- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01132209
Suture Techniques to Reduce the Incidence of The inCisional Hernia (STITCH)
July 31, 2014 updated by: joris harlaar, Erasmus Medical Center
The objective of the study is reduction of the incidence of the most frequent complication of abdominal surgery, incisional hernia.
In this multi center double-blinded prospective randomized controlled trial, in which a new suture technique using small bites is compared with the traditionally applied large bites (mass closure) technique for midline incisions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
576
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zuid-Holland
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Rotterdam, Zuid-Holland, Netherlands, 3000CA
- Erasmus Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria
- Signed informed consent
- All laparotomies with a midline incision
- Age > 18 years
Exclusion criteria
- Previous incisional hernia after midline incision
- Previous surgery through a midline incision within 3 months
- Pregnancy (in women)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Large tissue bites
As control the conventional large bites technique (mass closure) will be applied in with bites widths of 1 cm and inter-suture spacing of 1 cm with the use of PDS plus ll 1-0 double loop suture material with a 48 mm needle.
|
Closure of the midline incision after any abdominal operation.
Suturing of the fascia of the abdominal wall with two different techniques
|
Experimental: small tissue bites
In the other group of 288 patients the small bites technique will be applied with bite widths of 0,5 cm and inter suture spacing of 0,5 cm with the use of PDS plus ll 2-0 single suture material with a 31 mm needle placed in the linea alba.
In the small bites technique, twice as many stitches will be placed per sutured cm, with a smaller needle and thinner suture material.
|
Closure of the midline incision after any abdominal operation.
Suturing of the fascia of the abdominal wall with two different techniques
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incisional hernia occurrence within one year after operation clinical and/or radiographically detected
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
postoperative complications; in particular wound infection (during admission), burst abdomen (during admission) and wound pain (measured with a visual analog scale (VAS) during the first 6 days after surgery).
Time Frame: one month
|
one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Johan Lange, MD, PhD, Erasmus Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Millbourn D, Cengiz Y, Israelsson LA. Effect of stitch length on wound complications after closure of midline incisions: a randomized controlled trial. Arch Surg. 2009 Nov;144(11):1056-9. doi: 10.1001/archsurg.2009.189.
- Harlaar JJ, van Ramshorst GH, Nieuwenhuizen J, Ten Brinke JG, Hop WC, Kleinrensink GJ, Jeekel H, Lange JF. Small stitches with small suture distances increase laparotomy closure strength. Am J Surg. 2009 Sep;198(3):392-5. doi: 10.1016/j.amjsurg.2008.10.018. Epub 2009 Mar 12.
- Millbourn D, Israelsson LA. Wound complications and stitch length. Hernia. 2004 Feb;8(1):39-41. doi: 10.1007/s10029-003-0159-4. Epub 2003 Sep 6.
- Deerenberg EB, Harlaar JJ, Steyerberg EW, Lont HE, van Doorn HC, Heisterkamp J, Wijnhoven BP, Schouten WR, Cense HA, Stockmann HB, Berends FJ, Dijkhuizen FPH, Dwarkasing RS, Jairam AP, van Ramshorst GH, Kleinrensink GJ, Jeekel J, Lange JF. Small bites versus large bites for closure of abdominal midline incisions (STITCH): a double-blind, multicentre, randomised controlled trial. Lancet. 2015 Sep 26;386(10000):1254-1260. doi: 10.1016/S0140-6736(15)60459-7. Epub 2015 Jul 15.
- Harlaar JJ, Deerenberg EB, van Ramshorst GH, Lont HE, van der Borst EC, Schouten WR, Heisterkamp J, van Doorn HC, Cense HA, Berends F, Stockmann HB, Vrijland WW, Consten EC, Ottow RT, Go PM, Hermans JJ, Steyerberg EW, Lange JF. A multicenter randomized controlled trial evaluating the effect of small stitches on the incidence of incisional hernia in midline incisions. BMC Surg. 2011 Aug 26;11:20. doi: 10.1186/1471-2482-11-20.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
May 26, 2010
First Submitted That Met QC Criteria
May 26, 2010
First Posted (Estimate)
May 27, 2010
Study Record Updates
Last Update Posted (Estimate)
August 1, 2014
Last Update Submitted That Met QC Criteria
July 31, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STITCH trial MEC 2009-026
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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