Back to resultsThe Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage Anastomotic Leakage
Primary Purpose
Rectal Cancer, Rectal Neoplasms, Anastomotic Leak
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Tube drain insertion
Sponsored by
About this trial
This is an interventional prevention trial for Rectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Low or ultralow anterior resection with primary anastomosis for biopsy-proven primary rectal cancer
Exclusion Criteria:
- No anastomosis
Sites / Locations
- Policlinico Tor Vergata HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
TD
NTD
Arm Description
Outcomes
Primary Outcome Measures
Anastomotic leakage
Prevention
Secondary Outcome Measures
Full Information
NCT ID
NCT03325361
First Posted
October 24, 2017
Last Updated
October 24, 2017
Sponsor
University of Rome Tor Vergata
1. Study Identification
Unique Protocol Identification Number
NCT03325361
Brief Title
The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage Anastomotic Leakage
Official Title
The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2017 (Anticipated)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rome Tor Vergata
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Rectal Neoplasms, Anastomotic Leak
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TD
Arm Type
Experimental
Arm Title
NTD
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Tube drain insertion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anastomotic leakage
Description
Prevention
Time Frame
30 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Low or ultralow anterior resection with primary anastomosis for biopsy-proven primary rectal cancer
Exclusion Criteria:
No anastomosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierpaolo Sileri, PhD
Phone
3209353441
Email
piersileri@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa Shalaby, PhD
Email
shalaby-mostafa@hotmail.com
Facility Information:
Facility Name
Policlinico Tor Vergata Hospital
City
Rome
State/Province
RM
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierpaolo Sileri
Phone
3209353441
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage Anastomotic Leakage
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