NCT02997267

Brief Summary

The aim of the study was to compare the restoration of the GI tract by the closure of protective ileostomy after low anterior resection for rectal cancer after 14 days and more than 3 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 20, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

April 3, 2018

Status Verified

March 1, 2018

Enrollment Period

5 months

First QC Date

December 5, 2016

Last Update Submit

March 31, 2018

Conditions

Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

  • Number of postoperative fistulas

    number of patients with the fistula of the anastomosis

    3 months after surgery

Secondary Outcomes (1)

  • Timing of anticancer therapy

    3 months after surgery

Study Arms (2)

Early closure

EXPERIMENTAL

Closure of the ileostomy 14 days after the primary operation, in which it was created.

Procedure: Closure of the ileostomy

Late closure

ACTIVE COMPARATOR

Closure of the ileostomy more than 90 days after the primary operation, in which it was created.

Procedure: Closure of the ileostomy

Interventions

Closure of the ileostomyPROCEDURE

Surgical closure of the protective ileostomy (reconnection of intestinal loops)

Early closureLate closure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • more than 18 year old
  • the presence of the protective ileostomy created during the low anterior resection to protect the colo-rectal anastomosis

You may not qualify if:

  • the presence of the protective ileostomy created during any other procedure than the low anterior resection to protect the colo-rectal anastomosis
  • age \< 18 yo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanley Dudrick's Memorial Hospital

Skawina, 32-050, Poland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department

Study Record Dates

First Submitted

December 5, 2016

First Posted

December 20, 2016

Study Start

October 1, 2016

Primary Completion

March 1, 2017

Study Completion

December 31, 2017

Last Updated

April 3, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data (IPD) available to other researchers.

Locations

PL(1)