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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University Hospital Mannheim.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Mannheim
ClinicalTrials.gov Identifier:
NCT00996554
First received: October 14, 2009
Last updated: October 15, 2009
Last verified: October 2009
History of Changes
  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 University Hospital Mannheim:

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

Secondary Outcome Measures:
  • Mortality [ Time Frame: three months ] [ Designated as safety issue: Yes ]
  • 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: three months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 942
Study Start Date: January 2004
Estimated Primary Completion Date: June 2010 (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

Contacts
Contact: Florian Herrle, MD 0049-621-383 ext 2357 florian.herrle@umm.de
Contact: Peter Kienle, Prof., MD 0049-621-383 ext 2357 peter.kienle@umm.de

Locations
Germany
University Medical Center Mannheim, Surgical Department Recruiting
Mannheim, Germany, 68167
Sponsors and Collaborators
University Hospital 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, Director Surgical Department, University Medical Center 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: October 15, 2009
Health Authority: Germany: Ethics Committee Mannheim II

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

ClinicalTrials.gov processed this record on May 23, 2013