Early Closure of Protective Ileostomy in Rectal Cancer Patients

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02997267

Acronym

ECPIS

Enrollment

Registered

2016-12-20

Start date

2016-10-31

Completion date

2017-12-31

Last updated

2018-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ileostomy - Stoma

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.

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.

Interventions

PROCEDUREClosure of the ileostomy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026