor progression

PRESS RELEASE
Hyaluronic acid is a prognostic factor in ovarian cancers. It is also a component of Hyaluronic Acid-Carboxymethyl Cellulose (HA-CMC) barrier, an anti-adhesion membrane widely used during abdominal surgeries in particular for ovarian carcinosis.

70% of patients who undergo ovarian surgery will relapse due to the persistence of cancer cells. This study's objective was to determine the oncological risk from use of this material, in the presence of residual disease, despite the benefit gained by it decreasing post-surgical adhesions in order to provide an unambiguous assessment of its appropriateness for use in ovarian surgical management. 

Methods: We assessed the effects of HA-CMC barrier on the in vitro proliferation of human ovarian tumor cell lines (OVCAR-3, IGROV-1 and SKOV-3).

We next evaluated, in vivo in nude mice, the capacity of this biomaterial to regulate the tumor progression of subcutaneous and intraperitoneal models of ovarian tumor xenografts. 

Results: We showed that HA-CMC barrier does not increase in vitro proliferation of ovarian cancer cell lines compared to control. In vivo, HA-CMC barrier presence with subcutaneous xenografts induced neither an increase in tumor volume nor cell proliferation (Ki67 and mitotic index).

With the exception of an increased murine carcinosis score in peritoneum, the presence of HA-CMC barrier with intraperitoneal xenografts modified neither macro nor microscopic tumor growth. Finally, protein analysis of survival (Akt), proliferation (ERK) and adhesion (FAK) pathways highlighted no activation on the xenografts imputable to HA-CMC barrier. 

Conclusions: For the most part, our results support the lack of tumor progression activation due to HA-CMC barrier.

We conclude that the benefits gained from using HA-CMC barrier membrane during ovarian cancer surgeries seem to outweigh the potential oncological risks.

Author: Laetitia PicaudBenoît ThibaultEliane MeryMonia OualiAlejandra MartinezJean-Pierre DelordBettina CoudercGwenael Ferron
Credits/Source: Journal of Ovarian Research 2014, 7:40

http://7thspace.com/headlines/457665/evaluation_of_the_effects_of_hyaluronic_acid_carboxymethyl_cellulose_barrier_on_ovarian_tumor_progression.html

Adhesiolysis in Germany Dr. Matthias Korell and Dr. Jens Pagel

Adhesiolysis in Germany Dr. Matthias Korell and Dr. Jens Pagel

Dr. Matthias Korell
Johanna-Etienne Hospital Neuss

On Hasenbergstraße 46 
41462 Neuss 
North Rhine-Westphalia
Germany

Phone : 02131/5295-5002 
Fax: 02131/5295-5003 

PD Dr. Matthias Korell practiced as:

• Specialist in Obstetrics u.Geburtshilfe
• PD Dr. Matthias Korell speaks: German.Vocational group is senior consultant or senior doctor. 
• ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

 Dr. Jens Pagel

St. Joseph's Hospital Department of Obstetrics and Gynecology

Asberger Strasse 4 
47441 Moers 
North Rhine-Westphalia
Germany

Phone : 02841/107-2430 
Fax: 02841/107-2000 

Dr. Jens Pagels practiced as:

• Specialist in Obstetrics u.Geburtshilfe
• Dr. Jens Pagels speaks: German. Vocational group is senior consultant or senior doctor. 

Preliminary study with SprayShield™ Adhesion Barrier System in the prevention of abdominal adhesions

Preliminary study with SprayShield™ Adhesion Barrier System in the prevention of abdominal adhesions

Wideochir Inne Tech Malo Inwazyjne. Dec 2013; 8(4): 301–309.

Published online May 6, 2013. doi:  10.5114/wiitm.2011.34884

 

PMCID: PMC3908634

Tomasz Banasiewicz,1 Karolina Horbacka,2 Jacek Karoń,2 Stanisław Malinger,1 Frantisek Antos,3 Sławomir Rudzki,4Zdenek Kala,5 Zoran Stojcev,6 Jyrki Kössi,7 and Piotr Krokowicz2

Author information ► Article notes ► Copyright and License information ►

Copyright © 2013 Sekcja Wideochirurgii TChP

This is an Open Access article distributed under the terms of the Creative Commons Attribution-Noncommercial 3.0 Unported License, permitting all non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

ABSTRACT

Introduction

Peritoneal adhesions, the fibrotic bands that form between the surfaces in the peritoneal cavity following surgery, still pose a difficult clinical challenge.

