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

Aesculap

Status: Completed

Conditions: Injury of Abdominal Wall

Treatments: Device: Short Stitch; Device: Long stitch

Study type: Interventional

Funder types: Industry

Identifiers

NCT01965249

AAG-G-H-1308

Details and patient eligibility

About

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®).

Enrollment: 425 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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425 participants in 2 patient groups

Long stitch group

Active Comparator group

Description:

Long stitch suture technique Stitch interval = 10 mm; Lateral = 10 mm

Treatment:

Device: Long stitch

Short stitch group

Experimental group

Description:

Short stitch technique for AWC stitch interval = 5 mm; Lateral 5 - 8 mm

Treatment:

Device: Short Stitch