NO, NEVER!
Endogyn was a front where "unauthorized, unethical and immoral procedures" could be done from the start! Mettler, Reich and Kruschinski stumbled upon an "untapped" area of medicine, one not monitored and without precidents and they ran with it for the glory of THEMSELVES!
There were NEVER any authorized clinical studies performed there. Never! In fact, the much touted publication:
"Lift-(gasless) laparoscopic surgery under regional anesthesia Surg Technol Int 2005. 14: 193-6. X-6 (PubMed)" submitted by Kruschinski was found to be 100% unacceptable?
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http://www.ncbi.nlm.nih.gov/books/bv.fcgiindexed=google&rid=hstat1b.section. 57365 AHRQ Evidence reports and summaries AHRQ Evidence Reports, Numbers 120 & Higher 154. Management of Uterine Fibroids: An Update of the Evidence
Appendix D. List of Excluded StudiesExcluded Articles Full Text Article Exclusion Criteria Codes for Database
X-1: Not original research
X-2: Not published from February 2000-February 2006
X-3: Not published in English
X-4: Study not conducted in appropriate geographic location
X-5: Ineligible study design
X-6: Study does not answer study question878.
D Kruschinski and S Homburg. Lift-(gasless) laparoscopic surgery under regional anesthesia Surg Technol Int 2005. 14: 193-6. X-6 (PubMed)
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Helen Dynda and Karen Steward, and others, posted over and over in Endogyn message board their "accolades" to Kruschinski and Homberg for this wonderful "study" having been published! Remember? Well, they were very uneducated about this stuff as they were about everything else they tried to brainwash you folks with! Some of you listened without so much as doing your own research into this criminal surgeon!
(Not to mention you were under his knife and 100% vulnerable to his craziness and experiments!)
IHRT will continue to prove to you in upcoming IHRT posts that YOUR surgery at Endogyn was an experiment performed by a "psycho wannabee surgeon who created the biggest facade in medical history," that his "clinical studies" were anything but that, and that he and Mettler NEVER did one single authorized and recognized clinical study for anything together!
One might ask why did he do this. "Money, fame and control...nothing more, nothing less!"Facts relating to the, "Institute of Endoscopic Gynecology Centers" in Germany.
The following information validates that:
~NO clinical studies were ever authorized to be performed there!
~NO statistics on any procedures performed there were collected prior to patients from the USA going there for surgeries!
~NO videos of surgical procedures performed on patients form the USA were given to them!
~NO "adhesion lab" ever existed in association with Endogyn!
~NO studies associated with the "Abdolift"~ "Gas-less" in connection with "Confluent Spray-Gel" were completed there prior to patients from the USA going there for surgeries!
~VIDEOS of YOUR adhesiolysis procedures WERE recorded at Endogyn, and ALL were used as part of an "unauthorized" study by Daniel Kruschinski, Endogyn and Prof. Dr. L. Mettler in Kiel Germany! These so called, "studies" of YOUR surgeries were deemed not to be of any value to any other physician, facility, government dept., medical dept., or society simply because they were NOT performed under any recognized or authorized clinical protocol!
EVERY PATIENT from the USA was duped by Kru and Mettler!
If you, any of you, were patients to Endogyn, and think that the operating rooms where you had your surgery was NOT equipped with taping equipment, you are really in denial!
And, if you think that a video made in Germany cannot be viewed while you’re in Germany, think again!
If you really think that a "4-star" facility, as claimed by Kru, would NOT have this equipment, all IHRT can say is "what's up with your brain!?"
Consider that "surgical video" technology arrived in the 1980's, and any Endogyn facility that did not have that capability, just how much of a "4-star" facility were they?
(1982 - First solid state camera was introduced. This is the start of "video-laparoscopy" http://www.laparoscopy.com/shows/lapstry8.htm)
"Cough, choke" area coming up...........Though it pains IHRT to share this, the facts speak for themselves, so there is no reason to withhold the following information...Helen Dynda and Karen Stewart, among others, were innocent of these facts, they did not know this when they started the harvesting, backing and obsessive behaviors they exhibited with this con-Dr! They, along with many who have greater medical and legal knowledge, and common sense, were simply duped by Kru and Mettler, (and why not professional people in many other countries add onto that list as well!)
The wrong done to YOU by Helen and Karen, and a few others, was that they harvested patients to Endogyn using false information they never validated!!
Side note: Interestingly enough folks, it that it is against the law in Germany for surgeons, in this case, to charge patients who are knowingly taking part in clinical studies for the procedure being researched by them! The key word here though is, "knowingly!
