Effect of Stitch Technique on the Occurrence of Incisional Hernia After Abdominal Wall Closure

NCT01965249 | Completed

• 1 other identifier: AAG-G-H-1308
• Study Type: interventional
• Target: 425
• Locations: 2 countries
• Sites: 9

Brief Summary

The major long term complication of abdominal wall closure after a median laparotomy is the development of an incisional hernia. Several suture technique and suture material have been used but the incidence of this complication still lies between 9 -20%. Synthetic suture material which have become available over the last decades have the advantage that they are degraded by the body system and fully absorbed within 70-180 days; however they loss 50% of their initial strength already after 14-30 days and may not be the optimal suture material for abdominal wall closure. A new suture material (Monomax®) was developed with an extra-long absorption profile, high elasticity and with a superior initial strength. Therefore, the ESTOIH-Study was designed to investigate the influence of the stitch length on the occurrence of incisional hernia using the extra-long term absorbable, elastic, monofilament suture (Monomax®).

Conditions

Injury of Abdominal Wall

Keywords

Laparotomy; short stitch; long stitch; MonoMax

Outcome Measures

Primary Outcomes (1)

• Incisional hernia rate

  Incisional hernia rate 1 year postoperatively (assessment by ultrasound).

  1 year postoperatively

Secondary Outcomes (10)

• Frequency of burst abdomen

  participants will be followed for the duration of hospital stay, an expected average of 10 days

• Reoperation due to burst abdomen

  participants will be followed for the duration of hospital stay, an expected average of 10 days

• Frequency of wound infections

  participants will be followed for the duration of hospital stay, an expected average of 10 days and 30 days postop

• Wound healing complications

  until 30 days postoperatively

• Long Term Incisional hernia rate

  3 and 5 years postoperatively

Study Arms (2)

Long stitch group

ACTIVE COMPARATOR

Long stitch suture technique Stitch interval = 10 mm; Lateral = 10 mm

Device: Long stitch

Short stitch group

EXPERIMENTAL

Short stitch technique for AWC stitch interval = 5 mm; Lateral 5 - 8 mm

Device: Short Stitch

Interventions

Long stitch DEVICE

AWC with the long stitch technique using MonoMax USP 1, 150 cm loop, HR48 mm

Long stitch group

Short Stitch DEVICE

Short stitch suture technique using MonoMax USP 2/0, 150 cm, HR26 mm

Short stitch group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• 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

You may not qualify if:

• Emergency surgery
• 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

Sponsors & Collaborators

• Aesculap AG: lead
• B.Braun Surgical SA: collaborator

Study Sites (9)

AKH Linz

Linz, 4021, Austria

Location

Wilhelminenspital Wien

Vienna, 1160, Austria

Location

Vivantes Klinikum Spandau

Berlin, 13585, Germany

Location

Städtisches Klinikum Braunschweig

Braunschweig, 38126, Germany

Location

Klinikum der Johann-Wolfgang-Goethe Universität

Frankfurt, 60590, Germany

Location

Klinik am Eichert, Allgemeinchirurgische Klinik

Göppingen, 73035, Germany

Location

LMU Großhadern

München, 81377, Germany

Location

Robert Bosch KH Stuttgart

Stuttgart, 70376, Germany

Location

Klinikum Landkreis Tuttlingen, Klinik für Allgemein-, Viszeral, und Gefäßchirurgie

Tuttlingen, 78532, Germany

Location

Related Publications (7)

• 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.

  PMID: 22183105 BACKGROUND

• 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.

  PMID: 18644124 BACKGROUND

• 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.

  PMID: 25887884 BACKGROUND

• 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.

  PMID: 34050419 RESULT

• 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.

  PMID: 35707932 RESULT

• 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.

  PMID: 38536592 RESULT

• 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.

  PMID: 40879826 RESULT

Study Officials

• Rene Fortelny, Dr.

  Wilhelminenspital Wien

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 18, 2013
• Study Start: February 1, 2014
• Primary Completion: December 15, 2019
• Study Completion: December 12, 2024
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

AU (2); DE (7)