Randomized Study Comparing Two Established Gastrointestinal Suture Techniques - One-layer-continuous Versus Double-layer-continuous Suture

Phase 3

Terminated

• Conditions: Ileo-colonic Anastomoses; Colo-colonic Anastomoses
• Interventions: Procedure: double layer-suture; Procedure: Single-layer suture

• Registration Number: NCT00996554
• Lead Sponsor: Universitätsmedizin Mannheim

Brief Summary

The purpose of this study is to examine the frequency of postoperative complications depending on the number of suture layers in colo-colonic and ileo-colonic anastomoses Hypothesis: double-layer suture has less anastomotic leakages compared to single-layer suture.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2009-10-14
• Study First Submitted QC: 2009-10-15
• Study First Posted: 2009-10-16
• Primary Completion: 2012-01
• Study Completion: 2012-05
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-07
• Last Update Posted: 2015-12-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

• at least 18 years old,
• planned for elective surgery
• at least one hand-sutured ileo-colonic or colo-colonic anastomosis

Exclusion Criteria

• ASA-Score > 3,
• missing written consent of the informed patient
• no existing choice between suture-techniques according to the surgeon
• patient not able to cooperate/non-compliance
• rectal anastomoses

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double-Layer-Suture	double layer-suture	Hand-sutured end-to-end or end-to-side anastomosis performed by double-layer continuous technique (monofil thread)
Single-layer suture	Single-layer suture	Hand-sutured end-to-end or end-to-side anastomosis performed by single-layer continuous technique (monofil thread).

Primary Outcome Measures

Name	Time	Method
Frequency of clinical anastomostic leaks	3 months

Secondary Outcome Measures

Name	Time	Method
postoperative morbidity	30 days
death of any cause within 3 months post-operatively	3 months	all causes of death will be recorded independently of a possible causal relationship with the operation
Duration of anastomosis (min)	1-3 hours
Frequency of anastomotic strictures	3 months

Trial Locations

Locations (1)

University Medical Center Mannheim, Surgical Department; 🇩🇪 Mannheim, Germany