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

N/ACompletedNCT01965249

Aesculap AG425 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

425

Conditions

Injury of Abdominal Wall

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

AKH Linz

Linz, Austria

Wilhelminenspital Wien

Vienna, 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

Outcomes

Primary Outcomes

Incisional hernia rate

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

Time frame: 1 year postoperatively

Secondary Outcomes

Frequency of burst abdomen

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

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: until 30 days postoperatively

Long Term Incisional hernia rate

assessment by ultrasound

Time frame: 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.

Time frame: 1 year postoperatively

Long Term Wound healing complications

Wound healing complications: Seroma, hematoma, necrosis, fistula

Time frame: until 1 year postoperatively

Costs

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

Time frame: until 5 years postop

Length of postoperative hospital stay

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

Time frame: 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.

Time frame: preop, 30 days postop, 1 year, 3 years, 5 years postop