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

NCT ID: NCT00996554

Last Updated: 2015-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2012-05-31

Brief Summary

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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

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Conditions

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Colo-colonic Anastomoses Ileo-colonic Anastomoses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Single-layer suture

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

Group Type ACTIVE_COMPARATOR

Single-layer suture

Intervention Type PROCEDURE

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

Double-Layer-Suture

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

Group Type EXPERIMENTAL

double layer-suture

Intervention Type PROCEDURE

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

Interventions

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double layer-suture

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

Intervention Type PROCEDURE

Single-layer suture

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsmedizin Mannheim

OTHER

Sponsor Role lead

Responsible Party

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Prof Dr. Stefan Post

Prof. Dr. med., Director of Surgical Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan Post, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Mannheim, Germany, Surgical Department

Locations

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University Medical Center Mannheim, Surgical Department

Mannheim, , Germany

Site Status

Countries

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Germany

References

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Herrle F, Diener MK, Freudenberg S, Willeke F, Kienle P, Boenninghoff R, Weiss C, Partecke LI, Schuld J, Post S. Single-Layer Continuous Versus Double-Layer Continuous Suture in Colonic Anastomoses-a Randomized Multicentre Trial (ANATECH Trial). J Gastrointest Surg. 2016 Feb;20(2):421-30. doi: 10.1007/s11605-015-3003-0. Epub 2015 Nov 2.

Reference Type BACKGROUND
PMID: 26525206 (View on PubMed)

Other Identifiers

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EK II-MA 0263.5

Identifier Type: -

Identifier Source: org_study_id