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

Primary Purpose

Hernia, Wound Infection, Burst Abdomen

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Closure of the abdominal wall after midline incisions
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia focused on measuring surgery, incisional hernia, woundinfection, burst abdomen, pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Erasmus Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Large tissue bites

small tissue bites

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incisional hernia occurrence within one year after operation clinical and/or radiographically detected

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).

Full Information

First Posted
May 26, 2010
Last Updated
July 31, 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
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1. Study Identification

Unique Protocol Identification Number
NCT01132209
Brief Title
Suture Techniques to Reduce the Incidence of The inCisional Hernia
Acronym
STITCH
Official Title
Suture Techniques to Reduce the Incidence of The inCisional Hernia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Wound Infection, Burst Abdomen, Pain, Quality of Life
Keywords
surgery, incisional hernia, woundinfection, burst abdomen, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
576 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Large tissue bites
Arm Type
Active Comparator
Arm Description
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.
Arm Title
small tissue bites
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
Closure of the abdominal wall after midline incisions
Intervention Description
Closure of the midline incision after any abdominal operation. Suturing of the fascia of the abdominal wall with two different techniques
Primary Outcome Measure Information:
Title
Incisional hernia occurrence within one year after operation clinical and/or radiographically detected
Time Frame
one year
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Lange, MD, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus Medical Center
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3000CA
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
19917943
Citation
Millbourn D, Cengiz Y, Israelsson LA. Effect of stitch length on wound complications after closure of midline incisions: a randomized controlled trial. Arch Surg. 2009 Nov;144(11):1056-9. doi: 10.1001/archsurg.2009.189.
Results Reference
background
PubMed Identifier
19285296
Citation
Harlaar JJ, van Ramshorst GH, Nieuwenhuizen J, Ten Brinke JG, Hop WC, Kleinrensink GJ, Jeekel H, Lange JF. Small stitches with small suture distances increase laparotomy closure strength. Am J Surg. 2009 Sep;198(3):392-5. doi: 10.1016/j.amjsurg.2008.10.018. Epub 2009 Mar 12.
Results Reference
background
PubMed Identifier
13680306
Citation
Millbourn D, Israelsson LA. Wound complications and stitch length. Hernia. 2004 Feb;8(1):39-41. doi: 10.1007/s10029-003-0159-4. Epub 2003 Sep 6.
Results Reference
background
PubMed Identifier
26188742
Citation
Deerenberg EB, Harlaar JJ, Steyerberg EW, Lont HE, van Doorn HC, Heisterkamp J, Wijnhoven BP, Schouten WR, Cense HA, Stockmann HB, Berends FJ, Dijkhuizen FPH, Dwarkasing RS, Jairam AP, van Ramshorst GH, Kleinrensink GJ, Jeekel J, Lange JF. Small bites versus large bites for closure of abdominal midline incisions (STITCH): a double-blind, multicentre, randomised controlled trial. Lancet. 2015 Sep 26;386(10000):1254-1260. doi: 10.1016/S0140-6736(15)60459-7. Epub 2015 Jul 15.
Results Reference
derived
PubMed Identifier
21871072
Citation
Harlaar JJ, Deerenberg EB, van Ramshorst GH, Lont HE, van der Borst EC, Schouten WR, Heisterkamp J, van Doorn HC, Cense HA, Berends F, Stockmann HB, Vrijland WW, Consten EC, Ottow RT, Go PM, Hermans JJ, Steyerberg EW, Lange JF. A multicenter randomized controlled trial evaluating the effect of small stitches on the incidence of incisional hernia in midline incisions. BMC Surg. 2011 Aug 26;11:20. doi: 10.1186/1471-2482-11-20.
Results Reference
derived

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Suture Techniques to Reduce the Incidence of The inCisional Hernia

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