A prospective, controlled, randomized, multi-center, pivotal study evaluating the safety and efficacy of ADHEXIL in prevention and/or reduction of adhesions in gynecology surgery

• Conditions: Adhesions in gynecology surgery. Surgeries involved will be ovarian cystectomy, endometriosis, inflammation, adhesiolysisOvarian adhesion MedDRA 10067156Tubal rupture MedDRA 10067553; MedDRA version: 9.1Level: LLTClassification code 10053865Term: Benign fallopian tube neoplasm; MedDRA version: 9.1Level: LLTClassification code 10064257Term: Ovarian fibroma; MedDRA version: 9.1Level: LLTClassification code 10052456Term: Parovarian cyst; MedDRA version: 9.1Level: LLTClassification code 10033139Term: Ovarian disorder; MedDRA version: 9.1Level: LLTClassification code 10033277Term: Ovarian prolapse; MedDRA version: 9.1Level: LLTClassification code 10050697Term: Fallopian tube cyst; MedDRA version: 9.1Level: LLTClassification code 10048991Term: Ovarian adenoma; MedDRA version: 9.1Level: LLTClassification code 10065741Term: Ovarian haemorrhage; MedDRA version: 9.1Level: LLTClassification code 10014778Term: Endometriosis

• Registration Number: EUCTR2009-010095-23-DE
• Lead Sponsor: Omrix Biopharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

1. Female patients aged 18-45 years at screening.
2. Patients scheduled for elective laparoscopic gynecology surgery involving at least one adnexa, due to ovarian cysts and/or endometriosis and/or prior inflammation and/or existing adhesions.
3.Patients must be willing to participate in the study, and provide written informed consent.
4.Patients must be available and willing to undertake study visits and procedures.
5.Patients of child-bearing potential must be using a medically acceptable method of birth control until the date of the 2LL.
6.Patient must have at least one adnexa (ovary and its adjacent tube

Intra-Operative Inclusion Criteria
1. Patient must have at least one adnexa (ovary and its adjacent tube)
2. Raw surface involving at least 1cm2 of adnexa surface prior to suturing/cautery.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Pregnant (including current ectopic pregnancy) or breastfeeding patient.
2.Patients whose 1LL procedure would involve surgical sterilization.
3.Patients whose 1LL procedure would involve hysterectomy.
4.Patients with a lymphatic, hematologic or coagulation disorder.
5.Patients with a known or suspected hypersensitivity to blood, blood products or any constituent of ADHEXIL™.
6.Patients whose pre-operative laboratory values at the baseline visit are out of normal ranges and are clinically significant, as classified by the investigator.
7.Patients who are immunocompromised, possess autoimmune disorders.
8.Patients who are routinely taking anticoagulants.
9.Patients who have participated in another clinical study within 30 days of enrolment.
10.Investigator’s opinion that the patient is medically unfit or would be at major risk if enrolled into the study.
11.Patients with American Society of Anesthesiologists class > 2 (see appendix B for classification).
12.Patients with a known or suspected hypersensitivity to Indigo Carmine
13.Patients diagnosed with adnexal cancer

Intra-Operative Exclusion Criteria
1. Presence of active infection.
2.Use of heparin-containing irrigants.
3.Use of other agents for the purpose of reducing adhesions, including corticosteroids, anticoagulants, and nonsteroidal anti-inflammatory agents.
4.Use of INTERCEED, SprayGel, Seprafilm, ADEPT, Hyskon, Oxiplex or any other adhesion reduction agent.
5.Patients whose 1LL procedure would involve enterotomy and/or cystotomy and/or urostomy, and/or postoperative hydrotubation.
6.Patients in whom a procedure required conversion to laparotomy.
7.Use of any topical hemostatic agents that are left behind in the body or use of catgut, chromic catgut, or nonresorbable sutures on the ovaries or tubes or immediately adjacent structures.
8.Use of gasless laparoscopy.
9.Performance of non-gynecologic surgical procedure (e.g. cholecystectomy).
10.Investigator’s opinion that a second look is not in the best interest of the patient.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to evaluate the safety and efficacy of ADHEXIL in preventing and/or reducing post-operative adhesions in patients undergoing gynecology surgery.;Secondary Objective: There are no secondary objectives for this trial.;Primary end point(s): The primary endpoint will be the AFS score of adhesion at the target adnexa at 2LL.