Long stitch
DeviceAWC with the long stitch technique using MonoMax USP 1, 150 cm loop, HR48 mm
Completed
NCT Number: NCT01965249
Effect of Stitch Technique on the Occurrence of Incisional Hernia After Abdominal Wall Closure
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®).
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
AKH Linz, Linz, Austria
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Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Short Stitch
DeviceShort stitch suture technique using MonoMax USP 2/0, 150 cm, HR26 mm
Primary outcomes
-
Incisional hernia rate
Time frame: 1 year postoperatively
Incisional hernia rate 1 year postoperatively (assessment by ultrasound).
Secondary outcomes
-
Frequency of burst abdomen
Time frame: 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
-
Reoperation due to burst abdomen
Time frame: 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
-
Frequency of wound infections
Time frame: 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.
-
Wound healing complications
Time frame: until 30 days postoperatively
Wound healing complications: Seroma, hematoma, necrosis, fistula
-
Long Term Incisional hernia rate
Time frame: 3 and 5 years postoperatively
assessment by ultrasound
-
Long term Wound infections
Time frame: 1 year postoperatively
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
Time frame: until 1 year postoperatively
Wound healing complications: Seroma, hematoma, necrosis, fistula
-
Costs
Time frame: until 5 years postop
Costs including material cost, cost per operation minute, cost per hospital stay, cost saving per incisional hernia.
-
Length of postoperative hospital stay
Time frame: 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
-
Course of Health status with EQ-5D Score
Time frame: 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.
Sponsors and collaborators
Lead sponsor
Aesculap AG
Industry
Collaborators
- B.Braun Surgical SA
Registry information
Official study 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
Acronym: ESTOIH
Important dates
- Study start
- 2014
- Primary completion
- 2019
- Study completion
- 2024
- First posted
- Oct 18, 2013
- Registry last updated
- Sep 8, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.