Suture Techniques to Reduce the Incidence of The inCisional Hernia

Pain Clinical Trial

— STITCH  

Official title:

Suture Techniques to Reduce the Incidence of The inCisional Hernia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01132209
• Other study ID #: STITCH trial MEC 2009-026
• Status: Completed
• Phase: N/A
• First received: May 26, 2010
• Last updated: July 31, 2014
• Start date: October 2009
• Est. completion date: May 2013

Study information

• Verified date: July 2014
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 576
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

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

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam	Zuid-Holland

Sponsors (10)

Lead Sponsor	Collaborator
Erasmus Medical Center	Elisabeth-TweeSteden Ziekenhuis, Groene Hart Ziekenhuis, Havenziekenhuis, Kennemer Gasthuis, Meander Medical Center, Red Cross Hospital Beverwijk, Rijnstate Hospital, Sint Franciscus Gasthuis, Vlietland Ziekenhuis

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

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. — View 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. — View Citation

Millbourn D, Israelsson LA. Wound complications and stitch length. Hernia. 2004 Feb;8(1):39-41. Epub 2003 Sep 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incisional hernia occurrence within one year after operation clinical and/or radiographically detected		one year	No
Secondary	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	No