Clinical trial NCT04811833: Gastrointestinal Anastomosis Using MonoPlus® Suture
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasm
Stomach Tumor
Small Intestine Tumor
Colon Tumor
Rectum Tumor
Keywords: tumor disease
stomach tumor
small intestine tumor
colon tumor
rectum tumor
need for anastomosis
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2021-03-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing an elective, primary surgery within the gastrointestinal tract with the need for ananastomosis.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of anastomosis leakage rate at different timepoints in postoperative course
timeFrame: until 6 months after surgery
Secondary outcomes:
measure: Comparison of dehiscence rate of the suture line at different timepoints in postoperative course
timeFrame: at discharge (approximately 10 days after surgery), 1 month and 6 months after surgery.
measure: Comparison of the Peritonitis rate at different timepoints in postoperative course
timeFrame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
measure: Comparison of the Surgical Site infection rate at different timepoints in postoperative course
timeFrame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
measure: Comparison of bleeding at different timepoints in postoperative course
timeFrame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
measure: Comparison of Abscess at different timepoints in postoperative course
timeFrame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
measure: Comparison of Postoperative Fistula at different timepoints in postoperative course
timeFrame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
measure: Comparison of Postoperative Perforation at different timepoints in postoperative course
timeFrame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
measure: Comparison of Postoperative Obstipation at different timepoints in postoperative course
timeFrame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
measure: Comparison of Postoperative Stenosis at different timepoints in postoperative course
timeFrame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
measure: Comparison of Reoperation rate due to an anastomosis leakage at different timepoints in postoperative course
timeFrame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
measure: Comparison of Mortality rate at different timepoints in postoperative course
timeFrame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
measure: Comparison of Stoma rate at different timepoints in postoperative course
timeFrame: at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery
measure: Length of the overall postoperative hospital stay
timeFrame: until discharge (approximately 10 days postoperative)
measure: Length of the postoperative stay in intensive care unit
timeFrame: until discharge (approximately 10 days postoperative)
measure: Duration to perform the anastomosis
timeFrame: intraoperatively
measure: Course of Health Status
timeFrame: until 6 months postoperative
measure: Satisfaction of the patient with the surgery
timeFrame: at discharge (approximately 10 days postoperative), 1 month, and 6 months after surgery
measure: Assessment of suture material handling parameters
timeFrame: intraoperatively
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital Parc Taulí Sabadell
state: Cataluña
city: Madrid
country: Spain
facility: Servicio de Cirugía General y Digestiva, Sección cirugía
Study officials:
affiliation: Hospital General Universitario Gregorio Marañon
name: Wenceslao Vasquez Jimenez, Dr.
role: PRINCIPAL_INVESTIGATOR
References: