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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01132209
Recruitment Status : Completed
First Posted : May 27, 2010
Last Update Posted : August 1, 2014
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hernia Wound Infection Burst Abdomen Pain Quality of Life Procedure: Closure of the abdominal wall after midline incisions Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 576 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Suture Techniques to Reduce the Incidence of The inCisional Hernia
Study Start Date : October 2009
Actual Primary Completion Date : April 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Incisional hernia occurrence within one year after operation clinical and/or radiographically detected [ Time Frame: one year ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01132209


Locations
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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
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Principal Investigator: Johan Lange, MD, PhD Erasmus Medical Center
More Information
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Publications:

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

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Responsible Party: joris harlaar, Prof dr JF Lange, professor of Surgery, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT01132209    
Other Study ID Numbers: STITCH trial MEC 2009-026
First Posted: May 27, 2010    Key Record Dates
Last Update Posted: August 1, 2014
Last Verified: July 2014
Keywords provided by joris harlaar, Erasmus Medical Center:
surgery
incisional hernia
woundinfection
burst abdomen
pain
Additional relevant MeSH terms:
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Wound Infection
Hernia
Incisional Hernia
Pathological Conditions, Anatomical
 Infections
Postoperative Complications
Pathologic Processes