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Post-surgical adhesion prevention with a biodegradable gel compatible with laparoscopic use
Selected Scientific Abstracts
(23%); Uterine prolapse, 6 (14%); endometriosis, 6 (14%); and 1 cervical carcinoma. Four complications occurred. One intraoperative large bowel perforation associated with extensive adhesions occurred and perforation was converted into an abdomial hysterectomy. The performation was repaired primarily. The 3 remaining complications were delayed vaginal cuff bleeding, one of which required return to the operating room on post-operative day 25 for suturing of the vaginal cuff. The average length of stay was 3 days (range 2-8). The author reviewed the general experience of introducing this new procedure into a community hospital and concluded that LAVH is efficacious and can be safely introduced into a community hospital setting.
operative laparoscopy. While operative laparoscopy amounted to 70% (n=316) of all operations in 1990, it was 87% (n=515) in 1993. Additionally, the positive experience with minimally invasive surgery permitted us to enlarge the spectrum of indications for operative laparoscopy considerably, so that extensive adhesiolysis within the entire abdominal cavity (n--78 in 1993), adnexal surgery in pre- and postmenopausal women (n=254 in 1993), and laparoscopic hysterectomy (n=71 in 1993) have b e c o m e r o u t i n e today. Morbidity of patients after operative laparoscopy was significantly lower than after laparotomy. Our experiences support the view that operative laparoscopy is not only a benefit to selected subgroups of patients but may be applied successfully to the majority of women requiring gynecologic surgery.
Transcervical Tubal Catheterization Utilizing Flexible Hysteroscopy is an Effective Method of Treating Cornual Obstruction: A Review Of 120 Cases
Manifestation of Endocrine Deficiency after Sterilization
RK Burke. Fertility and Women's Health Care Center, Mercy Hospital, Springfield, MA; Department of Ob/Gyn, Division of Reproductive Endocrinology, University of Massachusetts Medical School, Worcester, MA.
T Brosche, HH Riedel. Endoscopy Center and Department of Ob/Gyn, Regional Hospital Zwickau, Zwickau, Germany. Sterilizations have increased during the past 3 years in the new federal countries of G e r m a n y . Whereas approximately 800 procedures were perf o r m e d in the years 1989/90, our c u r r e n t study revealed that approximately 20,000 procedures were performed from 5/31/91-6/1/92. This development and the fact that we coagulated the uterine tubes with endocoagulation and bipolar high frequency methods p r o m p t e d us to u n d e r t a k e a study to determine whether endocrine deficiency resulted after sterilization. The results revealed that the sterilization caused postoperative changes of menstruation in more than 20% of the women. Climacteric difficulties were present in a b o u t 4% of the cases. We c o n c l u d e d endocrine evaluation of these patients which confirmed our clinical results.
The author reviewed a 3 year experience in the treatment of bilateral cornual obstruction using an Olympus 4.7 mm flexible, operating hysteroscope (Olympus HYF-P) with a modified Katayama transcervical tubal catheter (Cook, Inc.) and concomitant laparoscopy. Of 120 patients undergoing treatment of bilateral cornual obstruction, the following results were obtained: post-operative patencies, 96; pregnancies, 48, of which 2 were ectopic; and reocclusions, 12. Of the reocclusions, 8 were treated with flouroscopic catheterization of which two achieved normal pregnancies. The sole complication was a single cornual perforation with the tubal catheter. The results are statistically significant and indicate that the endoscopic treatment of bilateral tubal obstruction is effective.
Laparoscopically Assisted Vaginal Hysterectomy (LAVH) in a Community Hospital: An Initial Experience
Post-Surgical Adhesion Prevention with a Biodegradable Gel Compatible with Laparoscopic Use
RK Burke. Fertility and Women's Health Care Center, Mercy Hospital, Springfield, MA; Department of Ob/Gyn, Division of Reproductive Endocrinology, University of Massachusetts Medical School, Worcester, MA.
