Clinical trial · Observational
Gastrointestinal Anastomosis Using MonoPlus® Suture
Assessment of MonoPlus® Suture Material for Anastomosis in the Gastrointestinal Tract. A Prospective, Multi-centric, International, Single-arm, Observational Study in Daily Practice
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Tumor | Colon Neoplasm | ALIAS | 0.90 |
| Digestive System Neoplasm | Digestive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
| Gastrointestinal Stromal Tumors | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
| Rectum Tumor | Rectal Neoplasm | PROBABILISTIC | 0.70 |
| Small Intestine Tumor | Small Intestinal Neoplasm | ALIAS | 0.90 |
| Stomach Tumor | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Monoplus®
- description
- Adult patients undergoing an elective, primary surgery within the gastrointestinal tract with the need for anastomosis.
Primary outcomes (1)
- measure
- Comparison of anastomosis leakage rate at different timepoints in postoperative course
- timeFrame
- until 6 months after surgery
- description
- The primary endpoint of this study is the anastomosis leakage rate until 6 months after surgery
Secondary outcomes (18)
- 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.
- description
- Comparison of the dehiscence rate of the suture line at different postoperative examinations
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available