Status:
UNKNOWN
The Impact of Transanal Decompression Tube Placement After Colorectal Anastomosis: A Randomized Trial
Lead Sponsor:
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Conditions:
Colorectal Cancer
Postoperative Complications
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
There is currently no standardization in the use of the transanal decompressive tube during the postoperative after a colorectal surgery. The available evidence is based on studies with methodological...
Detailed Description
One of the complications of performing the colorectal anastomosis is the anastomotic leak, which sometimes entails the need for reinterventions and stoma formation (provisional or definitive). In rece...
Eligibility Criteria
Inclusion
- Patients undergoing scheduled laparoscopic, robotic or laparotomic colorectal cancer surgery who undergo colorectal anastomosis.
- Both mechanical and manual colorectal anastomosis with or without diverting ileostomy.
- Negative intraoperative air-leak test.
- Height of the anastomosis: promontory or distal to it.
- Age≥18 years.
- Histology of Adenocarcinoma with or without prior neoadjuvant treatment.
- Any T, any N, any M.
- Informed consent signed by the patient and by the researcher.
Exclusion
- No performance of colorectal anastomosis.
- Colorectal tumor with histology other than adenocarcinoma or adenoma.
- Patients with psychiatric illnesses, addictions or any disorder that prevents understanding of surgery.
- Inability to read or understand any of the informed consent languages (Catalan, Spanish).
- Emergency surgery.
- Any patient who, due to his medical characteristics, presents a high individual risk when being included and completing the study.
Key Trial Info
Start Date :
July 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 10 2023
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT04890015
Start Date
July 10 2017
End Date
July 10 2023
Last Update
September 2 2021
Active Locations (1)
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1
Hospital Universitari Dr. Josep Trueta de Girona
Girona, Spain, 17007