A Randomized Multi-centre Study to Assess the Safety and Manageability of a Laparoscopic Adhesion Barrier in Women Undergoing Gynecologic Laparoscopic Surgery Followed by Second Look Laparoscopy — LABS-1  

Tissue Adhesions Clinical Trial

Official title: A Randomized, Controlled, Subject and Reviewer-Blinded, Multi-Centre Study To Assess The Safety and Manageability Of LABS™ In Women Undergoing Gynaecologic Laparoscopic Surgery Followed By Second Look Laparoscopy

Status Completed

Clinical Trial Summary

The purpose of this study is to obtain data on the safety and manageability of applying LABS™ to the uterus and other areas of surgical trauma in the pelvis and abdomen following laparoscopic gynaecologic surgery. In addition, performance data following a clinical indicated second look laparoscopy will be collected for the purpose of determining sample size predictions for future trials.

Clinical Trial Description

Women undergoing laparoscopic uterine myomectomy, adhesiolysis, treatment of endometriosis or ovarian cystectomy with associated adhesions and/or endometriosis, and planned, clinically indicated second look laparoscopy within 4-12 weeks will be enrolled into one of two sub studies in which the major component of the surgery (as determined by the surgeon) was due to:

1. Myomectomy Or

2. Other Gynaecology Pathology (repeat myomectomy, adhesiolysis, and/or treatment of endometriosis, ovarian cystectomy with associated adhesions or endometriotic pathology, removal of adenomyoma without myomectomy.

The myomectomy sub study will include two arms:

1. Pure Myomectomy -myomectomy with no endometriosis and no adhesions/few filmy uterine adhesions - blunt dissection only

2. Hybrid Myomectomy - myomectomy with (+/-) adhesions and/or (+/-) endometriosis and/or (+/-) adenomyomectomy Patients in each sub study (1 or 2) and each arm of the myomectomy study (a or b) will be randomized to receive LABS™ following their laparoscopic surgery or current standard of care: surgery only control. All patients will be blinded to their treatment status until study completion.

Sub study and sub-group allocation as well as randomisation will occur once the initial laparoscopy is completed but before removal of the laparoscope. Myomectomy patients randomized to receive LABS™ will then have the device sprayed to the entire surface of the uterus and other areas of surgical trauma. In all treated patients all sites of surgical trauma should be completely covered with LABS™ allowing a sprayed margin of at least 3 cm around the operated or traumatised site.

Patients receiving LABS™ will be compared to patients who have had the current standard of care: surgery alone. In addition to an overall comparison, they will be compared to patients in the same sub study (1 or 2) and same arm of the myomectomy study (1a or 1b).

The first two patients entered by each operating surgeon will be allocated to LABS™ and assessed for the application of LABS™. They will not be counted as fully evaluable randomized patients. These patients will be sequentially assigned and evaluated. With confirmatory evaluation of and application of LABS™ on the first patient, the surgeon will be advised to assign the second. With the same confirmatory evaluation on the second patient and both patients discharged from hospital the surgeon will be permitted to proceed with the study and randomise patients.

Both the initial laparoscopic procedure and the clinically indicated second look laparoscopy will be video recorded to allow for a blinded evaluation of LABS™ application and a separate blinded evaluation of adhesions and other pathology in all patients - treated and controls. This evaluation will be cross checked with the operating surgeon's own evaluations and reconciled according to a specified protocol.

Where, during initial surgery, a second look laparoscopy is no longer considered clinically indicated but the surgeon randomizes the patient, they will be followed for safety evaluations only. ;

Related Conditions & MeSH terms

• Tissue Adhesions

• NCT number: NCT02260115
• Study type: Interventional
• Source: Actamax Surgical Materials LLC
• Status: Completed
• Phase: Phase 1
• Start date: November 2013
• Completion date: July 2016