Suture Techniques to Reduce the Incidence of The inCisional Hernia (STITCH)

• ClinicalTrials.gov Identifier: NCT01132209
• Recruitment Status: Completed
• First Posted: May 27, 2010
• Last Update Posted: August 1, 2014
• Sponsor: Erasmus Medical Center
• Collaborators: Sint Franciscus Gasthuis; Vlietland Ziekenhuis; Elisabeth-TweeSteden Ziekenhuis; Meander Medical Center; Kennemer Gasthuis; Rijnstate Hospital; Groene Hart Ziekenhuis; Havenziekenhuis; Red Cross Hospital Beverwijk
• Information provided by (Responsible Party): joris harlaar, Erasmus Medical Center

Tracking Information

• First Submitted Date: May 26, 2010
• First Posted Date: May 27, 2010
• Last Update Posted Date: August 1, 2014
• Study Start Date: October 2009
• Actual Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 26, 2010): Incisional hernia occurrence within one year after operation clinical and/or radiographically detected [ Time Frame: one year ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: May 26, 2010): 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 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Suture Techniques to Reduce the Incidence of The inCisional Hernia
• Official Title: Suture Techniques to Reduce the Incidence of The inCisional Hernia
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Hernia
• Wound Infection
• Burst Abdomen
• Pain
• Quality of Life

Intervention

Procedure: Closure of the abdominal wall after midline incisions

Closure of the midline incision after any abdominal operation. Suturing of the fascia of the abdominal wall with two different techniques

Study Arms

• 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.
  Intervention: Procedure: Closure of the abdominal wall after midline incisions
• 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.
  Intervention: Procedure: Closure of the abdominal wall after midline incisions

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 2, 2011): 576
• Original Estimated Enrollment (submitted: May 26, 2010): 550
• Actual Study Completion Date: May 2013
• Actual Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT01132209
• Other Study ID Numbers: STITCH trial MEC 2009-026
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: joris harlaar, Erasmus Medical Center
• Original Responsible Party: Prof. dr. J.F. Lange, Erasmus Medical Center
• Current Study Sponsor: Erasmus Medical Center
• Original Study Sponsor: Same as current

Collaborators

• Sint Franciscus Gasthuis
• Vlietland Ziekenhuis
• Elisabeth-TweeSteden Ziekenhuis
• Meander Medical Center
• Kennemer Gasthuis
• Rijnstate Hospital
• Groene Hart Ziekenhuis
• Havenziekenhuis
• Red Cross Hospital Beverwijk

Investigators

• Principal Investigator: Johan Lange, MD, PhD; Erasmus Medical Center

• PRS Account: Erasmus Medical Center
• Verification Date: July 2014