Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy
CONTINT
1 other identifier
interventional
80
1 country
1
Brief Summary
Patients undergoing primary midline laparotomy for an emergency surgical intervention with a suspected septic focus in the abdominal cavity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2007
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2007
CompletedFirst Posted
Study publicly available on registry
October 16, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedJanuary 27, 2010
January 1, 2010
3.4 years
October 15, 2007
January 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incisional hernia or burst abdomen within 12 months
12 months
Secondary Outcomes (1)
Quality of Life
12 months
Study Arms (2)
A
ACTIVE COMPARATORInterrupted closure with Vicryl equivalent sutures (USP 2, 45 cm)
B
EXPERIMENTALContinuous closure with PDS II equivalent sutures (USP 1, 150 cm loops)
Interventions
Interrupted sutures for abdominal fascia closure with Vicryl equivalent sutures (USP 2, 45 cm)
Continuous sutures for abdominal fascia closure with PDS II equivalent USP 1, 150 cm loops
Eligibility Criteria
You may qualify if:
- 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
- Successful source control
- Abdominal lavage
You may not qualify if:
- Participation in another intervention-trial with interference of intervention and outcome of this study
- Planned re-laparotomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Surgery
Heidelberg, 69120, Germany
Related Publications (1)
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.
PMID: 22647387DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nuh N Rahbari, MD
Department of Surgery, University of Heidelberg
- PRINCIPAL INVESTIGATOR
Markus W Büchler, MD
Department of Surgery, University of Heidelberg
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 15, 2007
First Posted
October 16, 2007
Study Start
November 1, 2007
Primary Completion
April 1, 2011
Study Completion
April 1, 2012
Last Updated
January 27, 2010
Record last verified: 2010-01