- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01262417
Resorbable Barrier for the Prevention of Abdominal and Peri-hepatic Adhesion Formation (SEPRAC2T)
Evaluationof the Efficiency of a Resorbable Barrier Membrane for the Prevention of Abdominal and Peri-hepatic Adhesion in Patients With Colorectal Cancer Requiring Two-stage Surgery for the Resection of Hepatic Metastases
The purpose of this study is to evaluate the efficiency of a resorbable barrier membrane for the prevention of abdominal and peri-hepatic adhesion in patients with colorectal cancer requiring two-stage surgery for the resection of hepatic metastases.
Eligible patients will be randomly assigned to one of 2 arms:
- Seprafilm group (receiving resorbable barrier membrane during the first surgery)
- No-treatment control group (without seprafilm barrier during the first surgery)
The primary objective is to establish, in patients with colorectal cancer requiring two-stage surgery for the resection of hepatic metastases, the efficiency of a resorbable barrier membrane (Seprafilm) for limiting abdominal and peri-hepatic adhesion during the second operation.
This study is a prospective multicentric phase II, controlled, randomized and non comparative trial.
A total of 60 patients will be enrolled: 45 will receive Seprafilm whereas 15 will be assigned to the no-treatment control group. The inclusion period should be approximately 18 months. The follow up period after the second surgery will be 3 years.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The secondary objectives of the study are:
During and after the 1st surgical procedure To evaluate immediate complications (during surgery), early complications (during post-surgery hospitalization) and late complications (between 1st and 2nd surgeries) in relation with operating procedure and use of resorbable membrane.
During and after the 2nd surgical procedure
- To evaluate abdominal and peri-hepatic adhesion (at the site of the 1st surgery), with qualitative and quantitative description.
- To evaluate intestinal adhesion (in the small intestine), with quantitative description.
- To evaluate immediate complications (during surgery), early complications (during post-surgery hospitalization) and late complications (in the month following the intervention) in relation with operating procedure.
- To evaluate post-operative rehabilitation
- To assess tumour evolution in patients over a period of 3 years after the 2nd surgery.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Bordeaux, France, 33076
- Institut Bergonié
-
Clamart, France
- Hôpital Antoine Béclère
-
Clermont Ferrand, France
- CHU Clermont Ferrand
-
Clichy, France
- Hopital Beaujon
-
Grenoble, France
- CHU Grenoble
-
Lyon, France
- Centre Leon Berard
-
Lyon, France
- Hopital de La Croix Rousse
-
Lyon, France
- Centre Hospitalier Lyon Sud
-
Marseille, France
- Institut Paoli Calmettes
-
Marseille, France
- CHU la Conception
-
Montpellier, France
- Centre Val d'Aurelle Paul Lamarque
-
Nancy, France
- Centre Alexis Vautrin
-
Nancy, France
- Hôpital de Brabois CHU
-
Nice, France
- CHU Nice-Hôpital de l'Archet II
-
Paris, France
- Hopital Cochin
-
Rouen, France
- Hôpital Charles Nicolle - CHU Rouen
-
Villejuif, France
- Institut Gustave Roussy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women and men aged ≥ 18 years
- Colorectal cancer with synchronous or metachronous hepatic metastases
- Patients requiring two-stage surgery with laparotomy for the resection of hepatic metastases
- The 2 operations should be scheduled in the same centre
- The 2 operations should be scheduled at an interval of 1 to 6 months
- Patient affiliated with social security
- Patient able to read and write French
- Written, voluntary, informed consent
Exclusion Criteria:
- Patient with previous hepatic or biliary surgery through supra-umbilical incision (except biliary surgery with laparotomy more than 6 months previously)
- Patient with previous major surgery except colorectal surgery for resection of primitive tumour
- Metastasis removable in one surgical procedure
- Non resectable metastasis
- Follow-up impossible for social, geographical, familial or psychological reasons
- Patient deprived of freedom
- Patient enrolled in another experimental surgery trial
- Pregnant or lactating woman
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: - Seprafilm group
