Gastrointestinal Anastomosis Using MonoPlus® Suture (GASTROMO)

Aesculap

Status: Withdrawn

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

Study type: Observational

Funder types: Industry

Identifiers

NCT04811833

AAG-O-H-2005

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

0 participants in 1 patient group

Monoplus®

Description:

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