Clinical trial · Observational
An International, Multicentric, Prospective, Observational Study to Evaluate Monosyn® Suture Material for Anastomoses in the Gastrointestinal Tract
An International, Multicentric, Prospective, Observational Study to Evaluate Monosyn® Suture Material for Anastomoses in the Gastrointestinal Tract.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Planned recruitment of 630 patients was not possible to achieve within the given time frame
Summary
Brief summary (as posted)
The aim of this non-interventional study is to evaluate the efficacy of a monofilament, mid-term absorbable suture material (Monosyn®) for anastomosis performed in the gastrointestinal tract using the frequency of anastomosis leakage as a primary parameter. Postoperative complication rate, length of hospital stay, costs, time to perform the anastomosis and handling will serve as secondary endpoints. The question is addressed, whether a monofilament suture material is as effective as a braided suture material for anastomosis construction within the gastrointestinal tract.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| C.Surgical Procedure; Digestive System | — | UNRESOLVED | — |
| Gastric Anastomosis (Site) | — | UNRESOLVED | — |
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
| Symptomatic Disorders of the Gastrointestinal Tract | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Monosyn | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Monosyn
- description
- Construction of a gastrointestinal anastomoses
- interventionNames
- Device: Monosyn
Primary outcomes (1)
- measure
- Frequency of anastomosis leakage rate
- timeFrame
- participants will be followed for the duration of hospital stay, an expected average of 7 days
- description
- Anastomotic leak is defined as radiographic demonstration of a fistula or non-absorbable material drainage from a wound after oral administration, or visible disruption of the suture line during re-exploration.
Secondary outcomes (7)
- measure
- Postoperative complication rate
- timeFrame
- participants will be followed for the duration of hospital stay, an expected average of 7 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years and older * ASA I-III * Indication for an elective tumor surgery within the GI tract (stomach, small intestine, large intestine) * Written informed consent Exclusion Criteria: * Emergency surgery * Peritonitis * Patients undergoing an operation due to a tumour within the pancreas, rectum, esophagus * Pregnant women and breast-feeding women * Chemotherapy * Current immunosuppressive therapy * Radiotherapy on the treated region within the last 2 months
References
Publications (1)
- RESULTBaumann P, Kim J, Ahn SH, Kim HH, Chong HY, Wente MN. Mid-term absorbable monofilament is safe and effective for gastrointestinal anastomosis - PROMEGAT - A single-arm prospective observational study. Ann Med Surg (Lond). 2018 Apr 6;30:1-6. doi: 10.1016/j.amsu.2018.04.003. eCollection 2018 Jun. PMID 29946452