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.
Study Type
OBSERVATIONAL
Hospital Parc Taulí Sabadell
Sabadell, Catalonia, Spain
Servicio de Cirugía General y Digestiva, Sección cirugía
Madrid, Spain
Comparison of anastomosis leakage rate at different timepoints in postoperative course
The primary endpoint of this study is the anastomosis leakage rate until 6 months after surgery
Time frame: until 6 months after surgery
Comparison of dehiscence rate of the suture line at different timepoints in postoperative course
Comparison of the dehiscence rate of the suture line at different postoperative examinations
Time frame: at discharge (approximately 10 days after surgery), 1 month and 6 months after surgery.
Comparison of the Peritonitis rate at different timepoints in postoperative course
Comparison of the Peritonitis rate of the suture line at different postoperative examinations
Time frame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of the Surgical Site infection rate at different timepoints in postoperative course
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.
Time frame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of bleeding at different timepoints in postoperative course
Comparison of postoperative Bleeding rate at different postoperative examinations
Time frame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of Abscess at different timepoints in postoperative course
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Comparison of postoperative Abscess rate at different postoperative examinations
Time frame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of Postoperative Fistula at different timepoints in postoperative course
Comparison of postoperative Fistula rate at different postoperative examinations
Time frame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of Postoperative Perforation at different timepoints in postoperative course
Comparison of postoperative Perforation rate at different postoperative examinations
Time frame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of Postoperative Obstipation at different timepoints in postoperative course
Comparison of postoperative Obstipation rate at different postoperative examinations
Time frame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of Postoperative Stenosis at different timepoints in postoperative course
Comparison of postoperative Stenosis rate at different postoperative examinations
Time frame: 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 timepoints in postoperative course
Comparison of Reoperation rate due to an anastomosis leakage at different postoperative examinations
Time frame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of Mortality rate at different timepoints in postoperative course
Comparison of postoperative Mortality rate at different postoperative examinations
Time frame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of Stoma rate at different timepoints in postoperative course
Comparison of postoperative Stoma rate at different postoperative examinations
Time frame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Length of the overall postoperative hospital stay
Number of days between date of surgery and date of discharge
Time frame: until discharge (approximately 10 days postoperative)
Length of the postoperative stay in intensive care unit
Number of days the patient has to stay in the intensive care unit after the intervention
Time frame: until discharge (approximately 10 days postoperative)
Duration to perform the anastomosis
Time in Minutes the surgeon needs to perform the anastomosis
Time frame: intraoperatively
Course of Health Status
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"
Time frame: until 6 months postoperative
Satisfaction of the patient with the 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.
Time frame: at discharge (approximately 10 days postoperative), 1 month, and 6 months after surgery
Assessment of suture material handling parameters
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).
Time frame: intraoperatively