Aim

To evaluate the SprayShield™ Adhesion Barrier System (PEG ester amine solution and a buffer solution) in reducing post-operative adhesion formation.

Material and methods

This was a prospective, multi-center, randomized, single blind study. A total of 11 subjects diagnosed with ulcerative colitis (UC) or familial adenomatous polyposis (FAP) were randomized: 8 to the SprayShield™ arm and 3 to the control arm. SprayShield™ was applied on the viscera directly under the midline peritoneal incision and at the site of ileostomy. During the follow-up surgery, the incidence, extent, and severity of post-operative adhesion formation were evaluated, as well as the time required to mobilize the ileal loop.

Results

In patients who received SprayShield™ the time required to mobilize the ileal loop at the ileostomy closure was slightly shorter and the incidence and severity of adhesions were somewhat lower vs. control subjects (NS).

Conclusions

SprayShield™ was found to be easy to use, safe, and quick to apply, and performed well in adherence and conformity. The incidence and severity of adhesions were lower for SprayShield™ subjects vs. control subjects, but due to the limited number of patients there are not enough data to confirm the effectiveness of the SprayShield™ Adhesion Barrier System in prevention of adhesions.

Keywords: adhesions, adhesion prevention, laparotomy, ileostomy

Integra Buys Covidien’s Confluent Surgical Product Lines

By HospiMedica International staff writers Posted on 18 Nov 2013

Integra LifeSciences (Plainsboro Township, NJ, USA) is to acquire the Covidien (Dublin, Ireland) Confluent Surgical product line, including surgical sealants, adhesion barrier, and, most significantly, DuraSeal.

The DuraSeal system technology is a synthetic, absorbable, hydrogel delivered by a dual syringe applicator. When sprayed onto the dura, a strong, adherent sealing layer is produced, which effectively seals the suture line within seconds. A feature unique to DuraSeal is the blue colorant that provides the surgeon excellent visualization of coverage and thickness of the material upon application. The addition of a dural sealant technology to Integra’s current line enables the surgeon to adopt a “one stop shop” approach to closing the Dura Mater following neurosurgical procedures, complementing the company’s dural substitute, Duragen.

The other products in the Confluent Surgical product line include DuraSeal Exact/Xact, VascuSeal, and SprayShield. The products are part of the soft tissue repair category at Covidien, and generated approximately USD 65 million in sales in fiscal 2012. Under the terms of the agreement, Covidien will receive an initial cash payment of USD 235 million from Integra. Additionally, Covidien may receive up to USD 30 million, contingent upon the achievement of certain performance measures related to the transition of the Confluent Surgical business to Integra.

“The addition of the DuraSeal product lines enables our sales force and distributor partners to provide their customers with a best-in-class dural sealant as they seek to support surgeon’s efforts to minimize cerebrospinal fluid leaks upon completion of the surgical procedure,” said Robert Davis, President of Integra’s US Neurosurgery division. “Together with our broad DuraGen product line we are fortunate to have even more options to serve our customers and the individual needs of their patients.”

“This transaction allows Covidien to better focus on its global strategic priorities,” said Bryan Hanson, group president of medical devices & US at Covidien. “Based on Integra’s presence in neurosurgery and spine surgery combined with a strong portfolio of clinical evidence, we believe these products will thrive under Integra’s ownership. We express our sincere gratitude to our dedicated employees and the clinicians who have partnered with us throughout the years.”

Related Links:
Integra LifeSciences
Covidien

Huge Ethics Breech Dr Daniel Kruschinski of Germany Marries Surgical Patient after 20 Surgeries in One Month

This is about the most egregious breech of ethics a doctor can commit.
He brags of it on his website and sees nothing wrong with this. He claims in public her poor frantic family is jealous of him!  
She is at least 20 tears his junior. Repulsive!
Take a look.

ADHESIOLYSIS #2

Some of the cases with “Frozen abdomen” are so severe that they present not only adhesions to the abdominal wall and between the bowel loops, but have all organs and bowel loops surrounded by a very dense connective tissue, glueing the organs together and causing constrictions of the bowel.

Those patients need a “Multi-Step-Adhesiolysis” according to the EndoGyn concept and are informed after the first procedure that we will work upon their symptoms in different abdominal quadrants by setting-up a multistep adhesiolysis according to their symptoms.

The first step always includes full adhesiolysis of the abdominal wall as these adhesions are often causing bowel obstructions. Also a partial interluminal adhesiolysis of the bowel loop adhesions is included in the first step.

So in January 2010 the patient was admitted again and we performed the 3rd look procedure on January 18th, 2010, followed by 7 other laparoscopic procedures due to an infection and to avoid reformation of adhesions.

We had to keep the patient for 31 days in the hospital and she had all together 8 surgeries performed.

- 18/01/2010: Gasless Lift-Laparoscopy as 3rd look

– 20/01/2010: 4th look
- 25/01/2010: 5th look
- 27/01/2010: 6th look
- 29/01/2010: 7th look
- 01/02/2010: 8th look
- 05/02/2010: 9th look
- 09/01/2010: 10th look

Please check the text under the images!

PLEASE SCROLL DOWN!

http://laparoscopyofadhesiolysis.com/adhesiolysis-worst-cases-case-1-adhesiolysis-1

If you have a strong stomach, see her surgical photos where it appears he is combining 2 different adhesion barriers or using adept only even though everyone thinks they are getting sprayygel.

This poor woman is lucky to be alive. (IHRT opines her suffering has just begun.)

Here is some insight as to a proper patient and doctor relationship.

Opinion 8.14 - Sexual Misconduct in the Practice of Medicine

Sexual contact that occurs concurrent with the patient-physician relationship constitutes sexual misconduct. Sexual or romantic interactions between physicians and patients detract from the goals of the physician-patient relationship, may exploit the vulnerability of the patient, may obscure the physician’s objective judgment concerning the patient’s health care, and ultimately may be detrimental to the patient’s well-being.

If a physician has reason to believe that non-sexual contact with a patient may be perceived as or may lead to sexual contact, then he or she should avoid the non-sexual contact. At a minimum, a physician’s ethical duties include terminating the physician-patient relationship before initiating a dating, romantic, or sexual relationship with a patient.

Sexual or romantic relationships between a physician and a former patient may be unduly influenced by the previous physician-patient relationship. Sexual or romantic relationships with former patients are unethical if the physician uses or exploits trust, knowledge, emotions, or influence derived from the previous professional relationship. (I, II, IV)

Issued December 1989; Updated March 1992 based on the report "Sexual Misconduct in the Practice of Medicine," adopted December 1990 (JAMA. 1991;266:2741-2745).

Maryland follows New Jersey in Seprafilm Suit

AG Gansler: Genzyme Corp. Pays $22.28 Million for Fraudulent Marketing of ' Slurry' Improperly Used in Surgery Maryland Medicaid to receive $85,000 from Seprafilm allegations

AG Gansler: Genzyme Corp. Pays 22.28 Million for Fraudulent Marketing of ' Slurry' Improperly Used in Surgery Maryland Medicaid to receive 85,000 from Seprafilm allegations

Mar 10, 2014 (Menafn - M2 PRESSWIRE via COMTEX) --Attorney General Douglas F. Gansler announced today that Maryland, joined by other states and the federal government, has secured a settlement resolving allegations that Genzyme Corporation triggered false claims to be submitted to federal and state health care programs for unapproved use of a "slurry" version of its Seprafilm adhesion barrier. Genzyme will pay 22.28 million under the settlement. Maryland Medicaid will receive 84,627.69, to be shared with the federal government, which provides funding for the program.

"Cutting corners shows little concern for the wellbeing of the people who used this product and for the general public whose tax dollars support the Medicaid program," said Attorney General Gansler. "The profit from the fraudulent sales of this product will be forfeited and returned to its intended use."

Seprafilm is intended to reduce post-surgical adhesions by forming a bio-resorbable (broken down and assimilated back into the body) barrier between abdominal tissue and organs. This Food and Drug Administration (FDA)-approved product is for use in open abdominal surgery, but not for minimally invasive procedures such as laparoscopic surgery.

The settlement resolves allegations that Genzyme sales representatives taught doctors and other staff to cut the Seprafilm sheets into small pieces, add saline and allow the pieces to dissolve until the desired consistency was reached. This mixture was referred to as "slurry." Genzyme sales representatives traded recipes for slurry and trained each other how to produce it. The slurry was used in laparoscopic surgeries by inserting a catheter filled with the mixture into the body and applying it into the abdominal cavity. As a result of this conduct, Genzyme knowingly caused hospitals and other purchasers of Seprafilm to submit false and fraudulent claims to federal health care programs for uses that were not FDA-approved and therefore, not reimbursable.

Genzyme is a biotechnology corporation based in Cambridge, Mass., and was acquired by Sanofi-Aventis SA in April 2011.

