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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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