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

This study has been completed.

Sponsor:

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

ClinicalTrials.gov Identifier:

NCT01132209

First received: May 26, 2010

Last updated: July 31, 2014

Last verified: July 2014

History of Changes

Purpose

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.

Condition	Intervention
Hernia Wound Infection Burst Abdomen Pain Quality of Life	Procedure: Closure of the abdominal wall after midline incisions


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Suture Techniques to Reduce the Incidence of The inCisional Hernia

Resource links provided by NLM:

MedlinePlus related topics: Hernia

U.S. FDA Resources

Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:

Incisional hernia occurrence within one year after operation clinical and/or radiographically detected [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]


Enrollment:	576
Study Start Date:	October 2009
Study Completion Date:	May 2013
Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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
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.	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

Arms

Assigned Interventions

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.

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

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.

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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01132209

Locations


Netherlands
Erasmus Medical Center
Rotterdam, Zuid-Holland, Netherlands, 3000CA

Sponsors and Collaborators

Erasmus Medical Center

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

More Information

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. Epub 2003 Sep 6.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Deerenberg EB, Harlaar JJ, Steyerberg EW, Lont HE, van Doorn HC, Heisterkamp J, Wijnhoven BP, Schouten WR, Cense HA, Stockmann HB, Berends FJ, Dijkhuizen FP, 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):1254-60. 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.


Responsible Party:	joris harlaar, Prof dr JF Lange, professor of Surgery, Erasmus Medical Center
ClinicalTrials.gov Identifier:	NCT01132209 History of Changes
Other Study ID Numbers:	STITCH trial MEC 2009-026
Study First Received:	May 26, 2010
Last Updated:	July 31, 2014
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Erasmus Medical Center:


surgery incisional hernia woundinfection burst abdomen pain

Additional relevant MeSH terms:


Hernia Wound Infection Incisional Hernia Pathological Conditions, Anatomical	Infection Wounds and Injuries Postoperative Complications Pathologic Processes

ClinicalTrials.gov processed this record on September 23, 2016

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