Attorney General Gansler thanked Medicaid Fraud Control Unit Deputy Director Shelly Marie Martin for her work on this case. A National Association of Medicaid Fraud Control Units (NAMFCU) team participated in the investigation and conducted settlement negotiations with Genzyme.

Attorney General of Maryland 1 (888) 743-0023 toll-free / TDD: (410) 576-6372

((M2 Communications disclaims all liability for information provided within M2 PressWIRE. Data supplied by named party/parties. Further information on M2 PressWIRE can be obtained at http://www.presswire.com on the world wide web. Inquiries to info@m2.com.

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Breaking News Seprafilm Genzyme

Attorney General J.B. Van Hollen Announces Settlement with Genzyme Corporation to Resolve Allegations of Off-Label Marketing

March 07, 2014

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Targeted News Service

MADISON, Wis., March 6 -- The WisconsinAttorney General issued the following news release:

Attorney General J.B. Van Hollen announced today that Wisconsin has joined with other states and the federal government to settle allegations thatGenzyme Corp. (Genzyme) marketed and caused false claims to be submitted to federal and state health care programs for use of a "slurry" version of its Seprafilm adhesion barrier. Seprafilm is a thin film intended to reduce adhesions after surgery by forming a bio-resorbable barrier between abdominal tissue and organs. Genzyme is a biotechnology corporation based in Cambridge, Mass., and was acquired by Sanofi-Aventis SA in April 2011. As part of the settlement, Wisconsin Medicaid will receive $44,698.27 in restitution and other recoveries. Medicaid is a health insurance program for the needy and disabled jointly funded by the state and federal governments. The agreement resolves allegations that Genzyme sales representatives taught doctors and other staff to cut the Seprafilm sheets into small pieces, add saline and allow the pieces to dissolve until the desired consistency was reached. This mixture was referred to as "slurry." Genzyme sales representatives traded recipes for slurry, and trained each other in how to create it. The slurry was used in laparoscopic surgeries by inserting a catheter filled with the mixture into the body and applying it into the abdominal cavity. Seprafilm isFDA-approved for use in open abdominal surgery but not for minimally invasive surgeries, such as laparoscopic surgery. Allegedly, as a result of this conduct,Genzyme knowingly caused hospitals and other purchasers of Seprafilm to submit false and fraudulent claims to health care programs for uses that were not reimbursable.

TNS 30FurigayJof 140307-4659904 30FurigayJof

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German Researchers Introduce Endo Gel Adhesion Barrier

German Researchers Introduce Endo Gel Adhesion Barrier

Perhaps this may help you make an informed decision in your struggles with Adhesion Related Disorder

BioScience GmbH
 BioScience was established in 2005 in Germany by a team of researchers and experts with over three decades of experience in the medical industry We serve our customers with a wide range of products for surgeons, physicians, and other health care professionals. BioScience is strongly committed to product excellence and is proud to be registered ISO 13485:2003 .

BioScience GmbH . Rheinstrabe 96. D-56235 Ransbach-Baumbach. Telephone:+49(0)2623 9709793 FAX:+49(0) 2623 9709792  info@bio-science.org

About Adhesion
In accordance to good surgical practice and preventing formation of post surgical adhesions it is recommended to use Hyacorp endo gel; which forms a physical barrier against the contact between adjacent tissues and remain on the site of application for seven days, which is sufficient to avoid the formation of adhesions during the critical healing process of injured tissues.
HYAcorp endo gel is a Bio-absorbable ,sterile , transparent, high viscous gel obtained by condensation of hyaluronic acid, one of the main components of human connective tissue and of epithelial and mesothelial tissues and it perfectly adheres to the tissue surface and to the abdominal wall creating an anti adhesion barrier.

Read More: http://www.hyacorp-endogel.com/index.html

The inpatient burden of abdominal and gynecological adhesiolysis in the US w Thanks to NIH

BMC Surg. 2011; 11: 13.

Published online 2011 June 9. doi:  10.1186/1471-2482-11-13

PMCID: PMC3141363

The inpatient burden of abdominal and gynecological adhesiolysis in the US

Vanja Sikirica,1 Bela Bapat,2 Sean D Candrilli,2 Keith L Davis,2 Malcolm Wilson,3 and Alan Johns4

Author information ► Article notes ► Copyright and License information ►

This article has been cited by other articles in PMC.

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Abstract

Background

Adhesions are fibrous bands of scar tissue, often a result of surgery, that form between internal organs and tissues, joining them together abnormally. Postoperative adhesions frequently occur following abdominal surgery, and are associated with a large economic burden. This study examines the inpatient burden of adhesiolysis in the United States (i.e., number and rate of events, cost, length of stay [LOS]).

