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

Phase 3TerminatedNCT00996554

Universitätsmedizin Mannheim252 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

252

Conditions

Colo-colonic Anastomoses Ileo-colonic Anastomoses

Interventions

double layer-suturePROCEDURE

Hand-sutured end-to-end or end-to-side anastomosis performed by double-layer continuous technique (monofil thread)

Single-layer suturePROCEDURE

Hand-sutured end-to-end or end-to-side anastomosis performed by single-layer continuous technique (monofil thread)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Medical Center Mannheim, Surgical Department

Mannheim, Germany

Outcomes

Primary Outcomes

Frequency of clinical anastomostic leaks

Time frame: 3 months

Secondary Outcomes

death of any cause within 3 months post-operatively

all causes of death will be recorded independently of a possible causal relationship with the operation

Time frame: 3 months

postoperative morbidity

Time frame: 30 days

Duration of anastomosis (min)

Time frame: 1-3 hours

Frequency of anastomotic strictures

Time frame: 3 months

Data from ClinicalTrials.gov

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