Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sint Franciscus Gasthuis | OTHER |
| Vlietland Ziekenhuis | OTHER |
| Elisabeth-TweeSteden Ziekenhuis | OTHER |
| Meander Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closure of the abdominal wall after midline incisions | Procedure | Closure of the midline incision after any abdominal operation. Suturing of the fascia of the abdominal wall with two different techniques |
| Measure | Description | Time Frame |
|---|---|---|
| Incisional hernia occurrence within one year after operation clinical and/or radiographically detected | one year |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | one month |
Not provided
Inclusion criteria
Exclusion criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johan Lange, MD, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Rotterdam | South Holland | 3000CA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19917943 | Background | 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. | |
| 19285296 | Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006547 | Hernia |
| D014946 | Wound Infection |
| D010146 | Pain |
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
| OTHER |
| Kennemer Gasthuis | OTHER |
| Rijnstate Hospital | OTHER |
| Groene Hart Ziekenhuis | OTHER |
| Havenziekenhuis | OTHER |
| Red Cross Hospital Beverwijk | OTHER |
Not provided
Not provided
Not provided
Not provided
| 13680306 | Background | 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. |
| 41920572 | Derived | van 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. |
| 26188742 | Derived | 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. |
| 21871072 | Derived | 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. |
| D012816 | Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |