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

This study has been terminated.
(Feasibility reasons; recruitment was too slow.)
Sponsor:
Information provided by (Responsible Party):
Prof Dr. Stefan Post, University Hospital Mannheim
ClinicalTrials.gov Identifier:
NCT00996554
First received: October 14, 2009
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Colo-colonic Anastomoses
Ileo-colonic Anastomoses
Procedure: double layer-suture
Procedure: Single-layer suture
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial to Compare Two Gastrointestinal Anastomosis Techniques - Single Layer Continuous Versus Double Layer Continuous

Further study details as provided by Universitätsmedizin Mannheim:

Primary Outcome Measures:
  • Frequency of clinical anastomostic leaks [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • death of any cause within 3 months post-operatively [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    all causes of death will be recorded independently of a possible causal relationship with the operation

  • postoperative morbidity [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Duration of anastomosis (min) [ Time Frame: 1-3 hours ] [ Designated as safety issue: No ]
  • Frequency of anastomotic strictures [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 252
Study Start Date: January 2004
Study Completion Date: May 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00996554

Locations
Germany
University Medical Center Mannheim, Surgical Department
Mannheim, Germany, 68167
Sponsors and Collaborators
Universitätsmedizin Mannheim
Investigators
Principal Investigator: Stefan Post, Prof, MD University Medical Center Mannheim, Germany, Surgical Department
  More Information

No publications provided

Responsible Party: Prof Dr. Stefan Post, Prof. Dr. med., Director of Surgical Department, University Hospital Mannheim
ClinicalTrials.gov Identifier: NCT00996554     History of Changes
Other Study ID Numbers: EK II-MA 0263.5
Study First Received: October 14, 2009
Last Updated: January 9, 2014
Health Authority: Germany: Ethics Committee Mannheim II

Keywords provided by Universitätsmedizin Mannheim:
Hand-sutured colo-colonic and ileo-colonic anastomoses in elective surgery

ClinicalTrials.gov processed this record on April 17, 2014