Early Closure of Protective Ileostomy in Rectal Cancer Patients (ECPIS)

The Early Closure of the Protective Ileostomy After Low Anterior Resection Enables Correct Start of Chemotherapy

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.

Study Overview

• Status: Completed
• Conditions: Ileostomy - Stoma
• Intervention / Treatment: Procedure: Closure of the ileostomy

Detailed Description

The closure of the protective ileostomy created during the low anterior resection for rectal cancer to protect the colo-rectal anastomosis is inevitable to restore the continuity of the gastrointestinal tract. It usually takes place several months after the primary surgery, because the patients starts chemotherapy and cannot undergo the procedure during the therapy. It results in the relative low quality of life of the patient, as well as often leads to complications. Therefore, it seem reasonable to close the stoma as soon as possible to take the burden off patient.

It is well known that the healing process of the anastomosis runs in the three phases, but only two first are crucial for the clinical result. The second takes place between 5th and 14th postoperative day. Therefore it should be possible to perform successful restoration of the GI tract already after two weeks after operation, and not after many moths.

The aim of the study was to compare the restoration of the GI tract after 14 days and more than 3 months, so to compare the traditional and early strategy.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Skawina, Poland, 32-050
    • Stanley Dudrick's Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early closure; Closure of the ileostomy 14 days after the primary operation, in which it was created.	Procedure: Closure of the ileostomy; Surgical closure of the protective ileostomy (reconnection of intestinal loops)
Active Comparator: Late closure; Closure of the ileostomy more than 90 days after the primary operation, in which it was created.	Procedure: Closure of the ileostomy; Surgical closure of the protective ileostomy (reconnection of intestinal loops)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of postoperative fistulas	number of patients with the fistula of the anastomosis	3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timing of anticancer therapy	Time to the beginning of adiuvant chemotherapy	3 months after surgery

Collaborators and Investigators

• Sponsor: Stanley Dudrick's Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: December 5, 2016
• First Submitted That Met QC Criteria: December 19, 2016
• First Posted (Estimate): December 20, 2016

Study Record Updates

• Last Update Posted (Actual): April 3, 2018
• Last Update Submitted That Met QC Criteria: March 31, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Zespolenia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to make individual participant data (IPD) available to other researchers.