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

October 14, 2009
January 9, 2014
January 2004
January 2012   (final data collection date for primary outcome measure)
Frequency of clinical anastomostic leaks [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Frequency of clinical anastomostic leaks [ Time Frame: three months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00996554 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Randomized Study Comparing Two Established Gastrointestinal Suture Techniques - One-layer-continuous Versus Double-layer-continuous Suture
Randomized Trial to Compare Two Gastrointestinal Anastomosis Techniques - Single Layer Continuous Versus Double Layer Continuous

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
  • Colo-colonic Anastomoses
  • Ileo-colonic Anastomoses
  • Procedure: double layer-suture
    Hand-sutured end-to-end or end-to-side anastomosis performed by double-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)
  • Experimental: Double-Layer-Suture
    Hand-sutured end-to-end or end-to-side anastomosis performed by double-layer continuous technique (monofil thread)
    Intervention: Procedure: double layer-suture
  • Active Comparator: Single-layer suture
    Hand-sutured end-to-end or end-to-side anastomosis performed by single-layer continuous technique (monofil thread).
    Intervention: Procedure: Single-layer suture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
252
May 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00996554
EK II-MA 0263.5
Yes
Prof Dr. Stefan Post, University Hospital Mannheim
Universitätsmedizin Mannheim
Not Provided
Principal Investigator: Stefan Post, Prof, MD University Medical Center Mannheim, Germany, Surgical Department
Universitätsmedizin Mannheim
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP