Suture Techniques to Reduce the Incidence of The inCisional Hernia
STITCH
1 other identifier
interventional
576
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2009
Longer than P75 for not_applicable
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
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 26, 2010
CompletedFirst Posted
Study publicly available on registry
May 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedAugust 1, 2014
July 1, 2014
3.5 years
May 26, 2010
July 31, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incisional hernia occurrence within one year after operation clinical and/or radiographically detected
one year
Secondary Outcomes (1)
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).
one month
Study Arms (2)
Large tissue bites
ACTIVE COMPARATORAs 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.
small tissue bites
EXPERIMENTALIn 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.
Interventions
Closure of the midline incision after any abdominal operation. Suturing of the fascia of the abdominal wall with two different techniques
Eligibility Criteria
You may qualify if:
- Signed informed consent
- All laparotomies with a midline incision
- Age \> 18 years
You may not qualify if:
- Previous incisional hernia after midline incision
- Previous surgery through a midline incision within 3 months
- Pregnancy (in women)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Erasmus Medical Centerlead
- Sint Franciscus Gasthuiscollaborator
- Vlietland Ziekenhuiscollaborator
- Elisabeth-TweeSteden Ziekenhuiscollaborator
- Meander Medical Centercollaborator
- Kennemer Gasthuiscollaborator
- Rijnstate Hospitalcollaborator
- Groene Hart Ziekenhuiscollaborator
- Havenziekenhuiscollaborator
- Red Cross Hospital Beverwijkcollaborator
Study Sites (1)
Erasmus Medical Center
Rotterdam, South Holland, 3000CA, Netherlands
Related Publications (5)
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.
PMID: 19917943BACKGROUNDHarlaar 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.
PMID: 19285296BACKGROUNDMillbourn 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.
PMID: 13680306BACKGROUNDDeerenberg 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.
PMID: 26188742DERIVEDHarlaar 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.
PMID: 21871072DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Johan Lange, MD, PhD
Erasmus Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof dr JF Lange, professor of Surgery
Study Record Dates
First Submitted
May 26, 2010
First Posted
May 27, 2010
Study Start
October 1, 2009
Primary Completion
April 1, 2013
Study Completion
May 1, 2013
Last Updated
August 1, 2014
Record last verified: 2014-07