Methods

Hospital discharge data for patients with primary and secondary adhesiolysis were analyzed using the 2005 Healthcare Cost and Utilization Project's Nationwide Inpatient Sample. Procedures were aggregated by body system.

Results

We identified 351,777 adhesiolysis-related hospitalizations: 23.2% for primary and 76.8% for secondary adhesiolysis. The average LOS was 7.8 days for primary adhesiolysis. We found that 967,332 days of care were attributed to adhesiolysis-related procedures, with inpatient expenditures totaling $2.3 billion ($1.4 billion for primary adhesiolysis; $926 million for secondary adhesiolysis). Hospitalizations for adhesiolysis increased steadily by age and were higher for women. Of secondary adhesiolysis procedures, 46.3% involved the female reproductive tract, resulting in 57,005 additional days of care and $220 million in attributable costs.

Conclusions

Adhesiolysis remain an important surgical problem in the United States. Hospitalization for this condition leads to high direct surgical costs, which should be of interest to providers and payers.

Keywords: Adhesions, adhesiolysis, abdominal, gynecological, burden of illness, hospitalizations

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Background

Adhesions are fibrous bands of scar tissue, often result of surgery, that form between internal organs and tissues, joining them together abnormally [1]. Postoperative adhesions frequently occur following abdominal surgery and are a leading cause of intestinal obstruction. It has been estimated that more than 90% of patients who undergo abdominal operations will develop postoperative adhesions [2].

The most severe complication of postoperative adhesions is small bowel obstruction (SBO), which has a 10% risk of mortality [3,4]. Recent research has demonstrated that readmission episodes averaged 2.7 per patient for SBO or nonspecific abdominal pain (when adhesions were considered likely). Inpatient readmissions accounted for 87% of episodes; 47% of those required repeat surgery [5]. Additionally, in the large retrospective study Surgical and Clinical Adhesions Research, surgical procedures performed on the bowel or the female reproductive system were associated with an increased chance of adhesion development, termed adhesiolysis [6-8]. Ray and colleagues found that 47% of adhesiolysis-related inpatient hospitalizations were for procedures involving the female reproductive tract [2]. Postoperative adhesiolysis-related SBO occurred in 2.8% of patients undergoing hysterectomy for benign conditions and in 5% of those undergoing radical hysterectomy [4,9].

A number of studies have shown that the economic burden of adhesiolysis is significant [2,5,10]. It was estimated that adhesiolysis procedures resulted in 303,836 hospitalizations, 846,415 days of inpatient care, and nearly $1.3 billion in health care expenditures in the United States (US) in 1994 [2]. This cost has decreased when compared with similar data from 1988,[10] due in part to laparoscopic surgery. Despite the decrease in costs associated with laparoscopic surgery, increased use of such techniques did not lead to a decreased rate of overall hospitalizations [2].

Utilizing more recent data, we estimated the current burden of inpatient treatment of adhesiolysis in the US. This study examined the number and rate of adhesiolysis-related hospitalizations, days of care attributable to adhesiolysis, and length of stay (LOS) for adhesiolysis-related hospitalizations, with primary and secondary procedures considered separately. Additionally, we assessed total inpatient costs attributable to adhesiolysis.

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Methods

Data Source

Data were taken from the 2005 Healthcare Cost and Utilization Project's (HCUP) Nationwide Inpatient Sample (NIS)[11]. The NIS is the largest all-payer inpatient care database in the US and contains data from approximately 8 million hospital stays in 2005. The database also contains clinical and resource use information, including patient demographics, International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) diagnosis and procedure codes, diagnosis-related group (DRG) codes, LOS, charges, discharge status, payer source, and hospital-specific characteristics. Using the survey design elements provided with the NIS, data can be weighted to produce nationally representative estimates [12]. All financial information in the NIS database is presented as charges rather than costs. To convert hospital charges to costs, facility-specific cost-to-charge ratios were used. Finally, the medical care component of the Consumer Price Index was applied to inflate all financial data to 2007 US dollars [13].

RTI International's Institutional Review Board determined that this study met all criteria for exemption.

