Clinical Use of an Absorbable Coated Suture Material in Surgery (Safil)

Phase 4

Completed

• Conditions: Laparotomy; Gastrointestinal Diseases; Anastomosis, Surgical; Absorbable, Coated Sutures
• Interventions: Procedure: Gastrointestinal Anastomosis

• Registration Number: NCT00645684
• Lead Sponsor: Aesculap AG

Brief Summary

The purpose is to test a coated polyglycolic acid multifilament suture in gastrointestinal surgery as part of a controlled randomized single blinded parallel group trial. The applicability and safety of the strand material used in two suture techniques (2-layer suture technique vs. 1-layer running) are to be tested on the basis of handling characteristics, the operative time consumed for the construction of the 1st anastomosis, the average time of the hospital duration for both patient groups, and the frequency of postoperative complications after discharge, 1 month and a maximum of 3-4 months. The used suture units are counted and the length of sutures determined which will be an indirect measurement of the costs of suture material for the two techniques.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-04
• Primary Completion: 2001-09
• Study Completion: 2002-05
• Status Verified: 2008-03
• Study First Submitted: 2008-03-25
• Study First Submitted QC: 2008-03-25
• Last Update Submitted: 2008-03-25
• Study First Posted: 2008-03-28
• Last Update Posted: 2008-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Patients of both sexes, undergoing a gastrointestinal hand made one-layer running (A) or two-layer (B) anastomotic procedure where the use of synthetic absorbable surgical suture material is indicated.
• Written consent to participate in the study

Exclusion Criteria

• Emergency patients that cannot be properly informed about the clinical trial and cannot give their written consent
• Pregnancy or lactation period
• Patients suffering from a diffuse purulent peritonitis or generalized diseases, which can have consequences for the healing of the asnastomosis (e.g. ubalanced diabetes, progressed uremia, massive hypoproteinaemia, sever jaundice, generalized intraabdominal tumor metastases, severe tumorous cachexia, severe avitaminosis, chronic liver disease.
• Patients who are undergoing a therapeutic procedure, which can have consequences for the healing of the anastomosis (e.g. treatment with corticosteroids or cytostatics, local radiation in the operating area)
• Laparoscopial Procedures
• Patients who are not willing to cooperate and legally incapacitated people

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Gastrointestinal Anastomosis	one layer running suture technique
B	Gastrointestinal Anastomosis	two-layer suture technique

Primary Outcome Measures

Name	Time	Method
Frequency of postoperative Complications	discharge, 1 month and a maximum of 3-4 months

Secondary Outcome Measures

Name	Time	Method
Operation time to construct the first anastomosis	intraoperative
length of hospitalization	postoperative
costs of suture material	intraoperative
handling characteristics	intraoperative

Trial Locations

Locations (3)

Bugat Pal Korhaz, Sebeszeti Osztaly; 🇭🇺 Gyöngyös, Hungary

Medical School of University Pecs; 🇭🇺 Pecs, Hungary

B.-A.-Z. Megyei Korhaz, Sebeszeti Osztaly; 🇭🇺 Miskolc, Hungary