Effect of Stitch Technique on the Occurrence of Incisional Hernia After Abdominal Wall Closure
NCT ID: NCT01965249
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
425 participants
INTERVENTIONAL
2014-02-28
2024-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Long stitch group
Long stitch suture technique Stitch interval = 10 mm; Lateral = 10 mm
Long stitch
AWC with the long stitch technique using MonoMax USP 1, 150 cm loop, HR48 mm
Short stitch group
Short stitch technique for AWC stitch interval = 5 mm; Lateral 5 - 8 mm
Short Stitch
Short stitch suture technique using MonoMax USP 2/0, 150 cm, HR26 mm
Interventions
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Long stitch
AWC with the long stitch technique using MonoMax USP 1, 150 cm loop, HR48 mm
Short Stitch
Short stitch suture technique using MonoMax USP 2/0, 150 cm, HR26 mm
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing an elective, primary median laparotomy with an incision length of ≥ 15 cm
* Expected survival time longer than 1 year
* ASA I-III
* Written informed consent
Exclusion Criteria
* Patient undergoing surgery due to a pancreas carcinoma
* Patients who will be operated due to an abdominal aortic aneurysm
* Peritonitis
* Coagulopathy
* Current immunosuppressive therapy (more than 40 mg of a corticoid per day or azathioprin)
* Chemotherapy within the last 2 weeks before operation
* Radiotherapy of the abdomen within the last 6 weeks before operation
* Pregnant women (pregnancy test has to be performed)
* Severe neurologic and psychiatric disease
* Lack of compliance
18 Years
ALL
No
Sponsors
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B.Braun Surgical SA
INDUSTRY
Aesculap AG
INDUSTRY
Responsible Party
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Principal Investigators
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Rene Fortelny, Dr.
Role: PRINCIPAL_INVESTIGATOR
Wilhelminenspital Wien
Locations
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AKH Linz
Linz, , Austria
Wilhelminenspital Wien
Vienna, , Austria
Vivantes Klinikum Spandau
Berlin, , Germany
Städtisches Klinikum Braunschweig
Braunschweig, , Germany
Klinikum der Johann-Wolfgang-Goethe Universität
Frankfurt, , Germany
Klinik am Eichert, Allgemeinchirurgische Klinik
Göppingen, , Germany
LMU Großhadern
München, , Germany
Robert Bosch KH Stuttgart
Stuttgart, , Germany
Klinikum Landkreis Tuttlingen, Klinik für Allgemein-, Viszeral, und Gefäßchirurgie
Tuttlingen, , Germany
Countries
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References
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Albertsmeier M, Seiler CM, Fischer L, Baumann P, Husing J, Seidlmayer C, Franck A, Jauch KW, Knaebel HP, Buchler MW. Evaluation of the safety and efficacy of MonoMax(R) suture material for abdominal wall closure after primary midline laparotomy-a controlled prospective multicentre trial: ISSAAC [NCT005725079]. Langenbecks Arch Surg. 2012 Mar;397(3):363-71. doi: 10.1007/s00423-011-0884-6. Epub 2011 Dec 20.
Fischer L, Baumann P, Husing J, Seidlmayer C, Albertsmeier M, Franck A, Luntz S, Seiler CM, Knaebel HP. A historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety and efficacy of MonoMax suture material for abdominal wall closure after primary midline laparotomy. ISSAAC-Trial [NCT005725079]. BMC Surg. 2008 Jul 21;8:12. doi: 10.1186/1471-2482-8-12.
Fortelny RH, Baumann P, Thasler WE, Albertsmeier M, Riedl S, Steurer W, Kewer JL, Shamiyeh A. Effect of suture technique on the occurrence of incisional hernia after elective midline abdominal wall closure: study protocol for a randomized controlled trial. Trials. 2015 Feb 15;16:52. doi: 10.1186/s13063-015-0572-x.
Albertsmeier M, Hofmann A, Baumann P, Riedl S, Reisensohn C, Kewer JL, Hoelderle J, Shamiyeh A, Klugsberger B, Maier TD, Schumacher G, Kockerling F, Pession U, Weniger M, Fortelny RH. Effects of the short-stitch technique for midline abdominal closure: short-term results from the randomised-controlled ESTOIH trial. Hernia. 2022 Feb;26(1):87-95. doi: 10.1007/s10029-021-02410-y. Epub 2021 May 28.
Fortelny RH, Andrade D, Schirren M, Baumann P, Riedl S, Reisensohn C, Kewer JL, Hoelderle J, Shamiyeh A, Klugsberger B, Maier TD, Schumacher G, Kockerling F, Pession U, Hofmann A, Albertsmeier M. Effects of the short stitch technique for midline abdominal closure on incisional hernia (ESTOIH): randomized clinical trial. Br J Surg. 2022 Aug 16;109(9):839-845. doi: 10.1093/bjs/znac194.
Fortelny RH, Hofmann A, Baumann P, Riedl S, Kewer JL, Hoelderle J, Shamiyeh A, Klugsberger B, Maier TD, Schumacher G, Kockerling F, Pession U, Schirren M, Albertsmeier M. Three-year follow-up analysis of the short-stitch versus long-stitch technique for elective midline abdominal closure randomized-controlled (ESTOIH) trial. Hernia. 2024 Aug;28(4):1283-1291. doi: 10.1007/s10029-024-03025-9. Epub 2024 Mar 27.
Fortelny RH, Baumann P, Hofmann A, Riedl S, Kewer JL, Hoelderle J, Shamiyeh A, Klugsberger B, Maier TD, Schumacher G, Kockerling F, Woste G, Pession U, Albertsmeier M. 5-year clinical outcome of the ESTOIH trial comparing the short-bite versus large-bite technique for elective midline abdominal closure. Hernia. 2025 Aug 29;29(1):263. doi: 10.1007/s10029-025-03459-9.
Other Identifiers
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AAG-G-H-1308
Identifier Type: -
Identifier Source: org_study_id
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