Status:
WITHDRAWN
Gastrointestinal Anastomosis Using MonoPlus® Suture
Lead Sponsor:
Aesculap AG
Collaborating Sponsors:
B.Braun Surgical SA
Conditions:
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Eligibility:
All Genders
18+ years
Brief 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 effica...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04811833
Start Date
July 1 2022
End Date
December 1 2023
Last Update
April 5 2023
Active Locations (2)
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1
Hospital Parc Taulí Sabadell
Sabadell, Catalonia, Spain, 08208
2
Servicio de Cirugía General y Digestiva, Sección cirugía
Madrid, Spain, 28007