WithdrawnNo phase
Gastrointestinal Anastomosis Using MonoPlus® Suture
Key facts
- Who runs it
- Aesculap AG
- Where
- Spain2 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Started
- Jul 2022
- Ended
- Dec 2023
- Type of study
- Observational
- Record updated
- 5 April 2023
- Why it 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.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- Surgical interventions in the pancreas, oesophagus
- 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
- ASA ≥IV
- Emergency operations
- Peritonitis
- Patients with traumatic perforations
- Pregnant and/or breast-feeding women
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
This study has been designed to implement an action within the framework of a proactive Post Market Clinical Follow up (PMCF) activity.
The group in the trial
- Monoplus®
Adult patients undergoing an elective, primary surgery within the gastrointestinal tract with the need for anastomosis.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 5 April 2023