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TerminatedNCT00996554ANATECHUpdated Dec 8, 2015

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

A Phase 3 interventional study of double layer-suture and Single-layer suture in Colo-colonic Anastomoses and Ileo-colonic Anastomoses, sponsored by Universitätsmedizin Mannheim. Terminated at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-08.

Sponsored by Universitätsmedizin Mannheim · Phase 3, Interventional, and Treatment

Why this study was terminated
Feasibility reasons; recruitment was too slow.
Phase
Phase 3
Study type
Interventional
Enrollment
252
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Colo-colonic Anastomoses
  • Ileo-colonic Anastomoses

Keywords

  • Hand-sutured colo-colonic and ileo-colonic anastomoses in elective surgery
03

In context

Lead sponsor

Universitätsmedizin Mannheim is the lead sponsor of 78 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • at least 18 years old,
  • planned for elective surgery
  • at least one hand-sutured ileo-colonic or colo-colonic anastomosis

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
252 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Proceduredouble layer-suture

    Hand-sutured end-to-end or end-to-side anastomosis performed by double-layer continuous technique (monofil thread)

  • ProcedureSingle-layer suture

    Hand-sutured end-to-end or end-to-side anastomosis performed by single-layer continuous technique (monofil thread)

06

What researchers measure

Primary outcomes

  1. Frequency of clinical anastomostic leaks

    Time frame: 3 months

Secondary outcomes

  1. death of any cause within 3 months post-operatively

    all causes of death will be recorded independently of a possible causal relationship with the operation

    Time frame: 3 months

  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

07

Study locations

1 site
  • University Medical Center Mannheim, Surgical Department
    Mannheim, 68167, Germany
08

References and documents

Publications

  • Herrle F, Diener MK, Freudenberg S, Willeke F, Kienle P, Boenninghoff R, Weiss C, Partecke LI, Schuld J, Post S. Single-Layer Continuous Versus Double-Layer Continuous Suture in Colonic Anastomoses-a Randomized Multicentre Trial (ANATECH Trial). J Gastrointest Surg. 2016 Feb;20(2):421-30. doi: 10.1007/s11605-015-3003-0. Epub 2015 Nov 2. PubMed 26525206 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2004, a primary completion of Jan 2012 and a completion of May 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 14, 2009
First posted
Oct 16, 2009
Start
Jan 2004
Primary completionActual
Jan 2012
CompletionActual
May 2012
Last update
Dec 8, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00996554
Lead sponsor
Universitätsmedizin Mannheim
Responsible party
Prof Dr. Stefan Post (Prof. Dr. med., Director of Surgical Department, Universitätsmedizin Mannheim) — Principal investigator
First posted
Oct 16, 2009
Start date
Jan 2004
Primary completion
Jan 2012
Completion
May 2012
Last update
Dec 8, 2015

Study contacts

Stefan Post, Prof, MD
principal investigator · University Medical Center Mannheim, Germany, Surgical Department

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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