HerniaSTITCHNCT01132209
Suture Techniques to Reduce the Incidence of The inCisional Hernia
A study testing Closure of the abdominal wall after midline incisions in people with Hernia and Wound Infection, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Wound Infection, Burst Abdomen
- What is being tested?
- Closure of the abdominal wall after midline incisions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 576 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2009to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- All laparotomies with a midline incision
- Age > 18 years
Who cannot join
- Previous incisional hernia after midline incision
- Previous surgery through a midline incision within 3 months
- Pregnancy (in women)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hernia, Wound Infection, Burst Abdomen, Pain, Quality of Life
- Being tested
- Closure of the abdominal wall after midline incisions
- Keywords
- surgery, incisional hernia, woundinfection, burst abdomen, pain
- Medical subject headings
- Hernia, Wound Infection, Pain, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closure of the abdominal wall after midline incisionsProcedure or surgery
Closure of the midline incision after any abdominal operation. Suturing of the fascia of the abdominal wall with two different techniques
| Study group | Role | What they receive |
|---|---|---|
| Large tissue bites | Active comparator | 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. Receives: Procedure: Closure of the abdominal wall after midline incisions |
| small tissue bites | Experimental | 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. Receives: Procedure: Closure of the abdominal wall after midline incisions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisional hernia occurrence within one year after operation clinical and/or radiographically detected
Measured: one year
Secondary outcomes (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).
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startOct 2009
- Primary completionApr 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HerniaStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 576 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sint Franciscus Gasthuis, Vlietland Ziekenhuis, Elisabeth-TweeSteden Ziekenhuis, Meander Medical Center, Kennemer Gasthuis, Rijnstate Hospital, Groene Hart Ziekenhuis, Havenziekenhuis, Red Cross Hospital Beverwijk
- Responsible party
- Principal investigator, joris harlaar, Erasmus Medical Center
- Investigators
- Johan Lange, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132209
- Sponsor's protocol ID
- STITCH trial MEC 2009-026
- Acronym
- STITCH
- Status last verified
- Jul 2014
- First submitted
- 26 May 2010
- Last updated
- 1 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19917943Harlaar 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.
PubMed 19285296Millbourn 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.
PubMed 13680306van den Berg R, van Egmond S, Smits F, Baart SJ, Aufenacker TJ, Cense HA, Consten ECJ, Dijkhuizen FPHLJ, van Doorn HLC, Harlaar JJ, Kleinrensink GJ, Lange JF, Lont HE, Poelman MM, Stockmann HBAC, Theeuwes HP, Tanis PJ, Deerenberg EB. Small Bites vs Large Bites for Closure of Abdominal Midline Incisions: A Randomized Clinical Trial. JAMA Surg. 2026 Jun 1;161(6):566-573. doi: 10.1001/jamasurg.2026.0618.
PubMed 41920572Deerenberg 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.
PubMed 26188742Harlaar 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.
PubMed 21871072
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suture Techniques to Reduce the Incidence of The inCisional Hernia
- ClinicalTrials.gov ID
- NCT01132209
- Acronym / sponsor ID
- STITCH / STITCH trial MEC 2009-026
- Conditions
- Hernia, Wound Infection, Burst Abdomen, Pain, Quality of Life
- Keywords
- surgery, incisional hernia, woundinfection, burst abdomen, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 576 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Sint Franciscus Gasthuis, Vlietland Ziekenhuis, Elisabeth-TweeSteden Ziekenhuis, Meander Medical Center, Kennemer Gasthuis, Rijnstate Hospital, Groene Hart Ziekenhuis, Havenziekenhuis, Red Cross Hospital Beverwijk
- Study start
- Oct 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 27 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Large tissue bites | Active comparator | Procedure: Closure of the abdominal wall after midline incisionsAs 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. |
| small tissue bites | Experimental | Procedure: Closure of the abdominal wall after midline incisionsIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent
- All laparotomies with a midline incision
- Age > 18 years
Key exclusion criteria (3 listed)
- Previous incisional hernia after midline incision
- Previous surgery through a midline incision within 3 months
- Pregnancy (in women)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closure of the abdominal wall after midline incisionsClosure of the midline incision after any abdominal operation. Suturing of the fascia of the abdominal wall with two different techniques | Procedure or surgery | Large tissue bites, small tissue bites |
Primary outcome
Incisional hernia occurrence within one year after operation clinical and/or radiographically detected
Time frame: one year
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2014.
- Background: PubMed 19917943Millbourn 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.
- Background: PubMed 19285296Harlaar 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.
- Background: PubMed 13680306Millbourn 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.
- Derived from this study: PubMed 41920572van den Berg R, van Egmond S, Smits F, Baart SJ, Aufenacker TJ, Cense HA, Consten ECJ, Dijkhuizen FPHLJ, van Doorn HLC, Harlaar JJ, Kleinrensink GJ, Lange JF, Lont HE, Poelman MM, Stockmann HBAC, Theeuwes HP, Tanis PJ, Deerenberg EB. Small Bites vs Large Bites for Closure of Abdominal Midline Incisions: A Randomized Clinical Trial. JAMA Surg. 2026 Jun 1;161(6):566-573. doi: 10.1001/jamasurg.2026.0618.
- Derived from this study: PubMed 26188742Deerenberg 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.
- Derived from this study: PubMed 21871072Harlaar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Lange, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closure of the abdominal wall after midline incisions in people with Hernia and Wound Infection, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incisional hernia occurrence within one year after operation clinical and/or radiographically detected (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01132209, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2014.