Gastrointestinal Anastomosis Using MonoPlus® Suture

Gastrointestinal Stromal Tumors Clinical Trial

— GASTROMO  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04811833
• Other study ID #: AAG-O-H-2005
• Status: Withdrawn
• Start date: July 2022
• Est. completion date: December 2023

Study information

• Verified date: April 2023
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Tumor
• Colonic Neoplasms
• Digestive System Neoplasm
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Gastrointestinal Stromal Tumors
• Intestinal Neoplasms
• Neoplasms
• Rectal Neoplasms
• Rectum Tumor
• Small Intestine Tumor
• Stomach Neoplasms
• Stomach Tumor

Locations

Country	Name	City	State
Spain	Servicio de Cirugía General y Digestiva, Sección cirugía	Madrid
Spain	Hospital Parc Taulí Sabadell	Sabadell	Cataluña

Sponsors (2)

Lead Sponsor	Collaborator
Aesculap AG	B.Braun Surgical SA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Length of the overall postoperative hospital stay	Number of days between date of surgery and date of discharge	until discharge (approximately 10 days postoperative)
Secondary	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)
Secondary	Duration to perform the anastomosis	Time in Minutes the surgeon needs to perform the anastomosis	intraoperatively
Secondary	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
Secondary	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
Secondary	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