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Injury of Abdominal WallESTOIHNCT01965249

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

A study testing Long stitch and Short Stitch in people with Injury of Abdominal Wall, run by Aesculap AG at 9 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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%. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Injury of Abdominal Wall
What is being tested?
Long stitch and Short Stitch
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
425 participants
Where
9 sitesin 2 countries
Study dates
Feb 2014to 12 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

Germany7 sites

  • Vivantes Klinikum Spandau

    Berlin, 13585

  • Städtisches Klinikum Braunschweig

    Braunschweig, 38126

  • Klinikum der Johann-Wolfgang-Goethe Universität

    Frankfurt, 60590

  • Klinik am Eichert, Allgemeinchirurgische Klinik

    Göppingen, 73035

  • LMU Großhadern

    München, 81377

  • Robert Bosch KH Stuttgart

    Stuttgart, 70376

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

    Tuttlingen, 78532

Other trials in Germany

Austria2 sites

  • AKH Linz

    Linz, 4021

  • Wilhelminenspital Wien

    Vienna, 1160

Other trials in Austria

About this study

Official title: 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®).

Being tested
Long stitch, Short Stitch
Keywords
Laparotomy, short stitch, long stitch, MonoMax

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Long stitchDevice

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

  • Short StitchDevice

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

Study groups in NCT01965249
Study groupRoleWhat they receive
Long stitch groupActive comparatorLong stitch suture technique Stitch interval = 10 mm; Lateral = 10 mm
Receives: Device: Long stitch
Short stitch groupExperimentalShort stitch technique for AWC stitch interval = 5 mm; Lateral 5 - 8 mm
Receives: Device: Short Stitch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incisional hernia rate

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

    Measured: 1 year postoperatively

Secondary outcomes (10)

  1. Frequency of burst abdomen

    Burst abdomen is defined as a clinically evident rupture of the laparotomy wound

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

  2. Reoperation due to burst abdomen

    Burst abdomen is defined as a clinically evident rupture of the laparotomy wound

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

  3. Frequency of wound infections

    Wound infections are classified according to the US centres for disease control and prevention (CDC) as either deep or superficial.

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

  4. Wound healing complications

    Wound healing complications: Seroma, hematoma, necrosis, fistula

    Measured: until 30 days postoperatively

  5. Long Term Incisional hernia rate

    assessment by ultrasound

    Measured: 3 and 5 years postoperatively

  6. Long term Wound infections

    Wound infections are classified according to the US centres for disease control and prevention (CDC) as either deep or superficial.

    Measured: 1 year postoperatively

  7. Long Term Wound healing complications

    Wound healing complications: Seroma, hematoma, necrosis, fistula

    Measured: until 1 year postoperatively

  8. Costs

    Costs including material cost, cost per operation minute, cost per hospital stay, cost saving per incisional hernia.

    Measured: until 5 years postop

  9. Length of postoperative hospital stay

    Number of days the patient has to stay in hospital after the intervention

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

  10. 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.

    Measured: preop, 30 days postop, 1 year, 3 years, 5 years postop

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2013 (estimated)
  2. Study startFeb 2014
  3. Primary completion15 Dec 2019
  4. Study completion12 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
425 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01965249
Sponsor's protocol ID
AAG-G-H-1308
Acronym
ESTOIH
Status last verified
Sep 2025
First submitted
9 Oct 2013
Last updated
8 Sep 2025
Results posted
No
Data monitoring committee
No

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.

    PubMed 22183105

  • 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.

    PubMed 18644124

  • 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.

    PubMed 25887884

  • 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.

    PubMed 34050419

  • 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.

    PubMed 35707932

  • 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.

    PubMed 38536592

  • 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.

    PubMed 40879826

Questions about this trial

What is this clinical trial studying?

A study testing Long stitch and Short Stitch in people with Injury of Abdominal Wall, run by Aesculap AG at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incisional hernia rate (time frame: 1 year postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01965249, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.

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