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Suture Techniques to Reduce the Incidence of The inCisional Hernia (STITCH)
This study has been completed.
Sponsor:
Erasmus Medical Center
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
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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 Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | Suture Techniques to Reduce the Incidence of The inCisional Hernia |
Resource links provided by NLM:
Further study details as provided by joris harlaar, Erasmus Medical Center:
Primary Outcome Measures:
- Incisional hernia occurrence within one year after operation clinical and/or radiographically detected [ Time Frame: one year ]
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 ]
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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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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
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
Additional Information:
Publications:
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: | July 31, 2014 |
Keywords provided by joris harlaar, 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 21, 2017