"IHRT now presents for your examination the following "paid to submit” articles by D. Kruschinski and S. Homberg, reflecting on the dates of these "studies.”
IHRT encourages you to ask yourself these questions as you read these "papers."
"Where are the clinical studies, statistics, and/or research material that I was told existed prior to me going to Endogyn?"
"Was I the "Human Test" subject used to collect this data?"
"Did I pay to be a "Human Experiment" so that Kruschinski and Mettler could scam other medical professionals for their personal gain?"
"Why isn't Helen posting in Endogyn anymore?"
"Why isn't Karen "harvesting" any patients to all of the "Endogyn" facilities in Germany?"
"Where were the "other" Endogyn facilities in Germany that Kruschinski mentions in these articles as having taken part in these "studies??" (You all know there were none, unless you want to stay in denial if that feels more comfortable!)
Enough said by IHRT as we WILL give you some benefit of our doubts about you being capable of figuring these "studies" out for yourself, they are "wordy," but in actuality, they say nothing at all...have at 'em!
Surg Technol Int. 2006 Jul ;XV :131-139 17029173
Adhesiolysis in Severe and Reccurent Cases of Adhesions Related Disorder (ARD) - A Novel Approach Utilizing Lift (Gasless) Laparoscopy and SprayGeltrade mark Adhesion Barrier - ump.com.[My paper] Daniel Kruschinski , Shirli Homburg , Fabian D'Souza , Patrick Campbell , Harry Reich
We investigated the feasibility and outcome of adhesiolysis in patients with severe and reccurent adhesions using lift (gasless) laparoscopy and a SprayGeltrade mark adhesion barrier at the Institute for Endoscopic Gynecology (EndoGyn(R)). The design included a prospective evaluation of lift (gasless) laparoscopic adhesiolysis in combination with a SprayGeltrade mark adhesion barrier. A new score for bowel adhesions was developed and applied. All 35 patients with severe and reccurent adhesions underwent a lift-laparoscopic adhesiolysis with the Abdo-Lifttrade mark and SprayGeltrade mark adhesion barrier, a second-look laparoscopy at Day 7 and, in case of continuation of pain, a third-look laparoscopy within 6 months after the initial surgery. All patients were operated upon without conversion to laparotomy. The reduction in the adhesion score of adhesions at the second-look laparoscopy was overall (sum) 89.8% (90.1% reduction in extent, 89.3% reduction in severity, and 89.9% reduction in grade). Five patients (14.3%) had a third-look laparoscopy within 6 months after the initial surgery, in which four cases of adhesion reformation were confirmed. However, the scores were reduced compared to the initial surgery, especially in grade (94.2%) and severity (93.2%). In these analyses, SprayGeltrade mark was uniquely effective in improving the success rates of adhesiolysis when combined with lift (gasless) laparoscopy and good hemostasis techniques. Adhesiolysis with Abdo-Lifttrade mark and SprayGeltrade mark had unparalleled efficacy in the adhesiolysis procedure even in those patients in whom other solutions have not worked. An overall reduction of adhesions by 89.9% at second-look laparoscopy was found. Even if five patients (14.3%) required a third-look laparoscopy where four cases of adhesion reformation were confirmed, the scores were reduced when compared to the initial surgery, especially in grade and severity.
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Note: Regarding the "article" below.....IHRT suggests that you "google" Canadian Task Force classification II-1 and see all the connections that it has to "Endogyn!"
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Surg Technol Int. 2005 ;14 :193-6 16525973
Lift-(gasless) laparoscopic surgery under regional anesthesia.
[My paper] Daniel Kruschinski , Shirli Homburg
T he objective of this Chapter was to investigate the feasibility and outcome of gasless laparoscopy under regional anesthesia. A prospective evaluation of Lift-(gasless) laparoscopic procedures under regional anesthesia (Canadian Task Force classification II-1) was done at three endoscopic gynecology centers (franchise system of EndGyn(r)). Sixty-three patients with gynecological diseases comprised the cohort. All patients underwent Lift-laparoscopic surgery under regional anesthesia: 10 patients for diagnostic purposes, 17 for surgery of ovarian tumors, 14 to remove fibroids, and 22 for hysterectomies. All patients were operated without conversion to general anesthesia and without perioperative or anesthesiologic complications. Lift-laparoscopy under regional anesthesia can be recommended to all patients who desire laparoscopic intervention without general anesthesia. For elderly patients, those with cardiopulmonary risks, during pregnancy, or with contraindications for general anesthesia, Lift-laparoscopy under regional anesthesia should be the procedure of choice.
Surg Technol Int. 2004 ;13 :147-56 15744685
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Lift-laparoscopic total hysterectomy as a routine procedure.
[My paper] Daniel Kruschinski , Shirli Homburg , Achim Wöckel , Anupam Kapur , Harry Reich
In this study, laparoscopic hysterectomy was done with a special lift system that elevates the abdominal wall without carbon dioxide (CO2) insufflation. During this procedure, bipolar diathermy scissors also were used, which disconnected the uterus from its vessels and ligaments. The uterus was then removed through the vagina. In 403 cases, variables including operation time, complication rate, blood loss, postoperative pain, hospital stay, vaginal discharge, and convalescence time were examined. Compared with other laparoscopic methods [laparoscopic-assisted vaginal hysterectomy (LAVH), supracervical hysterectomy, and total laparoscopic hysterectomy], all those examined showed better results. Further advantages of the gasless Lift-laparoscopic total hysterectomy are lower costs and an effective "learning curve." Use of this method routinely could decrease the number of conventional-surgical hysterectomies that result in additional complications.
Mesh-terms: Adult; Age Factors; Aged; Blood Loss, Surgical, prevention & control; Cohort Studies; Female; Follow-Up Studies; Humans; Hysterectomy, Vaginal, instrumentation; Hysterectomy, Vaginal, methods; Hysteroscopes; Hysteroscopy, adverse effects; Hysteroscopy, methods; Laparoscopy, methods; Length of Stay; Middle Aged; Patient Satisfaction; Postoperative Complications, prevention & control; Retrospective Studies; Risk Assessment; Severity of Illness Index; Surgical Procedures, Minimally Invasive, instrumentation; Surgical Procedures, Minimally Invasive, methods; Treatment Outcome; Uterine Diseases, diagnosis; Uterine Diseases, surgery;
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Here is one of only a couple clinical studies that Prof. Dr L. Mettler was actually involved in, and it is obvious where Daniel Krusksinski copied the format of his "clinical studies" which were written only by himself, and plastered all over Endogyn! IHRT will also walk you through the "history" of Prof. Dr. L. Mettler and show you that she has really accomplished little when it comes to "adhesion" studies. and why her CV in Endogyn is worthless!
IMPACT SUMMARY:
SprayGel® is a new adhesion prevention system developed for use intra-operatively. SprayGel has shown to provide some prevention in adhesion formation in ovarian surgery patients without major adverse events. The system is currently available in Australia and New Zealand.BackgroundAdhesions (also called pelvic adhesions, intraperitoneal adhesions) are abnormal scar-like bands that form between two surfaces inside the body. Their formation can be a result of peritoneal damage, intra-abdominal ischemia or the presence of foreign materials in the abdominal cavity (e.g. surgical glove powder, micro-organisms, gauze lint, sutures and prosthetic mesh) (Mettler et al. 2002). Adhesions can range in severity from, thin film-like bands to thick fibrous bands. Although adhesions are not associated with specific symptoms, people with adhesions may experience pain (resulting from the pulling of nerves at the site of adhesions), intestinal obstruction, infertility and increased rate of complications during subsequent surgeries (Ellis et al. 1999). Adhesions can occur anywhere within the peritoneal cavities. There are several causes of adhesion formation including endometriosis, attacks of appendicitis and pelvic inflammatory disease. However the most common cause of adhesion formation is surgery (Johns et al. 2003).Treatment of adhesions involves the cutting or releasing of the adhesions through a process called adhesiolysis, a procedure which can be performed via laparoscopy or laparotomy (Szomstein et al. 2006). The surgery is performed to allow normal movement of the affected organs. Unfortunately, even after adhesiolysis has been performed up to two-thirds of patients will experience recurrence (Mettler et al. 2002). Given that even adhesiolysis surgery can cause adhesion formation, surgeons use various surgical techniques in an attempt to prevent adhesion formation. These include: avoidance of the introduction of foreign bodies into the cavity (e.g. surgical glove powder), limiting unnecessary handling of organs, avoiding the use of dry sponges and irrigating the cavity during the surgical procedure, avoiding unnecessary damage to organs, tissues and blood vessels, and using the finest size suture thread appropriate to the surgery. The SprayGel adhesion barrier system is designed to minimise adhesion formation and consists of two separate polyethylene glycol (PEG) based liquids that when mixed together (upon application) quickly cross-link to form a biocompatible flexible, absorbable hydrogel in situ. The SprayGel component liquids are sprayed onto the target tissue(s) with an air-assisted sprayer which can be used in either endoscopic or open procedures. SprayGel remains intact for five to seven days preventing fibrin deposition and fibrinolysis and after which it breaks down into water-soluble PEG components that undergo renal clearance.
