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

Not Applicable

Completed

• Conditions: Injury of Abdominal Wall
• Interventions: Device: Long stitch; Device: Short Stitch

• Registration Number: NCT01965249
• Lead Sponsor: Aesculap AG

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®).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-09
• Study First Submitted QC: 2013-10-15
• Study First Posted: 2013-10-18
• Study Start: 2014-02
• Primary Completion: 2019-12-15
• Study Completion: 2024-12-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 425

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long stitch group	Long stitch	Long stitch suture technique Stitch interval = 10 mm; Lateral = 10 mm
Short stitch group	Short Stitch	Short stitch technique for AWC stitch interval = 5 mm; Lateral 5 - 8 mm

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Long Term Incisional hernia rate	3 and 5 years postoperatively	assessment by ultrasound
Frequency of burst abdomen	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
Length of postoperative hospital stay	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
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 infections are classified according to the US centres for disease control and prevention (CDC) as either deep or superficial.
Long Term Wound healing complications	until 1 year postoperatively	Wound healing complications: Seroma, hematoma, necrosis, fistula
Costs	until 5 years postop	Costs including material cost, cost per operation minute, cost per hospital stay, cost saving per incisional hernia.
Reoperation due to burst abdomen	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
Wound healing complications	until 30 days postoperatively	Wound healing complications: Seroma, hematoma, necrosis, fistula
Long term Wound infections	1 year postoperatively	Wound infections are classified according to the US centres for disease control and prevention (CDC) as either deep or superficial.
Course of Health status with EQ-5D Score	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.

Trial Locations

Locations (9)

AKH Linz; 🇦🇹 Linz, Austria

Vivantes Klinikum Spandau; 🇩🇪 Berlin, Germany

Städtisches Klinikum Braunschweig; 🇩🇪 Braunschweig, Germany

Klinikum der Johann-Wolfgang-Goethe Universität; 🇩🇪 Frankfurt, Germany

Klinik am Eichert, Allgemeinchirurgische Klinik; 🇩🇪 Göppingen, Germany

LMU Großhadern; 🇩🇪 München, Germany

Robert Bosch KH Stuttgart; 🇩🇪 Stuttgart, Germany

Klinikum Landkreis Tuttlingen, Klinik für Allgemein-, Viszeral, und Gefäßchirurgie; 🇩🇪 Tuttlingen, Germany

Wilhelminenspital Wien; 🇦🇹 Wien, Austria