Injury of Abdominal Wall Clinical Trial
— ESTOIHOfficial 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
| Verified date | July 2023 |
| Source | Aesculap AG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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®).
| Status | Active, not recruiting |
| Enrollment | 425 |
| Est. completion date | December 2024 |
| Est. primary completion date | December 15, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | AKH Linz | Linz | |
| Austria | Wilhelminenspital Wien | Wien | |
| Germany | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Aesculap AG | B.Braun Surgical SA |
Austria, Germany,
Albertsmeier M, Hofmann A, Baumann P, Riedl S, Reisensohn C, Kewer JL, Hoelderle J, Shamiyeh A, Klugsberger B, Maier TD, Schumacher G, Kockerling F, Pession U, Weniger M, Fortelny RH. Effects of the short-stitch technique for midline abdominal closure: sh — View Citation
Albertsmeier M, Seiler CM, Fischer L, Baumann P, Husing J, Seidlmayer C, Franck A, Jauch KW, Knaebel HP, Buchler MW. Evaluation of the safety and efficacy of MonoMax(R) suture material for abdominal wall closure after primary midline laparotomy-a controlled prospective multicentre trial: ISSAAC [NCT005725079]. Langenbecks Arch Surg. 2012 Mar;397(3):363-71. doi: 10.1007/s00423-011-0884-6. Epub 2011 Dec 20. — View Citation
Diener MK, Voss S, Jensen K, Buchler MW, Seiler CM. Elective midline laparotomy closure: the INLINE systematic review and meta-analysis. Ann Surg. 2010 May;251(5):843-56. doi: 10.1097/SLA.0b013e3181d973e4. — View Citation
Fischer L, Baumann P, Husing J, Seidlmayer C, Albertsmeier M, Franck A, Luntz S, Seiler CM, Knaebel HP. A historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety and efficacy of MonoMax suture material for abdominal wall closure after primary midline laparotomy. ISSAAC-Trial [NCT005725079]. BMC Surg. 2008 Jul 21;8:12. doi: 10.1186/1471-2482-8-12. — View Citation
Fortelny RH, Andrade D, Schirren M, Baumann P, Riedl S, Reisensohn C, Kewer JL, Hoelderle J, Shamiyeh A, Klugsberger B, Maier TD, Schumacher G, Kockerling F, Pession U, Hofmann A, Albertsmeier M. Effects of the short stitch technique for midline abdominal — View Citation
Fortelny RH, Baumann P, Thasler WE, Albertsmeier M, Riedl S, Steurer W, Kewer JL, Shamiyeh A. Effect of suture technique on the occurrence of incisional hernia after elective midline abdominal wall closure: study protocol for a randomized controlled trial. Trials. 2015 Feb 15;16:52. doi: 10.1186/s13063-015-0572-x. — View Citation
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* Note: There are 17 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incisional hernia rate | Incisional hernia rate 1 year postoperatively (assessment by ultrasound). | 1 year postoperatively | |
| Secondary | Frequency of burst abdomen | Burst abdomen is defined as a clinically evident rupture of the laparotomy wound | participants will be followed for the duration of hospital stay, an expected average of 10 days | |
| Secondary | Reoperation due to burst abdomen | Burst abdomen is defined as a clinically evident rupture of the laparotomy wound | participants will be followed for the duration of hospital stay, an expected average of 10 days | |
| Secondary | Frequency of wound infections | Wound infections are classified according to the US centres for disease control and prevention (CDC) as either deep or superficial. | participants will be followed for the duration of hospital stay, an expected average of 10 days and 30 days postop | |
| Secondary | Wound healing complications | Wound healing complications: Seroma, hematoma, necrosis, fistula | until 30 days postoperatively | |
| Secondary | Long Term Incisional hernia rate | assessment by ultrasound | 3 and 5 years postoperatively | |
| Secondary | Long term Wound infections | Wound infections are classified according to the US centres for disease control and prevention (CDC) as either deep or superficial. | 1 year postoperatively | |
| Secondary | Long Term Wound healing complications | Wound healing complications: Seroma, hematoma, necrosis, fistula | until 1 year postoperatively | |
| Secondary | Costs | Costs including material cost, cost per operation minute, cost per hospital stay, cost saving per incisional hernia. | until 5 years postop | |
| Secondary | Length of postoperative hospital stay | Number of days the patient has to stay in hospital after the intervention | participants will be followed for the duration of hospital stay, an expected average of 10 days | |
| Secondary | 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. |
preop, 30 days postop, 1 year, 3 years, 5 years postop |