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Completed

NCT Number: NCT02997267

Early Closure of Protective Ileostomy in Rectal Cancer Patients

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanley Dudrick's Memorial Hospital

Skawina, 32-050, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Closure of the ileostomy

Procedure

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

Primary outcomes

  1. Number of postoperative fistulas

    Time frame: 3 months after surgery

    number of patients with the fistula of the anastomosis

Secondary outcomes

  1. Timing of anticancer therapy

    Time frame: 3 months after surgery

    Time to the beginning of adiuvant chemotherapy

Sponsors and collaborators

Lead sponsor

Stanley Dudrick's Memorial Hospital

Other

Registry information

Official study title

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

Acronym: ECPIS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 20, 2016
Registry last updated
Apr 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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