patients receiving resorbable barrier membrane during the first surgery
|
use of resorbable membrane during the first surgery for the resection of hepatic metastases, 1 to 4 membranes should be used around the liver
Other Names:
|
Other: - No-treatment control group
patients without seprafilm barrier during the first surgery
|
non use of resorbable membrane during the first surgery for the resection of hepatic metastases
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
abdominal and peri-hepatic adhesion during the second operation
Time Frame: Time to liberate liver (t0: incision and t1: liberation)
|
Time to liberate liver (t0: incision and t1: liberation)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
immediate complications during the first surgical procedure in relation with operating procedure and use of resorbable membrane
Time Frame: during the surgery
|
during the surgery
|
early complications (after the 1st surgical procedure)in relation with operating procedure and use of resorbable membrane
Time Frame: during post-surgery hospitalization
|
during post-surgery hospitalization
|
late complications (after the 1st surgical procedure)in relation with operating procedure and use of resorbable membrane
Time Frame: between 1st and 2nd surgeries (2 operations should be scheduled at an interval of 1 to 6 months)
|
between 1st and 2nd surgeries (2 operations should be scheduled at an interval of 1 to 6 months)
|
abdominal and peri-hepatic adhesion (at the site of the 1st surgery), with qualitative and quantitative description
Time Frame: at the beginning of the 2nd surgical procedure
|
at the beginning of the 2nd surgical procedure
|
intestinal adhesion (in the small intestine), with quantitative description
Time Frame: at the beginning of the second surgical procedure
|
at the beginning of the second surgical procedure
|
immediate complications in relation with operating procedure.
Time Frame: during the 2nd surgical procedure
|
during the 2nd surgical procedure
|
early complications (after 2ng operation) in relation with operating procedure.
Time Frame: during post-surgery hospitalization
|
during post-surgery hospitalization
|
late complications in relation with operating procedure.
Time Frame: in the month following the 2nd intervention
|
in the month following the 2nd intervention
|
post-operative rehabilitation
Time Frame: during post-surgery hospitalization
|
during post-surgery hospitalization
|
tumour evolution in patients
Time Frame: over a period of 3 years after the 2nd surgery
|
over a period of 3 years after the 2nd surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michel Rivoire, MD, Centre Léon Bérard, Lyon
Publications and helpful links
General Publications
- Jaeck D, Oussoultzoglou E, Rosso E, Greget M, Weber JC, Bachellier P. A two-stage hepatectomy procedure combined with portal vein embolization to achieve curative resection for initially unresectable multiple and bilobar colorectal liver metastases. Ann Surg. 2004 Dec;240(6):1037-49; discussion 1049-51. doi: 10.1097/01.sla.0000145965.86383.89.
- Weibel MA, Majno G. Peritoneal adhesions and their relation to abdominal surgery. A postmortem study. Am J Surg. 1973 Sep;126(3):345-53. doi: 10.1016/s0002-9610(73)80123-0. No abstract available.
- Adam R, Laurent A, Azoulay D, Castaing D, Bismuth H. Two-stage hepatectomy: A planned strategy to treat irresectable liver tumors. Ann Surg. 2000 Dec;232(6):777-85. doi: 10.1097/00000658-200012000-00006.
- Ellis H, Moran BJ, Thompson JN, Parker MC, Wilson MS, Menzies D, McGuire A, Lower AM, Hawthorn RJ, O'Brien F, Buchan S, Crowe AM. Adhesion-related hospital readmissions after abdominal and pelvic surgery: a retrospective cohort study. Lancet. 1999 May 1;353(9163):1476-80. doi: 10.1016/S0140-6736(98)09337-4.
- Beck DE, Opelka FG, Bailey HR, Rauh SM, Pashos CL. Incidence of small-bowel obstruction and adhesiolysis after open colorectal and general surgery. Dis Colon Rectum. 1999 Feb;42(2):241-8. doi: 10.1007/BF02237135. Erratum In: Dis Colon Rectum 1999 May;42(5):578.
- Diamond MP, Freeman ML. Clinical implications of postsurgical adhesions. Hum Reprod Update. 2001 Nov-Dec;7(6):567-76. doi: 10.1093/humupd/7.6.567.
- Ray NF, Denton WG, Thamer M, Henderson SC, Perry S. Abdominal adhesiolysis: inpatient care and expenditures in the United States in 1994. J Am Coll Surg. 1998 Jan;186(1):1-9. doi: 10.1016/s1072-7515(97)00127-0.
