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Cola

Adult patients undergoing an elective, primary surgery within the gastrointestinal tract with the need for anastomosis.

Wenceslao Vasquez Jimenez, Dr.

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.

Gastrointestinal Anastomosis Using MonoPlus® Suture

Assessment of MonoPlus® Suture Material for Anastomosis in the Gastrointestinal Tract. A Prospective, Multi-centric, International, Single-arm, Observational Study in Daily Practice

The primary endpoint of this study is the anastomosis leakage rate until 6 months after surgery

Comparison of the dehiscence rate of the suture line at different postoperative examinations

Comparison of the Peritonitis rate of the suture line at different postoperative examinations

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 postoperative Bleeding rate at different postoperative examinations

Comparison of postoperative Abscess rate at different postoperative examinations

Comparison of postoperative Fistula rate at different postoperative examinations

Comparison of postoperative Perforation rate at different postoperative examinations

Comparison of postoperative Obstipation rate at different postoperative examinations

Comparison of postoperative Stenosis rate at different postoperative examinations

Comparison of Reoperation rate due to an anastomosis leakage at different postoperative examinations

Comparison of postoperative Mortality rate at different postoperative examinations

Comparison of postoperative Stoma rate at different postoperative examinations

Number of days between date of surgery and date of discharge

Number of days the patient has to stay in the intensive care unit after the intervention

Time in Minutes the surgeon needs to perform the anastomosis

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"

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.

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).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Gastrointestinal Anastomosis Using MonoPlus® Suture	NCT04811833	Gastrointestina... Gastrointestina... Digestive Syste... Stomach Tumor Small Intestine... Colon Tumor Rectum Tumor		18 Years -	Aesculap AG
Gastrointestinal Anastomosis Using MonoPlus® Suture	NCT04811833	Gastrointestina... Gastrointestina... Digestive Syste... Stomach Tumor Small Intestine... Colon Tumor Rectum Tumor		18 Years -	Aesculap AG

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