LaparotomyPhase 2/3CONTINTNCT00544583
Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy
A Phase 2/3 study testing Interrupted sutures and Continuous sutures in people with Laparotomy and Hernia, run by Heidelberg University at 1 site in Germany.
Trial summary
Patients undergoing primary midline laparotomy for an emergency surgical intervention with a suspected septic focus in the abdominal cavity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparotomy, Hernia
- What is being tested?
- Interrupted sutures and Continuous sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2007to Apr 2012
- Phase
- Phase 2/3
- 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
- Preoperative Inclusion criteria:
- Age equal or greater than 18 years
- Expected survival time more than 12 months
- Patients undergoing primary and emergency midline laparotomy (patients with prior laparoscopy (not colon resections) or minor abdominal operation (e.g. appendectomy, cholecystectomy, hysterectomy, sectio) may be included into the trial)
- Suspected septic abdominal focus (e.g. perforated stomach ulcer, perforated diverticulitis)
- Informed consent
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- Intraoperative inclusion criteria before closure:
- Successful source control
- Abdominal lavage
Who cannot join
- Preoperative exclusion criteria:
- Participation in another intervention-trial with interference of intervention and outcome of this study
- Intraoperative exclusion criteria before closure:
- Planned re-laparotomy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Surgery
Heidelberg, 69120
Nuh N Rahbari, MD, + 49 6221 56 39448, nuh.rahbari@med.uni-heidelberg.de
SDGC Heidelberg, +49 6221 56 6986, sdgc@med.uni-heidelberg.de
About this study
Official title: Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy: CONTINT - A Randomized Controlled Study
Patients undergoing primary midline laparotomy for an emergency surgical intervention with a suspected septic focus in the abdominal cavity.
Read the detailed description
More than 700.000 open abdominal surgeries (laparotomies) are performed each year in Germany (2). A major surgical complication after laparotomy is abdominal fascia dehiscence which might appear either as early (burst abdomen with evisceration) or as late complication (incisional hernia). These patients usually undergo surgery for secondary fascial closure associated with markedly increased morbidity (3) including high recurrence rates (up to 45%) (4). The applied surgical strategy of abdominal wall closure (i.e. the combination of suture technique and material) is of high relevance for prevention of fascia dehiscence and, moreover, constitutes the main factor directly controllable by the surgeon. While several randomized controlled trials (RCT) (3; 5-8) as well as meta-analyses (9-12) exist that address the issue of optimal fascia closure in elective laparotomies, there is no RCT dealing exclusively with the emergency setting. As a result abdominal fascia closure is performed according to the surgeon's individual preference rather than according to evidence-based data. Therefore, the present RCT is designed to compare the most established strategies (continuous slowly absorbable sutures and interrupted rapidly absorbable sutures) for abdominal wall closure in order to determine differences between both strategies after midline incisions.
- Conditions
- Laparotomy, Hernia
- Being tested
- Interrupted sutures, Continuous sutures
- Keywords
- Abdominal wall
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interrupted suturesProcedure or surgery
Interrupted sutures for abdominal fascia closure with Vicryl equivalent sutures (USP 2, 45 cm)
Continuous suturesProcedure or surgery
Continuous sutures for abdominal fascia closure with PDS II equivalent USP 1, 150 cm loops
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Interrupted closure with Vicryl equivalent sutures (USP 2, 45 cm) Receives: Procedure: Interrupted sutures |
| B | Experimental | Continuous closure with PDS II equivalent sutures (USP 1, 150 cm loops) Receives: Procedure: Continuous sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisional hernia or burst abdomen within 12 months
Measured: 12 months
Secondary outcomes (1)
Quality of Life
Measured: 12 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 2007 (estimated)
- Study startNov 2007
- Primary completionApr 2011 (estimated)
- Study completionApr 2012 (estimated)
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 LaparotomyStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Nuh N Rahbari, MD, Study director, Department of Surgery, University of HeidelbergMarkus W Büchler, MD, Principal investigator, Department of Surgery, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544583
- Sponsor's protocol ID
- S206/2007
- Acronym
- CONTINT
- Status last verified
- Jan 2010
- First submitted
- 15 Oct 2007
- Last updated
- 27 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rahbari NN, Knebel P, Kieser M, Bruckner T, Bartsch DK, Friess H, Mihaljevic AL, Stern J, Diener MK, Voss S, Rossion I, Buchler MW, Seiler CM. Design and current status of CONTINT: continuous versus interrupted abdominal wall closure after emergency midline laparotomy - a randomized controlled multicenter trial [NCT00544583]. Trials. 2012 May 30;13:72. doi: 10.1186/1745-6215-13-72.
