The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage Anastomotic Leakage
- Conditions
- Anastomotic LeakRectal CancerRectal Neoplasms
- Interventions
- Other: Tube drain insertion
- Registration Number
- NCT03325361
- Lead Sponsor
- University of Rome Tor Vergata
- Brief Summary
Anastomotic leakage (AL) is considered the commonest major complication after surgery for rectal cancer. Transanal tube drainage role in the prevention of AL is still debatable.
- Detailed Description
Patients who underwent low or ultralow anterior resection for rectal cancer were enrolled between 01/2015 and 06/2017. A de-Pezzer catheter was placed transanally after the creation of the anastomosis, secured to the buttocks, and connected to a urine bag to allow monitoring the amount and the color of the drainage. The catheter was removed on the 3rd day postoperative if the volume collected was insignificant.
Patients were followed-up on the ward and then in the outpatient's department at two weeks, and one month postoperative. Patients who were suspected to have AL underwent CT with rectal contrast to assess the integrity of the anastomosis. The primary outcome was the incidence of AL. We adopted the definition published by the International Study Group of Rectal Cancer.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Low or ultralow anterior resection with primary anastomosis for biopsy-proven primary rectal cancer
- No anastomosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TD Tube drain insertion -
- Primary Outcome Measures
Name Time Method Anastomotic leakage 30 days Prevention
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Policlinico Tor Vergata Hospital
🇮🇹Rome, RM, Italy