Pelvic Drain After Rectal Resection for Mid-low Rectal Ca... | NCT04573621

Studies
Pelvic Drain After Rectal Resection for Mid-low Rectal Cancer

NCT04573621

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Status

Unknown status

Last Update Posted

Oct 5, 2020Actual

Enrollment

518Estimated

Phase

Not Applicable

Conditions

Rectal Cancer

Interventions

Pelvic drain
No pelvic drain is placed

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2020Estimated

Primary Completion Date

Sep 2022Estimated

Completion Date

Sep 2022Estimated

First Submitted Date

Sep 24, 2020

First Submission Date that Met QC Criteria

Oct 1, 2020

First Posted Date

Oct 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2020

Last Update Posted Date

Oct 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

518Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pelvic drain	Active Comparator	Placement of a pelvic drain	Procedure: Pelvic drain
No pelvic drain	Experimental	No pelvic drain placed	Other: No pelvic drain is placed

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pelvic drain	Procedure	A pelvic drain is placed	Pelvic drain
No pelvic drain is placed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with pelvic sepsis	anastomotic leak or pelvic collections clinically or radiologically detected	0-30 days postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Management of pelvic sepsis	Type of management (medical, rediological, surgical)	0-30 days postoperatively
Postoperative complications	Overall postoperative complications

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eloy Espín-Basany	Contact	932746000	6587	eespin@vhebron.net

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital General Universitario Vall d´Hebron	Recruiting	Barcelona	Barcelona, Spain	08035	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided