Clinical Trials Directory

Trials / Unknown

UnknownNCT03325361

The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage Anastomotic Leakage

The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
University of Rome Tor Vergata · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERTube drain insertionA 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.

Timeline

Start date
2017-10-01
Primary completion
2017-12-01
Completion
2018-06-01
First posted
2017-10-30
Last updated
2017-10-30

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT03325361. Inclusion in this directory is not an endorsement.