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

Short Stitch Versus Long Stitch Suture Technique Using Monomax® for Abdominal Wall Closure After Primary Median Laparotomy. A Randomized, Controlled, Double-blinded, Multicenter, International Trial

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®).

Study Overview

• Status: Completed
• Conditions: Injury of Abdominal Wall
• Intervention / Treatment: Device: Long stitch; Device: Short Stitch

• Study Type: Interventional
• Enrollment (Actual): 425
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria, 4021
    • AKh Linz
  • Vienna, Austria, 1160
    • Wilhelminenspital Wien
• Germany
  • Berlin, Germany, 13585
    • Vivantes Klinikum Spandau
  • Braunschweig, Germany, 38126
    • Städtisches Klinikum Braunschweig
  • Frankfurt, Germany, 60590
    • Klinikum der Johann-Wolfgang-Goethe Universität
  • Göppingen, Germany, 73035
    • Klinik am Eichert, Allgemeinchirurgische Klinik
  • München, Germany, 81377
    • LMU Großhadern
  • Stuttgart, Germany, 70376
    • Robert Bosch KH Stuttgart
  • Tuttlingen, Germany, 78532
    • Klinikum Landkreis Tuttlingen, Klinik für Allgemein-, Viszeral, und Gefäßchirurgie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Long stitch group; Long stitch suture technique Stitch interval = 10 mm; Lateral = 10 mm	Device: Long stitch; AWC with the long stitch technique using MonoMax USP 1, 150 cm loop, HR48 mm
Experimental: Short stitch group; Short stitch technique for AWC stitch interval = 5 mm; Lateral 5 - 8 mm	Device: Short Stitch; Short stitch suture technique using MonoMax USP 2/0, 150 cm, HR26 mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incisional hernia rate	Incisional hernia rate 1 year postoperatively (assessment by ultrasound).	1 year postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of burst abdomen	Burst abdomen is defined as a clinically evident rupture of the laparotomy wound	participants will be followed for the duration of hospital stay, an expected average of 10 days
Reoperation due to burst abdomen	Burst abdomen is defined as a clinically evident rupture of the laparotomy wound	participants will be followed for the duration of hospital stay, an expected average of 10 days
Frequency of wound infections	Wound infections are classified according to the US centres for disease control and prevention (CDC) as either deep or superficial.	participants will be followed for the duration of hospital stay, an expected average of 10 days and 30 days postop
Wound healing complications	Wound healing complications: Seroma, hematoma, necrosis, fistula	until 30 days postoperatively
Long Term Incisional hernia rate	assessment by ultrasound	3 and 5 years postoperatively
Long term Wound infections	Wound infections are classified according to the US centres for disease control and prevention (CDC) as either deep or superficial.	1 year postoperatively
Long Term Wound healing complications	Wound healing complications: Seroma, hematoma, necrosis, fistula	until 1 year postoperatively
Costs	Costs including material cost, cost per operation minute, cost per hospital stay, cost saving per incisional hernia.	until 5 years postop
Length of postoperative hospital stay	Number of days the patient has to stay in hospital after the intervention	participants will be followed for the duration of hospital stay, an expected average of 10 days
Course of Health status with EQ-5D Score	The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Each answer results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions are combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.	preop, 30 days postop, 1 year, 3 years, 5 years postop

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: B.Braun Surgical SA
• Investigators: Principal Investigator: Rene Fortelny, Dr., Wilhelminenspital Wien

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): December 15, 2019
• Study Completion (Actual): December 12, 2024

Study Registration Dates

• First Submitted: October 9, 2013
• First Submitted That Met QC Criteria: October 15, 2013
• First Posted (Estimated): October 18, 2013

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Laparotomy; short stitch; long stitch; MonoMax
• Other Study ID Numbers: AAG-G-H-1308