A prospective, randomised, controlled, double-blind phase I-II clinical trial on the safety of A-Part Gel as adhesion prophylaxis after major abdominal surgery versus non-treated group

Abstract

Background: Postoperative adhesions occur when fibrous strands of internal scar tissue bind anatomical structures to one another. The most common cause of intra-abdominal adhesions is previous intra-abdominal surgical intervention. Up to 74% of intestinal obstructions are caused by post surgical adhesions. Although a variety of methods and agents have been investigated to prevent post surgical adhesions, the problem of peritoneal adhesions remains largely unsolved. Materials serving as an adhesion barrier are much needed.

Methods/design: This is a prospective, randomised, controlled, patient blinded and observer blinded, single centre phase I-II trial, which evaluates the safety of A-Part Gel as an adhesion prophylaxis after major abdominal wall surgery, in comparison to an untreated control group. 60 patients undergoing an elective median laparotomy without prior abdominal surgery are randomly allocated into two groups of a 1:1- ratio. Safety parameter and primary endpoint of the study is the occurrence of wound healing impairment or peritonitis within 28 (+10) days after surgery. The frequency of anastomotic leakage within 28 days after operation, occurrence of adverse and serious adverse events during hospital stay up to 3 months and the rate of adhesions along the scar within 3 months are defined as secondary endpoints. After hospital discharge the investigator will examine the enrolled patients at 28 (+10) days and 3 months (+/-14 days) after surgery.

Discussion: This trial aims to assess, whether the intra-peritoneal application of A-Part Gel is safe and efficacious in the prevention of post-surgical adhesions after median laparotomy, in comparison to untreated controls.

Trial registration: ClinicalTrials.gov NCT00646412.

Figures

Figure 1

Flow chart of treatment schedule. (1) Daily documentation until day 7 has to be done in the patient chart. CRF documentation will be done on day 1, 4, ±1 and 7 + 1 after surgery. Adverse events have to be documented as soon as they occur. (2) Has to be done daily with respective documentation in the patient file. (3) CRF documentation will be done on these days. (4) Generally if the patient is discharged before day 7, all documentation required until the day of discharge (e.g. day 1, 4, etc.) has to be completed together with the discharge page (visit 3). However if discharge is on day 1, 4 + 1 or 7 + 1 the documentation of the respective day (day1, 4 or 7) can be omitted (with the exception of the header which has to be filled in); only the discharge page (visit 3) needs to be filled in instead.