Clinical trial NCT01965249: Effect of Stitch Technique on the Occurrence of Incisional Hernia After Abdominal Wall Closure
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury of Abdominal Wall
Keywords: Laparotomy
short stitch
long stitch
MonoMax
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2013-10-18
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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®).


Eligibility criteria: 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

Primary outcomes:
measure: Incisional hernia rate
timeFrame: 1 year postoperatively
Secondary outcomes:
measure: Frequency of burst abdomen
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 days
measure: Reoperation due to burst abdomen
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 days
measure: Frequency of wound infections
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 days and 30 days postop
measure: Wound healing complications
timeFrame: until 30 days postoperatively
measure: Long Term Incisional hernia rate
timeFrame: 3 and 5 years postoperatively
measure: Long term Wound infections
timeFrame: 1 year postoperatively
measure: Long Term Wound healing complications
timeFrame: until 1 year postoperatively
measure: Costs
timeFrame: until 5 years postop
measure: Length of postoperative hospital stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 days
measure: Course of Health status with EQ-5D Score
timeFrame: preop, 30 days postop, 1 year, 3 years, 5 years postop
Other outcomes:
Locations:
city: Linz
country: Austria
facility: AKH Linz
city: Wien
country: Austria
facility: Wilhelminenspital Wien
city: Berlin
country: Germany
facility: Vivantes Klinikum Spandau
city: Braunschweig
country: Germany
facility: Städtisches Klinikum Braunschweig
city: Frankfurt
country: Germany
facility: Klinikum der Johann-Wolfgang-Goethe Universität
city: Göppingen
country: Germany
facility: Klinik am Eichert, Allgemeinchirurgische Klinik
city: München
country: Germany
facility: LMU Großhadern
city: Stuttgart
country: Germany
facility: Robert Bosch KH Stuttgart
city: Tuttlingen
country: Germany
facility: Klinikum Landkreis Tuttlingen, Klinik für Allgemein-, Viszeral, und Gefäßchirurgie
Study officials:
affiliation: Wilhelminenspital Wien
name: Rene Fortelny, Dr.
role: PRINCIPAL_INVESTIGATOR
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