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

Colo-colonic Anastomoses Clinical Trial

— ANATECH  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00996554
• Other study ID #: EK II-MA 0263.5
• Status: Terminated
• Phase: Phase 3
• First received: October 14, 2009
• Last updated: December 7, 2015
• Start date: January 2004
• Est. completion date: May 2012

Study information

• Verified date: December 2015
• Source: Universitätsmedizin Mannheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Committee Mannheim II
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 252
• Est. completion date: May 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colo-colonic Anastomoses
• Ileo-colonic Anastomoses

Intervention

Procedure:
• double layer-suture
Hand-sutured end-to-end or end-to-side anastomosis performed by double-layer continuous technique (monofil thread)
• Single-layer suture
Hand-sutured end-to-end or end-to-side anastomosis performed by single-layer continuous technique (monofil thread)

Locations

Country	Name	City	State
Germany	University Medical Center Mannheim, Surgical Department	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of clinical anastomostic leaks		3 months	Yes
Secondary	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	3 months	Yes
Secondary	postoperative morbidity		30 days	Yes
Secondary	Duration of anastomosis (min)		1-3 hours	No
Secondary	Frequency of anastomotic strictures		3 months	Yes