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Pelvic Drain After Rectal Resection for Mid-low Rectal Cancer (GECO1)

Primary Purpose

Rectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pelvic drain
No pelvic drain is placed
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or Female, 18 year-of-age or above
  • Mid or low rectal cancer
  • Anastomosis below the peritoneal reflection
  • Total mesorectal excision (TME)
  • Capability to understand the study
  • Informed consent

Exclusion Criteria:

  • For women, pregnancy
  • Chronic kidney failure or hepatic failure, immunodepression, malnoutrition
  • Life expectancy < 6 months
  • Partial mesorectal excision
  • Abdominoperineal excision
  • Multivisceral resections
  • Emergency surgery

Sites / Locations

  • Hospital General Universitario Vall d´HebronRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Pelvic drain

No pelvic drain

Arm Description

Placement of a pelvic drain

No pelvic drain placed

Outcomes

Primary Outcome Measures

Number of participants with pelvic sepsis
anastomotic leak or pelvic collections clinically or radiologically detected

Secondary Outcome Measures

Management of pelvic sepsis
Type of management (medical, rediological, surgical)
Postoperative complications
Overall postoperative complications
CT scan or imaging needed
Necessity of performing unscheduled imaging tests
Number of participants with postoperative ileus
Postoperative ileus
Diagnostic delay for a leak
Days between surgery and leak detection
Length of postperative stay
Days of stay after surgery
Time to flatus and bowel movement
Days between surgery and flatus/faeces
Stoma presence at 1-year follow-up
Necessity of maintaining the diverting ileostomy at 1-year follow-up
Late pelvic collections
Presence of pelvic collections detected at longer follow-up intervals
Small bowel obstruction
Mechanical small bowel obstruction
Quality of life associated with a drain
Visual Analogue Scale 0-10 (higher score means better outcome) score of postoperative pain and wound complaints
Any complications associated with drain removal after surgery
Safety of drain removal after surgery

Full Information

First Posted
September 24, 2020
Last Updated
October 1, 2020
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04573621
Brief Title
Pelvic Drain After Rectal Resection for Mid-low Rectal Cancer
Acronym
GECO1
Official Title
Pelvic Drain After Rectal Resection for Mid-low Rectal Cancer: a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2020 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This RCT aims at assessing the effects of a pelvic drain after total mesorectal excision for mid-low rectal cancer on the rates of pelvic sepsis and anastomotic leaks.
Detailed Description
This is a 2-arm, non-inferiority RCT. Patients undergoing total mesorectal excision for mid-low rectal cancer will be randomly assigned into two groups: pelvic drain no pelvic drain. Patients will be followed-up to assess the rates of anastomotic leaks, pelvic sepsis and secondary outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The assessor will not know whether the patient received a drain or not
Allocation
Randomized
Enrollment
518 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pelvic drain
Arm Type
Active Comparator
Arm Description
Placement of a pelvic drain
Arm Title
No pelvic drain
Arm Type
Experimental
Arm Description
No pelvic drain placed
Intervention Type
Procedure
Intervention Name(s)
Pelvic drain
Intervention Description
A pelvic drain is placed
Intervention Type
Other
Intervention Name(s)
No pelvic drain is placed
Intervention Description
A pelvic drain is not placed
Primary Outcome Measure Information:
Title
Number of participants with pelvic sepsis
Description
anastomotic leak or pelvic collections clinically or radiologically detected
Time Frame
0-30 days postoperatively
Secondary Outcome Measure Information:
Title
Management of pelvic sepsis
Description
Type of management (medical, rediological, surgical)
Time Frame
0-30 days postoperatively
Title
Postoperative complications
Description
Overall postoperative complications
Time Frame
0-30 days postoperatively
Title
CT scan or imaging needed
Description
Necessity of performing unscheduled imaging tests
Time Frame
0-30 days postoperatively
Title
Number of participants with postoperative ileus
Description
Postoperative ileus
Time Frame
0-30 days postoperatively
Title
Diagnostic delay for a leak
Description
Days between surgery and leak detection
Time Frame
0-30 days postoperatively
Title
Length of postperative stay
Description
Days of stay after surgery
Time Frame
0-30 days postoperatively or until discharge
Title
Time to flatus and bowel movement
Description
Days between surgery and flatus/faeces
Time Frame
0-30 days postoperatively
Title
Stoma presence at 1-year follow-up
Description
Necessity of maintaining the diverting ileostomy at 1-year follow-up
Time Frame
12 months after surgery
Title
Late pelvic collections
Description
Presence of pelvic collections detected at longer follow-up intervals
Time Frame
up to 60 days after surgery
Title
Small bowel obstruction
Description
Mechanical small bowel obstruction
Time Frame
up to 60 days after surgery
Title
Quality of life associated with a drain
Description
Visual Analogue Scale 0-10 (higher score means better outcome) score of postoperative pain and wound complaints
Time Frame
30 days postoperatively
Title
Any complications associated with drain removal after surgery
Description
Safety of drain removal after surgery
Time Frame
up to 60 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or Female, 18 year-of-age or above Mid or low rectal cancer Anastomosis below the peritoneal reflection Total mesorectal excision (TME) Capability to understand the study Informed consent Exclusion Criteria: For women, pregnancy Chronic kidney failure or hepatic failure, immunodepression, malnoutrition Life expectancy < 6 months Partial mesorectal excision Abdominoperineal excision Multivisceral resections Emergency surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eloy Espín-Basany
Phone
932746000
Ext
6587
Email
eespin@vhebron.net
Facility Information:
Facility Name
Hospital General Universitario Vall d´Hebron
City
Barcelona
State/Province
Barcelona, Spain
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eloy Espín Basany, MD PhD
Phone
934 893 000
Ext
6587
Email
eespin@vhebron.net

12. IPD Sharing Statement

Plan to Share IPD
No

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Pelvic Drain After Rectal Resection for Mid-low Rectal Cancer

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