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:
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
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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 |
| 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 |
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 ]
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| 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)
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
| 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 |
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 |
| 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:
|
Hernia Wound Infection Incisional Hernia Pathological Conditions, Anatomical |
Infection Postoperative Complications Pathologic Processes |