lW Burns, K Skinner, J Colt, K Greenwalt. Biopolymers Department, Genzyme Corporation, Cambridge, MA. A useful laparoscopic product for adhesion prevention must be easy to apply with minimal handling and manipulation of tissue and product. With this objective in mind, we have developed an injectable gel (HAL TM)based on hyaluronic acid that is intend-
A total of 44 procedures were begun as LAVH with 41 (93%) completed and 3 (7%) attempted but converted to an open approach. Indications were: Leiomyata uteri, 21 (48%); menometrorrhagia, 10
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August 1994, Vol. 1, No. 4, Part 2
The Journal of the American Association of Gynecologic Laparoscopists
ed to limit adhesion formation after laparoscopic and open surgical procedures. We tested the effectiveness of HAL T M gels in a rat sidewall defect model. In 50 adult female rats a 1 cm x 1 cm peritoneal defect was made along the abdominal wall. The defect was enclosed with #3-0 silk suture to induce ischemia. The animals were randomized to gel treatment (0.5 ml placed on defect) or non-treatment control groups. Seven days after surgery the extent (0-4 scale) and severity (0-3 scale) of adhesions were scored.
ing, including the assessment of the upper abdomen, was begun laparoscopicaUy. When a cancer was managed l a p a r o s c o p i c a l l y , an early s e c o n d look laparoscopy was performed routinely. Since m a n y l a p a r o t o m i e s may be a v o i d e d , laparoscopic surgery is promising in the management of suspicious adnexal masses. However, from two cases of tumor dissemination, we conclude that this m a n a g e m e n t should follow strict guidelines and needs to be further evaluated.
Treatment Group
Adenomyosis as a Major Cause for LaparoscopicAssisted Vaginal Hysterectomy for Chronic Pelvic Pain
N Extent
Severity Total Score
No. Of Animals w/No
Adhesions Control 20 2.1_+0.3 1.7_+0.2 3.8_+0.5 4/20(20%) HALTMgel 30 0.5_+0.1a 0.7_+0.2a 1.2_+0.3" 20/30(67%) b
qE Carter, 21Kong. 1Department of Ob/Gyn, University of California College of Medicine, Irvine, CA; 2Women's Health Center of South Orange County, Inc., Mission Viejo, CA.
*Adhesions were scored without knowledge of group assignment; ap<0.001 Mann Whitney test; bp<0.005 Chi Square analysis.
Ninety-three women in whom conservative surgical therapy for chronic pelvic pain failed required hysterectomy for control of their disabling condition. In 22 of these 93 patients (24%), adenomyosis was the major pathologic finding. In 10 of the 22 (45%) women who had adenomyosis and required hysterectomy for control of their pain, tubal ligation had been previously performed. Only 15% (11/71) of patients without adenomyosis had had a tubal ligation. Over 23% of patients requiring hysterectomy for control of chronic severe pelvic pain had adenomyosis, and almost half of these women had had a tubal ligation performed. The possible relationship of adenomyosis to a previous tubal ligation has been explored.
H A L T M gel significantly reduced the extent and severity of sidewall adhesions. Moreover, the number of animals with no a d h e s i o n s was significantly increased c o m p a r e d with n o n - t r e a t m e n t . These results indicate that H A L T M gel, which is easily applied to tissue and organs, may be a useful adjuvant for adhesion prevention in open and laparoscopic surgical procedures. The effectiveness and safety of HAL T M gels will be tested in human clinical studies.
Laparoscopic Management of Suspicious Adnexal Masses M Canis, G Mage, JL Pouly, A Wattiez, E Glowaczower, J Raiga, MA Bruhat. Polyclinique de I'HoteI-Dieu C.H.R.U., Clermont, Ferrand, France.
Laparoscopic Treatment for Chronic Pelvic Pain: Results from Three-Year Follow-up
After our initial experience with 757 patients, we have extended our indications for laparoscopy to suspicious adnexal masses. Twenty of 29 ovarian cancers surgically treated since December 1991 were first evaluated by laparoscopy. In all, 321 patients were evaluated by laparoscopy in 1992 and 1993, including 145 women with an ultrasonographically suspicious mass (45.7%). At laparoscopy, 52 masses were diagnosed as suspicious, including 20 cases of malignant ovarian tumors. Sixteen patients were treated by laparotomy (5%), including 11 women with cancer, 2 with teratomas diagnosed as suspicious, and 3 with benign masses that could not be treated endoscopically (0.9%). In cancer treated by laparotomy, stag-
JE Carter. Department of Ob/Gyn, University of California, Irvine, College of Medicine, Irvine, CA. One hundred patients were treated with laparoscopic techniques for chronic pelvic pain. These procedures included uterosacral nerve vaporization, resection and vaporization of endometriosis, hernia repair, appendectomy, presacral neurectomy, and ovarian surgery. Follow-up over a 3 year period revealed the following results. Women with significant e n d o m e t r i o s i s had a 75% cure rate with a change in quality of life index from a preoperative level of pain of 8 to a postoperative level of pain of 2. A Score of 1 is no pain and 10 is maximum pain.
