Clinical trial NCT01132209: Suture Techniques to Reduce the Incidence of The inCisional Hernia
Official title: Suture Techniques to Reduce the Incidence of The inCisional Hernia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia
Wound Infection
Burst Abdomen
Pain
Quality of Life
Keywords: surgery
incisional hernia
woundinfection
burst abdomen
pain
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Sint Franciscus Gasthuis
name: Vlietland Ziekenhuis
name: Elisabeth-TweeSteden Ziekenhuis
name: Meander Medical Center
name: Kennemer Gasthuis
name: Rijnstate Hospital
name: Groene Hart Ziekenhuis
name: Havenziekenhuis
name: Red Cross Hospital Beverwijk
First posted: 2010-05-27
Enrollment: 576
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Incisional hernia occurrence within one year after operation clinical and/or radiographically detected
timeFrame: one year
Secondary outcomes:
measure: 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).
timeFrame: one month
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Johan Lange, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.