- Lower AM, Hawthorn RJ, Ellis H, O'Brien F, Buchan S, Crowe AM. The impact of adhesions on hospital readmissions over ten years after 8849 open gynaecological operations: an assessment from the Surgical and Clinical Adhesions Research Study. BJOG. 2000 Jul;107(7):855-62. doi: 10.1111/j.1471-0528.2000.tb11083.x.
- Lower AM, Hawthorn RJ, Clark D, Boyd JH, Finlayson AR, Knight AD, Crowe AM; Surgical and Clinical Research (SCAR) Group. Adhesion-related readmissions following gynaecological laparoscopy or laparotomy in Scotland: an epidemiological study of 24 046 patients. Hum Reprod. 2004 Aug;19(8):1877-85. doi: 10.1093/humrep/deh321. Epub 2004 Jun 3.
- Parker MC, Ellis H, Moran BJ, Thompson JN, Wilson MS, Menzies D, McGuire A, Lower AM, Hawthorn RJ, O'Briena F, Buchan S, Crowe AM. Postoperative adhesions: ten-year follow-up of 12,584 patients undergoing lower abdominal surgery. Dis Colon Rectum. 2001 Jun;44(6):822-29; discussion 829-30. doi: 10.1007/BF02234701.
- Parker MC. Epidemiology of adhesions: the burden. Hosp Med. 2004 Jun;65(6):330-6. doi: 10.12968/hosp.2004.65.6.13729.
- Bristow RE, Montz FJ. Prevention of adhesion formation after radical oophorectomy using a sodium hyaluronate-carboxymethylcellulose (HA-CMC) barrier. Gynecol Oncol. 2005 Nov;99(2):301-8. doi: 10.1016/j.ygyno.2005.06.057. Epub 2005 Aug 8.
- Bristow RE, Santillan A, Diaz-Montes TP, Gardner GJ, Giuntoli RL 2nd, Peeler ST. Prevention of adhesion formation after radical hysterectomy using a sodium hyaluronate-carboxymethylcellulose (HA-CMC) barrier: a cost-effectiveness analysis. Gynecol Oncol. 2007 Mar;104(3):739-46. doi: 10.1016/j.ygyno.2006.09.029. Epub 2006 Nov 13.
- Duron JJ. [Post-operative bowel obstruction. Part 2: Mechanical post-operative small bowel obstruction by bands and adhesions]. J Chir (Paris). 2003 Dec;140(6):325-34. French.
- Duron JJ. [Post-operative bowel obstruction. Part 1: Intraperitoneal bands and adhesions--causes and prevention]. J Chir (Paris). 2003 Sep;140(4):211-9. French.
- Cuervas-Mons V, Rimola A, Van Thiel DH, Gavaler JS, Schade RR, Starzl TE. Does previous abdominal surgery alter the outcome of pediatric patients subjected to orthotopic liver transplantation? Gastroenterology. 1986 Apr;90(4):853-7. doi: 10.1016/0016-5085(86)90860-7.
- Sandler AD, Azarow KS, Superina RA. The impact of a previous Kasai procedure on liver transplantation for biliary atresia. J Pediatr Surg. 1997 Mar;32(3):416-9. doi: 10.1016/s0022-3468(97)90594-7.
- Ong TH. Prevention of intraabdominal adhesions in Kasai portoenterostomy. J Pediatr Surg. 2001 Nov;36(11):1613-4. doi: 10.1053/jpsu.2001.27930.
- Jaeck D, Bachellier P, Guiguet M, Boudjema K, Vaillant JC, Balladur P, Nordlinger B. Long-term survival following resection of colorectal hepatic metastases. Association Francaise de Chirurgie. Br J Surg. 1997 Jul;84(7):977-80. doi: 10.1002/bjs.1800840719.
- Rivoire M; ANAES. [Can initially non-respectable hepatic metastases be made resectable?]. Gastroenterol Clin Biol. 2003 Mar;27 Spec No 2:B18-9, B88-104. No abstract available. French.
- Al-Jaroudi D, Tulandi T. Adhesion prevention in gynecologic surgery. Obstet Gynecol Surv. 2004 May;59(5):360-7. doi: 10.1097/00006254-200405000-00024.
