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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

Tracking Information
First Submitted Date  ICMJE May 26, 2010
First Posted Date  ICMJE May 27, 2010
Last Update Posted Date August 1, 2014
Study Start Date  ICMJE October 2009
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2010)
Incisional hernia occurrence within one year after operation clinical and/or radiographically detected [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2010)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Suture Techniques to Reduce the Incidence of The inCisional Hernia
Official Title  ICMJE Suture Techniques to Reduce the Incidence of The inCisional Hernia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Hernia
  • Wound Infection
  • Burst Abdomen
  • Pain
  • Quality of Life
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Closure of the abdominal wall after midline incisions
  • 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.
    Intervention: Procedure: Closure of the abdominal wall after midline incisions
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 2, 2011)
576
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2010)
550
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01132209
Other Study ID Numbers  ICMJE STITCH trial MEC 2009-026
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party joris harlaar, Erasmus Medical Center
Original Responsible Party Prof. dr. J.F. Lange, Erasmus Medical Center
Current Study Sponsor  ICMJE Erasmus Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Sint Franciscus Gasthuis
  • Vlietland Ziekenhuis
  • Elisabeth-TweeSteden Ziekenhuis
  • Meander Medical Center
  • Kennemer Gasthuis
  • Rijnstate Hospital
  • Groene Hart Ziekenhuis
  • Havenziekenhuis
  • Red Cross Hospital Beverwijk
Investigators  ICMJE
Principal Investigator: Johan Lange, MD, PhD Erasmus Medical Center
PRS Account Erasmus Medical Center
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP