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

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ClinicalTrials.gov Identifier: NCT00996554
Recruitment Status : Terminated (Feasibility reasons; recruitment was too slow.)
First Posted : October 16, 2009
Last Update Posted : December 8, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Colo-colonic Anastomoses Ileo-colonic Anastomoses Procedure: double layer-suture Procedure: Single-layer suture Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial to Compare Two Gastrointestinal Anastomosis Techniques - Single Layer Continuous Versus Double Layer Continuous
Study Start Date : January 2004
Primary Completion Date : January 2012
Study Completion Date : May 2012
Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. Frequency of clinical anastomostic leaks [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. death of any cause within 3 months post-operatively [ Time Frame: 3 months ]
    all causes of death will be recorded independently of a possible causal relationship with the operation

  2. postoperative morbidity [ Time Frame: 30 days ]
  3. Duration of anastomosis (min) [ Time Frame: 1-3 hours ]
  4. Frequency of anastomotic strictures [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Prof Dr. Stefan Post, Prof. Dr. med., Director of Surgical Department, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT00996554     History of Changes
Other Study ID Numbers: EK II-MA 0263.5
First Posted: October 16, 2009    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015

Keywords provided by Prof Dr. Stefan Post, Universitätsmedizin Mannheim:
Hand-sutured colo-colonic and ileo-colonic anastomoses in elective surgery