CLINICAL NEED AND BURDEN OF DISEASE
It has been reported that adhesions occur in 68% to 100% of patients who have undergone one or more laparotomies (Ellis 1997, Luijendijk et al. 1996, Menzies and Ellis 1990). Previous abdominal surgery has been described as the single most important predictive factor of adhesion formation (Szomstein et al. 2006).Adhesions can have severe implications for sufferers. Sufferers of abdominal adhesions can suffer chronic abdominal pain as well as develop small bowel obstructions. Female sufferers of pelvic adhesions (involving the uterus, ovaries, fallopian tubes or bladder) may develop reproductive complications including infertility and ectopic pregnancy. Finally, sufferers of heart adhesions may suffer from decreased heart efficiency.Unfortunately, the majority of adhesion barriers and agents used for prevention of adhesion formation are difficult to use in open surgery settings and even more difficult under laparoscopic surgery settings (Mettler et al. 2002).
DIFFUSION
The SprayGel adhesion barrier is currently not approved for sale in the United States. The barrier has received CE Mark and is available in the European community. The system is also available in Australia, New Zealand, South Africa, UAE, Oman, Qatar, Bahrain, Israel, Saudi Arabia and Lebanon.The extent of diffusion of the SprayGel adhesion barrier in Australia was not revealed in the searches conducted.
COMPARATORS
Various barriers have been evaluated to reduce or prevent adhesion formation. However, many are difficult apply under laparoscopic conditions, have unsuitable absorption times or are associated with increased adverse events (Mettler et al. 2004).Other adhesion barriers suitable for abdominal and ovarian surgery include:• Gynecare Interceed (TC7) Absorbable Adhesion Barrier (Ethicon, Inc.)• Seprafilm Adhesion Barrier (Genzyme Corporation)• ADEPT (ML Laboratories)
SAFETY AND EFFECTIVENESS ISSUES
The first clinical evaluation of SprayGel was conducted as a multi-centre study investigating the safety and effectiveness of the barrier in women undergoing open or laparoscopic myomectomy procedures. Three publications reporting results from the same study were retrieved in the literature search (Mettler et al. 2003a, Mettler et al. 2003b, Mettler et al. 2004). Only results from the most recent, detailed study are presented (Mettler et al. 2004). In this prospective, randomised, controlled phase III study, patients undergoing open or laparoscopic surgery for leiomyoma or leimyomatous uteri were assigned to receive the SprayGel adhesion barrier plus optimal surgical technique (treatment group) or optimal surgical technique alone (control group). Following myomectomy, patients were randomly allocated to either the treatment or control group. At each site, the first eligible patient was not randomised but instead received treatment with SprayGel to familiarise the investigators with its use (these patients were followed-up for safety analysis only). All patients who received application of the SprayGel barrier had suture lines and all potentially adhesiogenic surfaces on the uterus and adjacent structures coated to a thickness of approximately 0.5 mm to 1.0 mm. Of the 69 women enrolled, five did not proceed to randomisation (two training patients and three study withdrawals). Therefore, 64 were included in the efficacy evaluation (34 treatment and 30 control group patients) and 66 in the safety evaluation (including the two training patients). The uterine myomectomy procedure and thus application of the SprayGel barrier was performed laparoscopically in 28 (82.4%) of treatment and 23 (76.7%) of control patients. The authors noted that application of the SprayGel barrier was easy in both laparoscopic and open procedures with mean time of application of 3.7 minutes and average requirement of 1.9 kits per treatment patient. There were no adverse events related to the use of the SprayGel barrier.The primary efficacy outcomes were incidence1, severity2 and extent3 of adhesions measured at the second look laparoscopy (SLL), which was performed between three and 16 weeks after surgery. Twenty-two (64.7%) treatment and 18 (60%) control group patients returned for SLL. Despite the high attrition rates, no significant differences between patients who returned and those who did not were found. Prior to surgery, patients in both groups had similar incidence, severity and extent of adhesions. At the SLL there were no significant differences between groups in regards to extent of adhesions with both groups having similar median areas of the uterus covered with adhesions (p > 0.1). Although treatment patients experienced lower incidence than control patients (31.8% versus 11.1% adhesion free, respectively), no statistically significant difference was observed. Treatment group patients experienced significantly lower severity as shown by a lower mean tenacity score than the control group (1.0 versus 1.9, p = 0.002). In terms of recurrent adhesions, no statistical difference between the two groups was reported.Comparison of SLL to initial myomectomy values revealed patients who did not receive SprayGel were at an increased risk of forming adhesions compared to patients in the treatment group, demonstrated by increased incidence of adhesions (0.64 for treatment versus 1.22 for control, p = 0.035). Similarly, severity at the SLL was significantly lower for treatment group patients than at the initial surgery compared to control group patients (0.6 for treatment versus 1.7 for control, p = 0.001). No statistically significant difference in the extent of adhesion was noted with both groups having similar increase in the adhesion area from initial surgery to SLL (4.5 cm2 for treatment versus 7.2 cm2 for control, p > 0.1).Johns and colleagues conducted another randomised controlled trial of the SprayGel adhesion barrier to investigate its impact on frequency of adhesion formation and reformation after ovarian surgery (Johns et al. 2003). In this study 14 women undergoing laparoscopic ovarian surgery were randomised to have one ovary treated with SprayGel and the other with good surgical technique only. Patients who received the SprayGel treatment had the barrier applied to the entire surface of the relevant ovary and immediately adjacent structures with the air-assisted applicator. No SprayGel was applied to any contralateral structures.At the SLL treated ovaries demonstrated a reduction in adhesion formation of 21.4% (p value not reported) and a significantly lower extent of adhesion cover over the treated ovary (control mean extent surface are 52.0%, treated mean extent surface area 29.6% , p = 0.0298). Additionally the mean severity score was lower for the treated ovaries (mean 2.1) than for the control (mean 2.7) ovaries although statistical significance was not reported. The frequency and extent of adhesion formation on ovaries, fallopian tubes and pelvic side walls were also evaluated by an independent reviewer who determined that the change in both frequency and extent between the initial surgery and the SLL were significantly lower in the treated ovary side compared to the control side (p = 0.0488 for frequency and p = 0.0494 for extent). The frequency in the treated sides increased from 3.21 (initial surgery) to 4.21 (SLL) compared to 2.57 (initial surgery) and 6.07 (SLL) for the control side. Similarly extent of adhesions increased from 5.46 cm2 at the initial surgery to 10.97 cm2 at the SLL.No adverse events related to the use of the SprayGel barrier were reported.COST IMPACTA search of the published literature and website of the manufacturer of SprayGel (Confluent Surgical Inc., Massachusetts, United States) did not reveal the cost of SprayGel.1 Incidence: defined as mean number of sites adherent to the uterus2 Severity: defined as mean adhesion tenacity score, ranging from 0 to 3: 0 = no adhesions, 1 = filmy or vascular adhesions, 2 = vascular and/or dense adhesions, 3 = cohesive adhesions3 Extent: defined as mean area of uterus covered by adhesions, cm2The Medicare Benefits Schedule reimbursement fees for procedures related to the treatment of adhesions are listed in Table 1:Table 1: Medical Benefits Schedule of fees for procedures related to the treatment of adhesions (Department of Health and Ageing 2007)CategoryItem Number Benefit (AUD) Number of Claims (July 2005 to June 2006)Laparotomy for the division of peritoneal adhesions30376 $460.55 456Laparotomy involving division of adhesions in conjunction with another intra-abdominal procedure where time to divide adhesions is between 45 minutes and 2 hours30378 $462.70 4,381Laparotomy with division of extensive adhesions (duration greater than 2 hours)30379 $820.15 1,195Laparoscopic division of adhesions in association with another intra-abdominal procedure where time taken to divide adhesions exceeds 45 minutes 30393 $462.70 4,686 Laparoscopic division of adhesions, as independent procedure lasting 1 hour or less 31450 $359.35 284 Laparoscopic division if adhesions, as an independent procedure lasting more than 1 hour 31452 $628.70 248 Thoracotomy or sternotomy involving division of adhesions where time taken exceeds 45 minutes38643 $943.15 559 Thoracotomy or sternotomy involving division of adhesions where time taken exceeds 2 hours 38647 $1,886.15 489 ETHICAL, CULTURAL OR RELIGIOUS CONSIDERATIONS No issues were identified from the retrieved material.
Stand by for more validation of "clinical" experiments performed by Kruschinski aka Endogyn!
You might also be interest to check this link out to see who is NOT invited to the: (Hint: Gas-less laporoscopy doesn't seem to be if interest these days!)
AsianAmerican MultiSpecialty Summit III: Laparoscopy and Minimally Invasive Surgery: February 6–9, 2008
http://laparoscopy.blogs.com/asianamerican_summit/2007/07/preliminary-pro.html
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