GASTROMO: Gastrointestinal Anastomosis Using MonoPlus® Suture

Sponsor

Aesculap AG (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04811833

Collaborator

B.Braun Surgical SA (Industry)

162

Enrollment

Locations

16.6

Anticipated Duration (Months)

Patients Per Site

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Stromal Tumors Gastrointestinal Neoplasms Digestive System Neoplasm Stomach Tumor Small Intestine Tumor Colon Tumor Rectum Tumor

Study Design

Study Type:

Observational

Anticipated Enrollment :

162 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 15, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Monoplus® Adult patients undergoing an elective, primary surgery within the gastrointestinal tract with the need for anastomosis.

Outcome Measures

Primary Outcome Measures

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

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 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 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 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 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 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 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 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
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
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
Length of the overall postoperative hospital stay [until discharge (approximately 10 days postoperative)]
Number of days between date of surgery and date of discharge
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"
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.
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria

Adult patients undergoing an elective open or laparoscopic primary tumor resection within GI tract (stomach, small intestine, large intestine , colon and rectum.
Age ≥ 18 years
ASA ≤ III
Written informed consent

Exclusion criteria

ASA ≥IV
Emergency operations
Peritonitis
Surgical interventions in the pancreas, oesophagus
Patients with traumatic perforations
Pregnant and/or breast-feeding women
Patients who had received chemotherapy within the last 4 weeks or radiotherapy on the treated region within the last 2 weeks
Patients who were receiving immunosuppressant therapy