Study Sample

From the NIS, all hospitalizations containing a DRG code of peritoneal adhesiolysis with or without complications (i.e., DRG 150, 151) were defined as primary adhesiolysis-related hospitalizations. Hospitalizations containing a primary or nonprimary ICD-9-CM procedure code for adhesiolysis, but without DRG 150 or 151, were defined as secondary adhesiolysis-related hospitalizations (Table ​(Table1).1). Hospitalizations related to secondary adhesiolysis were stratified by body system, using the following DRG coding:

Table 1

Description of Procedure (ICD-9-CM) Codes Used to Identify Adhesiolysis-Related Surgical Procedures

(1) Digestive system (i.e., DRG 148, 149, 154, or 468),

(2) Hepatobiliary system (i.e., DRG 197, 493, or 494),

(3) Female reproductive system (i.e., DRG 358, 359, 361, or 365),

(4) Pregnancy with evidence of Cesarean section (i.e., DRG 370, 371, or 378).

Study Measures

Study measures included the number of inpatient hospitalizations involving adhesiolysis, adhesiolysis-related hospitalization rates, days of care, and costs attributable to adhesiolysis.

Hospitalization rates per 100,000 persons were assessed using the US Census Bureau's 2005 total US civilian population projection. The total days of care attributable to adhesiolysis were estimated using methods presented by Ray and colleagues that then were adapted for the HCUP NIS [2]. When DRG 150 or 151 (i.e., primary adhesiolysis) was the primary reason for admission, the attributed LOS was simply the mean LOS for this group. For records without a DRG of 150 or 151, excess days attributed to adhesiolysis were calculated as the difference between the mean LOS for those same procedures with adhesiolysis and those procedures without adhesiolysis within each DRG. The total number of adhesiolysis-related days then was estimated as the product of the attributed LOS for the group and the number of adhesiolysis-related hospitalizations within the group.

This study utilized the methodology from Ray and colleagues to estimate the per-day cost attributable to adhesiolysis [2]. Cost per day was estimated by dividing the total cost of adhesiolysis-related hospitalizations divided by the total number of adhesiolysis-related inpatient days. The total inpatient expenditures attributable to adhesiolysis were estimated by multiplying the estimated cost per day attributable to adhesiolysis by the number of days attributed to adhesiolysis.

Average expenditures for surgeon's services were estimated using the Resource-Based Relative Value Scale (RBRVS). The RBRVS value was estimated for Current Procedural Terminology codes related to adhesiolysis (Table ​(Table2)2) and then multiplied by a fixed conversion factor to determine the average surgeon expenditures for each specific procedure. These figures then were inflated to 2007 dollars using the medical care component of the Consumer Price Index.

Table 2

Description of Procedure (CPT) Codes Used to Identify Adhesiolysis-Related Surgical Procedures to Estimate Expenditures for Surgeons' Servicesa

Total inpatient costs attributable to adhesiolysis consisted of inpatient costs and costs for the surgeon's services. Estimates were made separately for primary and secondary adhesiolysis. These also were examined by body system and then aggregated to estimate a total cost. Additionally, inpatient expenditures were summarized to compare Cesarean section deliveries with and without adhesiolysis.

Statistical Analyses

Descriptive analyses were conducted to display the mean, standard deviation, median, and range of continuous variables, as well as the frequency distribution of categorical variables. All data management and analyses were conducted with SAS and SUDAAN statistical software packages [14,15].

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Results and Discussion

Table ​Table33 illustrates that there were 351,777 adhesiolysis-related hospitalizations in the US in 2005, representing 119 adhesiolysis hospitalizations per 100,000 persons. There were 898 adhesiolysis hospitalizations per 100,000 hospitalizations and 3,549 per 100,000 surgical hospitalizations of any kind (3.5%). Primary adhesiolysis (i.e., DRG 150 or 151) was found in 23.2% of these hospitalizations, while the remaining 76.8% were classified as secondary adhesiolysis (i.e., evidence of the procedure but with a DRG other than 150 or 151).

Table 3

Rate of Adhesiolysis-Related Hospitalizations

Table ​Table44 presents background characteristics for the study sample. For primary adhesiolysis, the number of hospitalizations increased steadily by age; for secondary adhesiolysis, the number increased for most age categories. The lowest rate was in patients who were younger than 25 years (5.2 per 100,000 persons for primary adhesiolysis; 13.8 per 100,000 persons for secondary adhesiolysis), and the highest rate was in patients who were older than 65 years (88.4 per 100,000 persons for primary adhesiolysis; 176.7 per 100,000 persons for secondary adhesiolysis). Women had a higher hospitalization rate than men (34.9 vs. 19.7 per 100,000 persons for primary adhesiolysis; 153.1 vs. 13.4 per 100,000 persons for secondary adhesiolysis). Among primary adhesiolysis hospitalizations, almost half (48%) of the patients were admitted via the emergency department, whereas only 20.5% of the secondary adhesiolysis hospitalizations were via the emergency department. Primary adhesiolysis-related hospitalizations were evenly distributed between private insurance and governmental coverage, i.e., Medicaid and Medicare (44% and 48%, respectively), whereas more than half (56%) of the patients with secondary adhesiolysis hospitalizations had private insurance and 37.4% had government-sponsored health care coverage.

