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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03325361
Enrollment
100
Registered
2017-10-30
Start date
2017-10-31
Completion date
2018-06-30
Last updated
2017-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic Leak, Rectal Cancer, Rectal Neoplasms

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.

Interventions

OTHERTube drain insertion

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.

Sponsors

University of Rome Tor Vergata
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* No anastomosis

Design outcomes

Primary

MeasureTime frameDescription
Anastomotic leakage30 daysPrevention

Countries

Italy

Contacts

Primary ContactPierpaolo Sileri, PhD
piersileri@yahoo.com3209353441
Backup ContactMostafa Shalaby, PhD
shalaby-mostafa@hotmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026