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

Universitätsmedizin Mannheim

Status and phase: Terminated; Phase 3

Conditions: Colo-colonic Anastomoses; Ileo-colonic Anastomoses

Treatments: Procedure: Single-layer suture; Procedure: double layer-suture

Study type: Interventional

Funder types: Other

Identifiers

NCT00996554

EK II-MA 0263.5

Details and patient eligibility

About

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.

Enrollment: 252 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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252 participants in 2 patient groups

Double-Layer-Suture

Experimental group

Description:

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

Treatment:

Procedure: double layer-suture

Single-layer suture

Active Comparator group

Description:

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

Treatment:

Procedure: Single-layer suture