Pelvic Drain After Rectal Resection for Mid-low Rectal Cancer

NCT ID: NCT04573621

Last Updated: 2020-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

518 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-31

Study Completion Date

2022-09-30

Brief Summary

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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

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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.

Conditions

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Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
The assessor will not know whether the patient received a drain or not

Study Groups

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Pelvic drain

Placement of a pelvic drain

Group Type ACTIVE_COMPARATOR

Pelvic drain

Intervention Type PROCEDURE

A pelvic drain is placed

No pelvic drain

No pelvic drain placed

Group Type EXPERIMENTAL

No pelvic drain is placed

Intervention Type OTHER

A pelvic drain is not placed

Interventions

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Pelvic drain

A pelvic drain is placed

Intervention Type PROCEDURE

No pelvic drain is placed

A pelvic drain is not placed

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital General Universitario Vall d´Hebron

Barcelona, Barcelona, Spain, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Eloy Espín-Basany

Role: CONTACT

932746000 ext. 6587

Facility Contacts

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Eloy Espín Basany, MD PhD

Role: primary

934 893 000 ext. 6587

Other Identifiers

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GECO1

Identifier Type: -

Identifier Source: org_study_id

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