Gastrointestinal Anastomosis Using MonoPlus® Suture
- Conditions
- Gastrointestinal NeoplasmsStomach TumorSmall Intestine TumorRectum TumorGastrointestinal Stromal TumorsColon TumorDigestive System Neoplasm
- Registration Number
- NCT04811833
- Lead Sponsor
- Aesculap AG
- Brief Summary
The primary aim of this study is to collect clinical data on the performance of MonoPlus® suture applied in routine clinical practice. Diverse parameters are to be used to assess the safety and efficacy of MonoPlus® suture for gastrointestinal anastomosis construction.
This study has been designed to implement an action within the framework of a proactive Post Market Clinical Follow up (PMCF) activity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of anastomosis leakage rate at different timepoints in postoperative course until 6 months after surgery The primary endpoint of this study is the anastomosis leakage rate until 6 months after surgery
- Secondary Outcome Measures
Name Time Method Comparison of Postoperative Obstipation at different timepoints in postoperative course at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery Comparison of postoperative Obstipation rate at different postoperative examinations
Assessment of suture material handling parameters intraoperatively Assessment of the handling of the suture material intra-operatively using a questionnaire including different dimensions (knot security, tensile strength, knot run down, stiffness) with 5 evaluation levels (excellent, very good, good, satisfied, poor).
Comparison of dehiscence rate of the suture line at different timepoints in postoperative course at discharge (approximately 10 days after surgery), 1 month and 6 months after surgery. Comparison of the dehiscence rate of the suture line at different postoperative examinations
Comparison of bleeding at different timepoints in postoperative course at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery Comparison of postoperative Bleeding rate at different postoperative examinations
Comparison of Postoperative Fistula at different timepoints in postoperative course at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery Comparison of postoperative Fistula rate at different postoperative examinations
Comparison of the Peritonitis rate at different timepoints in postoperative course at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery Comparison of the Peritonitis rate of the suture line at different postoperative examinations
Comparison of Abscess at different timepoints in postoperative course at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery Comparison of postoperative Abscess rate at different postoperative examinations
Comparison of Postoperative Perforation at different timepoints in postoperative course at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery Comparison of postoperative Perforation rate at different postoperative examinations
Comparison of Postoperative Stenosis at different timepoints in postoperative course at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery Comparison of postoperative Stenosis rate at different postoperative examinations
Length of the overall postoperative hospital stay until discharge (approximately 10 days postoperative) Number of days between date of surgery and date of discharge
Comparison of the Surgical Site infection rate at different timepoints in postoperative course at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery Incidence of postoperative surgical site infections, SSI (A1: Superficial incisional site infections and A2: Deep incisional surgical site infections) (efficacy parameter) Surgical Site Infection (SSI) is defined according to the definition of the US Centres for Disease Control and Prevention (CDC) at different postoperative examinations.
Comparison of Reoperation rate due to an anastomosis leakage at different timepoints in postoperative course at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery Comparison of Reoperation rate due to an anastomosis leakage at different postoperative examinations
Comparison of Mortality rate at different timepoints in postoperative course at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery Comparison of postoperative Mortality rate at different postoperative examinations
Comparison of Stoma rate at different timepoints in postoperative course at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery Comparison of postoperative Stoma rate at different postoperative examinations
Satisfaction of the patient with the surgery at discharge (approximately 10 days postoperative), 1 month, and 6 months after surgery This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "maximal pain". The values are compared over postoperative period.
Length of the postoperative stay in intensive care unit until discharge (approximately 10 days postoperative) Number of days the patient has to stay in the intensive care unit after the intervention
Duration to perform the anastomosis intraoperatively Time in Minutes the surgeon needs to perform the anastomosis
Course of Health Status until 6 months postoperative EQ-5D-5L is a standardized measure of health status developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L is designed for self-completion by respondents and it takes only a few minutes to complete. Instructions to respondents are included in the questionnaire. EQ-5D-5L consists of 2 pages - descriptive system and the EQ visual Analogue scale (EQ-VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the respondents self rated health on a 20 cm vertical , visual analogue scale with endpoints labelled "the best health you can imagine" and " the worst health you can imagine"
Trial Locations
- Locations (2)
Hospital Parc Taulí Sabadell
🇪🇸Sabadell, Cataluña, Spain
Servicio de Cirugía General y Digestiva, Sección cirugía
🇪🇸Madrid, Spain