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

University of Rome Tor Vergata

Status: Unknown

Conditions: Rectal Neoplasms; Anastomotic Leak; Rectal Cancer

Treatments: Other: Tube drain insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT03325361

Transanal Tube Drainage

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Low or ultralow anterior resection with primary anastomosis for biopsy-proven primary rectal cancer

Exclusion criteria

• No anastomosis

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

TD

Experimental group

Treatment:

Other: Tube drain insertion

NTD

No Intervention group