- Beck DE, Cohen Z, Fleshman JW, Kaufman HS, van Goor H, Wolff BG; Adhesion Study Group Steering Committee. A prospective, randomized, multicenter, controlled study of the safety of Seprafilm adhesion barrier in abdominopelvic surgery of the intestine. Dis Colon Rectum. 2003 Oct;46(10):1310-9. doi: 10.1007/s10350-004-6739-2.
- Becker JM, Dayton MT, Fazio VW, Beck DE, Stryker SJ, Wexner SD, Wolff BG, Roberts PL, Smith LE, Sweeney SA, Moore M. Prevention of postoperative abdominal adhesions by a sodium hyaluronate-based bioresorbable membrane: a prospective, randomized, double-blind multicenter study. J Am Coll Surg. 1996 Oct;183(4):297-306.
- Diamond MP. Reduction of adhesions after uterine myomectomy by Seprafilm membrane (HAL-F): a blinded, prospective, randomized, multicenter clinical study. Seprafilm Adhesion Study Group. Fertil Steril. 1996 Dec;66(6):904-10.
- Salum MR, Lam DT, Wexner SD, Pikarsky A, Baig MK, Weiss EG, Nogueras JJ, Singh JJ. Does limited placement of bioresorbable membrane of modified sodium hyaluronate and carboxymethylcellulose (Seprafilm) have possible short-term beneficial impact? Dis Colon Rectum. 2001 May;44(5):706-12. doi: 10.1007/BF02234571.
- Tang CL, Seow-Choen F, Fook-Chong S, Eu KW. Bioresorbable adhesion barrier facilitates early closure of the defunctioning ileostomy after rectal excision: a prospective, randomized trial. Dis Colon Rectum. 2003 Sep;46(9):1200-7. doi: 10.1007/s10350-004-6716-9.
- Vrijland WW, Tseng LN, Eijkman HJ, Hop WC, Jakimowicz JJ, Leguit P, Stassen LP, Swank DJ, Haverlag R, Bonjer HJ, Jeekel H. Fewer intraperitoneal adhesions with use of hyaluronic acid-carboxymethylcellulose membrane: a randomized clinical trial. Ann Surg. 2002 Feb;235(2):193-9. doi: 10.1097/00000658-200202000-00006.
- Tingstedt B, Isaksson K, Andersson E, Andersson R. Prevention of abdominal adhesions--present state and what's beyond the horizon? Eur Surg Res. 2007;39(5):259-68. doi: 10.1159/000102591. Epub 2007 May 10.
- Oikonomakis I, Wexner SD, Gervaz P, You SY, Secic M, Giamundo P. Seprafilm: a retrospective preliminary evaluation of the impact on short-term oncologic outcome in colorectal cancer. Dis Colon Rectum. 2002 Oct;45(10):1376-80. doi: 10.1007/s10350-004-6428-1.
- Kusunoki M, Ikeuchi H, Yanagi H, Noda M, Tonouchi H, Mohri Y, Uchida K, Inoue Y, Kobayashi M, Miki C, Yamamura T. Bioresorbable hyaluronate-carboxymethylcellulose membrane (Seprafilm) in surgery for rectal carcinoma: a prospective randomized clinical trial. Surg Today. 2005;35(11):940-5. doi: 10.1007/s00595-005-3061-0.
- Wieand HS. Randomized phase II trials: what does randomization gain? J Clin Oncol. 2005 Mar 20;23(9):1794-5. doi: 10.1200/JCO.2005.10.956. Epub 2005 Feb 7. No abstract available.
- Dixon WJ, Massey FJ. Introduction to statistical analysis. 4th Edition McGraw-Hill, 1983; 80-5.
- Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53: 457-81.
- Dupre A, Lefranc A, Buc E, Delpero JR, Quenet F, Passot G, Evrard S, Rivoire M. Use of bioresorbable membranes to reduce abdominal and perihepatic adhesions in 2-stage hepatectomy of liver metastases from colorectal cancer: results of a prospective, randomized controlled phase II trial. Ann Surg. 2013 Jul;258(1):30-6. doi: 10.1097/SLA.0b013e3182854949.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Fibrosis
- Cicatrix
- Colorectal Neoplasms
- Tissue Adhesions
- Physiological Effects of Drugs
- Immunologic Factors
- Protective Agents
- Adjuvants, Immunologic
- Viscosupplements
- Hyaluronic Acid
Other Study ID Numbers
- SEPRAC2T
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