Colo-colonic AnastomosesPhase 3ANATECHNCT00996554
Randomized Study Comparing Two Established Gastrointestinal Suture Techniques - One-layer-continuous Versus Double-layer-continuous Suture
A Phase 3 study testing double layer-suture and Single-layer suture in people with Colo-colonic Anastomoses and Ileo-colonic Anastomoses, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-colonic Anastomoses, Ileo-colonic Anastomoses
- What is being tested?
- double layer-suture and Single-layer suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2004to May 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years old,
- planned for elective surgery
- at least one hand-sutured ileo-colonic or colo-colonic anastomosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Mannheim, Surgical Department
Mannheim, 68167
About this study
Official title: 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.
- Conditions
- Colo-colonic Anastomoses, Ileo-colonic Anastomoses
- Being tested
- double layer-suture, Single-layer suture
- Keywords
- Hand-sutured colo-colonic and ileo-colonic anastomoses in elective surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
double layer-sutureProcedure or surgery
Hand-sutured end-to-end or end-to-side anastomosis performed by double-layer continuous technique (monofil thread)
Single-layer sutureProcedure or surgery
Hand-sutured end-to-end or end-to-side anastomosis performed by single-layer continuous technique (monofil thread)
| Study group | Role | What they receive |
|---|---|---|
| Double-Layer-Suture | Experimental | Hand-sutured end-to-end or end-to-side anastomosis performed by double-layer continuous technique (monofil thread) Receives: Procedure: double layer-suture |
| Single-layer suture | Active comparator | Hand-sutured end-to-end or end-to-side anastomosis performed by single-layer continuous technique (monofil thread). Receives: Procedure: Single-layer suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of clinical anastomostic leaks
Measured: 3 months
Secondary outcomes (4)
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
Measured: 3 months
postoperative morbidity
Measured: 30 days
Duration of anastomosis (min)
Measured: 1-3 hours
Frequency of anastomotic strictures
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startJan 2004
- Primary completionJan 2012
- Study completionMay 2012
Why it stopped: Feasibility reasons; recruitment was too slow.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colo-colonic AnastomosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Dr. Stefan Post, Universitätsmedizin Mannheim
- Investigators
- Stefan Post, Prof, MD, Principal investigator, University Medical Center Mannheim, Germany, Surgical Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996554
- Sponsor's protocol ID
- EK II-MA 0263.5
- Acronym
- ANATECH
- Status last verified
- Dec 2015
- First submitted
- 14 Oct 2009
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Compare Two Gastrointestinal Anastomosis Techniques - Single Layer Continuous Versus Double Layer Continuous
- ClinicalTrials.gov ID
- NCT00996554
- Acronym / sponsor ID
- ANATECH / EK II-MA 0263.5
- Conditions
- Colo-colonic Anastomoses, Ileo-colonic Anastomoses
- Keywords
- Hand-sutured colo-colonic and ileo-colonic anastomoses in elective surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Feasibility reasons; recruitment was too slow.
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jan 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 16 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double-Layer-Suture | Experimental | Procedure: double layer-sutureHand-sutured end-to-end or end-to-side anastomosis performed by double-layer continuous technique (monofil thread) |
| Single-layer suture | Active comparator | Procedure: Single-layer sutureHand-sutured end-to-end or end-to-side anastomosis performed by single-layer continuous technique (monofil thread). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 18 years old,
- planned for elective surgery
- at least one hand-sutured ileo-colonic or colo-colonic anastomosis
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| double layer-sutureHand-sutured end-to-end or end-to-side anastomosis performed by double-layer continuous technique (monofil thread) | Procedure or surgery | Double-Layer-Suture |
| Single-layer sutureHand-sutured end-to-end or end-to-side anastomosis performed by single-layer continuous technique (monofil thread) | Procedure or surgery | Single-layer suture |
Primary outcome
Frequency of clinical anastomostic leaks
Time frame: 3 months
4 secondary outcomes
death of any cause within 3 months post-operatively
Time frame: 3 months
postoperative morbidity
Time frame: 30 days
Duration of anastomosis (min)
Time frame: 1-3 hours
Frequency of anastomotic strictures
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Feasibility reasons; recruitment was too slow.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
- Background: PubMed 26525206Herrle 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Post, Prof, MD principal investigator
University Medical Center Mannheim, Germany, Surgical Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing double layer-suture and Single-layer suture in people with Colo-colonic Anastomoses and Ileo-colonic Anastomoses, run by Universitätsmedizin Mannheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Feasibility reasons; recruitment was too slow.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of clinical anastomostic leaks (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00996554, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2015.