Gastrointestinal Anastomosis Using MonoPlus® Suture (GASTROMO)

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 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 Overview

• Status: Withdrawn
• Conditions: Gastrointestinal Neoplasms; Gastrointestinal Stromal Tumors; Digestive System Neoplasm; Rectum Tumor; Stomach Tumor; Colon Tumor; Small Intestine Tumor

• Study Type: Observational

Contacts and Locations

• Study Contact: Name: Irene Fita Esteban; Phone Number: +34 935 86 62 00; Email: irene.fita@bbraun.com

Study Locations

• Spain
  • Madrid, Spain, 28007
    • Servicio de Cirugía General y Digestiva, Sección cirugía
  • Cataluña
    • Sabadell, Cataluña, Spain, 08208
      • Hospital Parc Tauli Sabadell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Monoplus®; Adult patients undergoing an elective, primary surgery within the gastrointestinal tract with the need for anastomosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	until 6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	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	at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
Comparison of Abscess at different timepoints in postoperative course	Comparison of postoperative Abscess rate at different postoperative examinations	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	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	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	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	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	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	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	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	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	until discharge (approximately 10 days postoperative)
Duration to perform the anastomosis	Time in Minutes the surgeon needs to perform the anastomosis	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"	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.	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).	intraoperatively

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: B.Braun Surgical SA
• Investigators: Principal Investigator: Wenceslao Vasquez Jimenez, Dr., Hospital General Universitario Gregorio Maranon

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: colon tumor; stomach tumor; tumor disease; small intestine tumor; rectum tumor; need for anastomosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms by Site; Gastrointestinal Diseases; Stomach Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Colorectal Neoplasms; Neoplasms, Connective Tissue; Neoplasms; Stomach Neoplasms; Rectal Neoplasms; Gastrointestinal Stromal Tumors; Gastrointestinal Neoplasms; Digestive System Neoplasms; Colonic Neoplasms; Intestinal Neoplasms
• Other Study ID Numbers: AAG-O-H-2005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No