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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03325361
• Other study ID #: Transanal Tube Drainage
• Status: Recruiting
• Phase: N/A
• First received: October 24, 2017
• Last updated: October 24, 2017
• Start date: October 2017
• Est. completion date: June 2018

Study information

• Verified date: October 2017
• Source: University of Rome Tor Vergata
• Contact: Pierpaolo Sileri, PhD
• Phone: 3209353441
• Email: piersileri[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No anastomosis

Related Conditions & MeSH terms

• Anastomotic Leak
• Rectal Cancer
• Rectal Neoplasms

Intervention

Other:
• Tube 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.

Locations

Country	Name	City	State
Italy	Policlinico Tor Vergata Hospital	Rome	RM

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anastomotic leakage	Prevention	30 days