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

July 19, 2023 updated by: Aesculap AG

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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

425

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 4021
        • AKH Linz
      • Wien, 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 1 year postoperatively
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
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
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
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
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
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days and 30 days postop
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
Time Frame: until 30 days postoperatively
Wound healing complications: Seroma, hematoma, necrosis, fistula
until 30 days postoperatively
Long Term Incisional hernia rate
Time Frame: 3 and 5 years postoperatively
assessment by ultrasound
3 and 5 years postoperatively
Long term Wound infections
Time Frame: 1 year postoperatively
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
Time Frame: until 1 year postoperatively
Wound healing complications: Seroma, hematoma, necrosis, fistula
until 1 year postoperatively
Costs
Time Frame: until 5 years postop
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
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
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
Time Frame: preop, 30 days postop, 1 year, 3 years, 5 years postop

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

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Collaborators

B.Braun Surgical SA

Investigators

  • Principal Investigator: Rene Fortelny, Dr., Wilhelminenspital Wien

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

December 15, 2019

Study Completion (Estimated)

December 1, 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 (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AAG-G-H-1308

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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