WithdrawnNot Applicable

Gastrointestinal Anastomosis Using MonoPlus® Suture

Stopped: The GASTROMO study has been stopped early before enrolling its first patient because the results of our primary endpoint would have been inconsistent. The variability of the leakage rate between all anastomosis included in the study was overly high.

Spain0Started 2022-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Comparison of anastomosis leakage rate at different timepoints in postoperative course

Timeframe: until 6 months after surgery

Trial details

NCT IDNCT04811833

SponsorAesculap AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-12

View on ClinicalTrials.gov More Gastrointestinal Stromal Tumors trials