Table 4

Demographics and Other Patient- and Facility-Specific Characteristics of Interest Among Adhesiolysis-Related Hospitalizations (i.e., DRG 150 or 151) in the US in 2005

A total of 967,332 inpatient days of care were attributed to primary and secondary adhesiolysis (Table ​(Table5).5). There were 81,532 hospitalizations and an average LOS of 7.8 days per stay, totaling 632,688 inpatient days of care for primary adhesiolysis. An estimated 334,644 days of care were attributed to secondary adhesiolysis. For hospitalizations in which adhesiolysis was a secondary procedure, we compared the LOS between adhesiolysis and nonadhesiolysis procedures to estimate the LOS attributable to adhesiolysis by each DRG. The majority of DRGs showed an increase in LOS for adhesiolysis hospitalizations versus nonadhesiolysis hospitalizations. On average, hospitalizations related to secondary adhesiolysis resulted in an additional 1.24 hospitalized days compared with nonadhesiolysis-related hospitalizations.

Table 5

Inpatient Care Attributable to Abdominal Adhesiolysis by Surgical Procedure in the US in 2005

The difference in mean LOS was greatest for extensive operation room procedures unrelated to principal diagnosis (i.e., DRG 468), with 4.9 days attributable to adhesiolysis. For stomach, esophageal, and duodenal procedures with complications of comorbid conditions (i.e., DRG 154), 4.6 days were attributable to adhesiolysis. Almost half (46.3%) of all secondary adhesiolysis procedures (125,069) were female reproductive tract related, resulting in 57,005 days of care. Thus, 0.46 day of additional stay were attributable to adhesiolysis. The longest LOS for female reproductive system procedures was for DRG 358 (uterine and adnexa procedures for nonmalignancy), which resulted in an additional day of inpatient stay (0.90 day).

Table ​Table66 shows that total inpatient expenditures for adhesiolysis-related hospitalizations were $2.25 billion: of this amount, primary adhesiolysis-related hospitalizations accounted for $1.35 billion and secondary adhesiolysis-related hospitalizations accounted for $902 million. Of the total secondary adhesiolysis expenditures, $622 million (69%) were related to procedures for the digestive system and $220 million (24.3%) were related to procedures for the female reproductive system. Adhesiolysis related to the hepatobiliary system and pancreas and Cesarean sections accounted for $41 million and $18 million, respectively.

Table 6

Inpatient Expenditures Attributable to Abdominal Adhesiolysis in the US in 2005

The rate of adhesiolysis-related hospitalizations in the US has remained fairly constant from 1998 to 2005: from 115.5 in 1988 [10] to 117.3 in 1994 [2] and ultimately 118.6 per 100,000 persons in 2005. In these same time periods, the average LOS for primary adhesiolysis-related hospitalizations has steadily decreased from 11.2 days to 9.7 days and 7.8 days, respectively. The costs for such hospitalizations, when inflated to reflect 2007 dollars, indicated an increase of $112 million between 1988 and 2005, despite the 3.4-day (or 30%) decrease in LOS--this represented a 5% increase in medical care costs. This increase suggested that costs of treating adhesiolysis have increased substantially.

Primary adhesiolysis contributed 23% of all adhesiolysis procedures (81,532) but represented more than half of the total cost burden ($1.3 billion). Secondary adhesiolysis was substantially higher in volume, representing 77% of procedures (270,245) but less half of the total cost burden ($902 million). The greatest number of procedures was to the female reproductive tract (125,069) while procedures to the digestive tract yielded the highest overall costs ($622 million).

Potentially mitigating this growth in the cost of adhesiolysis may be the continuing trend in the US toward minimally invasive and laparoscopic approaches, which may lessen the occurrence of postoperative adhesions [2]. Although laparoscopy reduces surgical trauma, the procedure has not been show to reduce the incidence of adhesion-related readmissions [16].

This study is subject to potential limitations consistent with retrospective database studies. Conditions and events of interest were identified by diagnosis codes. Previous research has suggested that the condition may be underreported [17]. This may mean that the actual cost of adhesiolysis-related disease is greater than the estimate provided by our study. The database used for this study was not specifically designed to assess inpatient burden. Like all administrative billing databases, the data contained in the HCUP NIS are dependent upon the quality of coding, which may be influenced by reimbursement incentives. However, we do not feel it likely that such incentives greatly affected our results since the majority of overall adhesiolysis costs were a part of secondary adhesiolysis procedures and not the more costly primary adhesiolysis. Moreover, even if such incentives exist and are reflected in the data used for this study, these data are indicative of real world practice. Additionally, with such a large sample, the effect of any coding errors or anomalies would likely be minimized.

Furthermore, due to the nature of the database, detailed clinical characteristics could not be ascertained; therefore, the results could not be adjusted for disease severity or other clinical parameters. However, it is unlikely that these factors would have had a large impact on the results, as this study focused on those patients receiving inpatient care. Additionally, since the database contains US data only, the results may not be generalizable to other populations outside of the US. Lastly, because the focus of this study was on direct cost measures, the results do not account for productivity loss for the patient or caregiver and potential future societal contributions that may be lost due to death resulting from or related to adhesiolysis. Because we examined only the direct health care costs associated with inpatient adhesiolysis, we have not examined any adhesiolysis-related surgeries performed at other sites of care, such as ambulatory surgical centers. Further, our study does not capture direct costs relating to but occurring before or after surgery, including pain medications, cost of work-up visits, and procedures related to diagnosis. Similarly, patient work-ups and diagnostic laparoscopic procedures that may have occurred at separate visits and prior to the adhesiolysis surgery were not captured if specific DRG codes were not listed for those hospitalizations [6,7,9]. Hence, this study's estimates of costs are likely to be conservative.

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Conclusions

Adhesions remain an important surgical problem, and hospitalization for adhesiolysis leads to a high direct cost burden in the US. Despite a trend of decreasing LOS for adhesiolysis-related hospitalizations from 2001 to 2005, adhesiolysis-related costs continue to rise even while the overall rate of adhesiolysis procedures remains constant. Consistent with previous research, the distribution of inpatient care and costs across the diagnostic categories remained steady from 2001 to 2005, with only a slight increase in primary adhesiolysis procedures over time. From 2001 to 2005, hospitalizations for adhesiolysis related to the digestive system and to the female reproductive tract had the largest number of inpatient days and accounted for the majority of costs related to secondary adhesiolysis procedures.

Adhesiolysis remains a substantial economic burden to the US health care system, which should be of interest to providers and commercial and government payers. Further research incorporating detailed clinical data and indirect costs would aid in a greater understanding of the overall burden of adhesiolysis.

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Competing interests

VS was an employee of Ethicon, Inc. at the time that this manuscript was prepared; he is currently an employee of Shire Pharmaceuticals. BB, SDC, and KLD are employees of RTI Health Solutions, the research organization contracted by Ethicon to conduct this study. AJ is an employee of Texas Healthcare; MW is an employee of Christie NHS Foundation Trust.

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Authors' contributions

VS was responsible for developing the study design, interpreting the analysis results, and drafting the manuscript text; he is the primary author of this manuscript. BB, SDC, and KLD were responsible for the acquisition, management, interpretation, and analysis of all study data. BB, SDC, and KLD also assisted with developing the study design, interpreting the analysis results, and drafting the manuscript. AJ and MW contributed clinical expertise and guidance and assisted in interpreting the analysis results and drafting the manuscript text.

All authors confirm that they have read the journal's position on issues involved in ethical publication and affirm that this research report is consistent with those guidelines. Finally, all authors have read and approved the final manuscript.

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Funding

This study and the preparation of this manuscript were funded by Ethicon, Inc. The authors acknowledge that Ethicon, Inc. is the maker of GYNECARE INTERCEED, a product that is marketed to prevent pelvic adhesions.

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Pre-publication history

The pre-publication history for this paper can be accessed here:

http://www.biomedcentral.com/1471-2482/11/13/prepub

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Acknowledgements

Portions of the study data presented in this paper were previously presented as a podium presentation at the VIIIth PAX Meeting; Clermont-Ferrand, France; September 18-20, 2008, as well as a poster presentation at the 57th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists; Chicago, Illinois; May 2-6, 2009.

The authors wish to thank Ms. Gail Zona of RTI Health Solutions and Ms. Heidi Waters of Ethicon, Inc., for assistance with preparing this manuscript.

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Articles from BMC Surgery are provided here courtesy of BioMed Central

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3141363/