PubMed 22647387
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy: CONTINT - A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00544583
- Acronym / sponsor ID
- CONTINT / S206/2007
- Conditions
- Laparotomy, Hernia
- Keywords
- Abdominal wall
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 16 Oct 2007 (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.
Patients undergoing primary midline laparotomy for an emergency surgical intervention with a suspected septic focus in the abdominal cavity.
Detailed description
More than 700.000 open abdominal surgeries (laparotomies) are performed each year in Germany (2). A major surgical complication after laparotomy is abdominal fascia dehiscence which might appear either as early (burst abdomen with evisceration) or as late complication (incisional hernia). These patients usually undergo surgery for secondary fascial closure associated with markedly increased morbidity (3) including high recurrence rates (up to 45%) (4). The applied surgical strategy of abdominal wall closure (i.e. the combination of suture technique and material) is of high relevance for prevention of fascia dehiscence and, moreover, constitutes the main factor directly controllable by the surgeon. While several randomized controlled trials (RCT) (3; 5-8) as well as meta-analyses (9-12) exist that address the issue of optimal fascia closure in elective laparotomies, there is no RCT dealing exclusively with the emergency setting. As a result abdominal fascia closure is performed according to the surgeon's individual preference rather than according to evidence-based data. Therefore, the present RCT is designed to compare the most established strategies (continuous slowly absorbable sutures and interrupted rapidly absorbable sutures) for abdominal wall closure in order to determine differences between both strategies after midline incisions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: Interrupted suturesInterrupted closure with Vicryl equivalent sutures (USP 2, 45 cm) |
| B | Experimental | Procedure: Continuous suturesContinuous closure with PDS II equivalent sutures (USP 1, 150 cm loops) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Preoperative Inclusion criteria:
- Intraoperative inclusion criteria before closure:
Key exclusion criteria (4 listed)
- Preoperative exclusion criteria:
- Intraoperative exclusion criteria before closure:
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 |
|---|---|---|
| Interrupted suturesInterrupted sutures for abdominal fascia closure with Vicryl equivalent sutures (USP 2, 45 cm) | Procedure or surgery | A |
| Continuous suturesContinuous sutures for abdominal fascia closure with PDS II equivalent USP 1, 150 cm loops | Procedure or surgery | B |
Primary outcome
Incisional hernia or burst abdomen within 12 months
Time frame: 12 months
1 secondary outcome
Quality of Life
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2010.
- Derived from this study: PubMed 22647387Rahbari NN, Knebel P, Kieser M, Bruckner T, Bartsch DK, Friess H, Mihaljevic AL, Stern J, Diener MK, Voss S, Rossion I, Buchler MW, Seiler CM. Design and current status of CONTINT: continuous versus interrupted abdominal wall closure after emergency midline laparotomy - a randomized controlled multicenter trial [NCT00544583]. Trials. 2012 May 30;13:72. doi: 10.1186/1745-6215-13-72.
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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.
Nuh N Rahbari, MD study director
Department of Surgery, University of Heidelberg
Markus W Büchler, MD principal investigator
Department of Surgery, University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Interrupted sutures and Continuous sutures in people with Laparotomy and Hernia, run by Heidelberg University 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 9 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Jan 2010. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nuh N Rahbari, MD (+49 6221 56 39448, nuh.rahbari@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incisional hernia or burst abdomen within 12 months (time frame: 12 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 NCT00544583, 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 27 Jan 2010.