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(23%); Uterine prolapse, 6 (14%); endometriosis, 6 (14%); and 1 cervical carcinoma. Four complications occurred. One intraoperative large bowel perforation associated with extensive adhesions occurred and perforation was converted into an abdomial hysterectomy. The performation was repaired primarily. The 3 remaining complications were delayed vaginal cuff bleeding, one of which required return to the operating room on post-operative day 25 for suturing of the vaginal cuff. The average length of stay was 3 days (range 2-8). The author reviewed the general experience of introducing this new procedure into a community hospital and concluded that LAVH is efficacious and can be safely introduced into a community hospital setting.
operative laparoscopy. While operative laparoscopy amounted to 70% (n=316) of all operations in 1990, it was 87% (n=515) in 1993. Additionally, the positive experience with minimally invasive surgery permitted us to enlarge the spectrum of indications for operative laparoscopy considerably, so that extensive adhesiolysis within the entire abdominal cavity (n--78 in 1993), adnexal surgery in pre- and postmenopausal women (n=254 in 1993), and laparoscopic hysterectomy (n=71 in 1993) have b e c o m e r o u t i n e today. Morbidity of patients after operative laparoscopy was significantly lower than after laparotomy. Our experiences support the view that operative laparoscopy is not only a benefit to selected subgroups of patients but may be applied successfully to the majority of women requiring gynecologic surgery.
Transcervical Tubal Catheterization Utilizing Flexible Hysteroscopy is an Effective Method of Treating Cornual Obstruction: A Review Of 120 Cases
Manifestation of Endocrine Deficiency after Sterilization
RK Burke. Fertility and Women's Health Care Center, Mercy Hospital, Springfield, MA; Department of Ob/Gyn, Division of Reproductive Endocrinology, University of Massachusetts Medical School, Worcester, MA.
T Brosche, HH Riedel. Endoscopy Center and Department of Ob/Gyn, Regional Hospital Zwickau, Zwickau, Germany. Sterilizations have increased during the past 3 years in the new federal countries of G e r m a n y . Whereas approximately 800 procedures were perf o r m e d in the years 1989/90, our c u r r e n t study revealed that approximately 20,000 procedures were performed from 5/31/91-6/1/92. This development and the fact that we coagulated the uterine tubes with endocoagulation and bipolar high frequency methods p r o m p t e d us to u n d e r t a k e a study to determine whether endocrine deficiency resulted after sterilization. The results revealed that the sterilization caused postoperative changes of menstruation in more than 20% of the women. Climacteric difficulties were present in a b o u t 4% of the cases. We c o n c l u d e d endocrine evaluation of these patients which confirmed our clinical results.
The author reviewed a 3 year experience in the treatment of bilateral cornual obstruction using an Olympus 4.7 mm flexible, operating hysteroscope (Olympus HYF-P) with a modified Katayama transcervical tubal catheter (Cook, Inc.) and concomitant laparoscopy. Of 120 patients undergoing treatment of bilateral cornual obstruction, the following results were obtained: post-operative patencies, 96; pregnancies, 48, of which 2 were ectopic; and reocclusions, 12. Of the reocclusions, 8 were treated with flouroscopic catheterization of which two achieved normal pregnancies. The sole complication was a single cornual perforation with the tubal catheter. The results are statistically significant and indicate that the endoscopic treatment of bilateral tubal obstruction is effective.
Laparoscopically Assisted Vaginal Hysterectomy (LAVH) in a Community Hospital: An Initial Experience
Post-Surgical Adhesion Prevention with a Biodegradable Gel Compatible with Laparoscopic Use
RK Burke. Fertility and Women's Health Care Center, Mercy Hospital, Springfield, MA; Department of Ob/Gyn, Division of Reproductive Endocrinology, University of Massachusetts Medical School, Worcester, MA.
lW Burns, K Skinner, J Colt, K Greenwalt. Biopolymers Department, Genzyme Corporation, Cambridge, MA. A useful laparoscopic product for adhesion prevention must be easy to apply with minimal handling and manipulation of tissue and product. With this objective in mind, we have developed an injectable gel (HAL TM)based on hyaluronic acid that is intend-
A total of 44 procedures were begun as LAVH with 41 (93%) completed and 3 (7%) attempted but converted to an open approach. Indications were: Leiomyata uteri, 21 (48%); menometrorrhagia, 10
$5
August 1994, Vol. 1, No. 4, Part 2
The Journal of the American Association of Gynecologic Laparoscopists
ed to limit adhesion formation after laparoscopic and open surgical procedures. We tested the effectiveness of HAL T M gels in a rat sidewall defect model. In 50 adult female rats a 1 cm x 1 cm peritoneal defect was made along the abdominal wall. The defect was enclosed with #3-0 silk suture to induce ischemia. The animals were randomized to gel treatment (0.5 ml placed on defect) or non-treatment control groups. Seven days after surgery the extent (0-4 scale) and severity (0-3 scale) of adhesions were scored.
