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

December 7, 2015 updated by: Prof Dr. Stefan Post, Universitätsmedizin Mannheim

Randomized Trial to Compare Two Gastrointestinal Anastomosis Techniques - Single Layer Continuous Versus Double Layer Continuous

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

252

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mannheim, Germany, 68167
        • University Medical Center Mannheim, Surgical Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Double-Layer-Suture
Hand-sutured end-to-end or end-to-side anastomosis performed by double-layer continuous technique (monofil thread)
Procedure: double layer-suture
Hand-sutured end-to-end or end-to-side anastomosis performed by double-layer continuous technique (monofil thread)
Active Comparator: Single-layer suture
Hand-sutured end-to-end or end-to-side anastomosis performed by single-layer continuous technique (monofil thread).
Procedure: Single-layer suture
Hand-sutured end-to-end or end-to-side anastomosis performed by single-layer continuous technique (monofil thread)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of clinical anastomostic leaks
Time Frame: 3 months
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsmedizin Mannheim

Investigators

  • Principal Investigator: Stefan Post, Prof, MD, University Medical Center Mannheim, Germany, Surgical Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

October 14, 2009

First Submitted That Met QC Criteria

October 15, 2009

First Posted (Estimate)

October 16, 2009

Study Record Updates

Last Update Posted (Estimate)

December 8, 2015

Last Update Submitted That Met QC Criteria

December 7, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EK II-MA 0263.5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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