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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Sint Franciscus Gasthuis
Vlietland ziekenhuis
St. Elisabeth Hospital, Tilburg, Netherlands
Meander Medical Center
Kennemer Gasthuis
Rijnstate Hospital
Groene Hart Ziekenhuis
Havenziekenhuis
Rode Kruis Ziekenhuis
Information provided by (Responsible Party):
joris harlaar, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT01132209
First received: May 26, 2010
Last updated: March 7, 2012
Last verified: March 2012
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 ]

Estimated Enrollment: 576
Study Start Date: October 2009
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: March 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

  Eligibility

Ages Eligible for Study:   18 Years and older
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
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
St. Elisabeth Hospital, Tilburg, Netherlands
Meander Medical Center
Kennemer Gasthuis
Rijnstate Hospital
Groene Hart Ziekenhuis
Havenziekenhuis
Rode Kruis Ziekenhuis
Investigators
Principal Investigator: Johan Lange, MD, PhD Erasmus Medical Center
  More Information

Additional Information:
official study website  This link exits the ClinicalTrials.gov site

Publications:

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

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: March 7, 2012
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
Pathological Conditions, Anatomical
Infection
Wounds and Injuries

ClinicalTrials.gov processed this record on June 17, 2013