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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014