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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01965249
Acronym
ESTOIH
Enrollment
425
Registered
2013-10-18
Start date
2014-02-28
Completion date
2024-12-12
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injury of Abdominal Wall

Keywords

Laparotomy, short stitch, long stitch, MonoMax

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®).

Interventions

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

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

Sponsors

B.Braun Surgical SA
CollaboratorINDUSTRY
Aesculap AG
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incisional hernia rate1 year postoperativelyIncisional hernia rate 1 year postoperatively (assessment by ultrasound).

Secondary

MeasureTime frameDescription
Reoperation due to burst abdomenparticipants will be followed for the duration of hospital stay, an expected average of 10 daysBurst abdomen is defined as a clinically evident rupture of the laparotomy wound
Frequency of wound infectionsparticipants will be followed for the duration of hospital stay, an expected average of 10 days and 30 days postopWound infections are classified according to the US centres for disease control and prevention (CDC) as either deep or superficial.
Wound healing complicationsuntil 30 days postoperativelyWound healing complications: Seroma, hematoma, necrosis, fistula
Long Term Incisional hernia rate3 and 5 years postoperativelyassessment by ultrasound
Frequency of burst abdomenparticipants will be followed for the duration of hospital stay, an expected average of 10 daysBurst abdomen is defined as a clinically evident rupture of the laparotomy wound
Long Term Wound healing complicationsuntil 1 year postoperativelyWound healing complications: Seroma, hematoma, necrosis, fistula
Costsuntil 5 years postopCosts including material cost, cost per operation minute, cost per hospital stay, cost saving per incisional hernia.
Length of postoperative hospital stayparticipants will be followed for the duration of hospital stay, an expected average of 10 daysNumber of days the patient has to stay in hospital after the intervention
Course of Health status with EQ-5D Scorepreop, 30 days postop, 1 year, 3 years, 5 years postopThe 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.
Long term Wound infections1 year postoperativelyWound infections are classified according to the US centres for disease control and prevention (CDC) as either deep or superficial.

Countries

Austria, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026