ing, including the assessment of the upper abdomen, was begun laparoscopicaUy. When a cancer was managed l a p a r o s c o p i c a l l y , an early s e c o n d look laparoscopy was performed routinely. Since m a n y l a p a r o t o m i e s may be a v o i d e d , laparoscopic surgery is promising in the management of suspicious adnexal masses. However, from two cases of tumor dissemination, we conclude that this m a n a g e m e n t should follow strict guidelines and needs to be further evaluated.
Treatment Group
Adenomyosis as a Major Cause for LaparoscopicAssisted Vaginal Hysterectomy for Chronic Pelvic Pain
N Extent
Severity Total Score
No. Of Animals w/No
Adhesions Control 20 2.1_+0.3 1.7_+0.2 3.8_+0.5 4/20(20%) HALTMgel 30 0.5_+0.1a 0.7_+0.2a 1.2_+0.3" 20/30(67%) b
qE Carter, 21Kong. 1Department of Ob/Gyn, University of California College of Medicine, Irvine, CA; 2Women's Health Center of South Orange County, Inc., Mission Viejo, CA.
*Adhesions were scored without knowledge of group assignment; ap<0.001 Mann Whitney test; bp<0.005 Chi Square analysis.
Ninety-three women in whom conservative surgical therapy for chronic pelvic pain failed required hysterectomy for control of their disabling condition. In 22 of these 93 patients (24%), adenomyosis was the major pathologic finding. In 10 of the 22 (45%) women who had adenomyosis and required hysterectomy for control of their pain, tubal ligation had been previously performed. Only 15% (11/71) of patients without adenomyosis had had a tubal ligation. Over 23% of patients requiring hysterectomy for control of chronic severe pelvic pain had adenomyosis, and almost half of these women had had a tubal ligation performed. The possible relationship of adenomyosis to a previous tubal ligation has been explored.
H A L T M gel significantly reduced the extent and severity of sidewall adhesions. Moreover, the number of animals with no a d h e s i o n s was significantly increased c o m p a r e d with n o n - t r e a t m e n t . These results indicate that H A L T M gel, which is easily applied to tissue and organs, may be a useful adjuvant for adhesion prevention in open and laparoscopic surgical procedures. The effectiveness and safety of HAL T M gels will be tested in human clinical studies.
Laparoscopic Management of Suspicious Adnexal Masses M Canis, G Mage, JL Pouly, A Wattiez, E Glowaczower, J Raiga, MA Bruhat. Polyclinique de I'HoteI-Dieu C.H.R.U., Clermont, Ferrand, France.
Laparoscopic Treatment for Chronic Pelvic Pain: Results from Three-Year Follow-up
After our initial experience with 757 patients, we have extended our indications for laparoscopy to suspicious adnexal masses. Twenty of 29 ovarian cancers surgically treated since December 1991 were first evaluated by laparoscopy. In all, 321 patients were evaluated by laparoscopy in 1992 and 1993, including 145 women with an ultrasonographically suspicious mass (45.7%). At laparoscopy, 52 masses were diagnosed as suspicious, including 20 cases of malignant ovarian tumors. Sixteen patients were treated by laparotomy (5%), including 11 women with cancer, 2 with teratomas diagnosed as suspicious, and 3 with benign masses that could not be treated endoscopically (0.9%). In cancer treated by laparotomy, stag-
JE Carter. Department of Ob/Gyn, University of California, Irvine, College of Medicine, Irvine, CA. One hundred patients were treated with laparoscopic techniques for chronic pelvic pain. These procedures included uterosacral nerve vaporization, resection and vaporization of endometriosis, hernia repair, appendectomy, presacral neurectomy, and ovarian surgery. Follow-up over a 3 year period revealed the following results. Women with significant e n d o m e t r i o s i s had a 75% cure rate with a change in quality of life index from a preoperative level of pain of 8 to a postoperative level of pain of 2. A Score of 1 is no pain and 10 is maximum pain.
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