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NCT Number: NCT01287637

Early Closure of Temporary Ileostomy

The study is being conducted as a prospective randomized controlled multicenter study of patients with a temporary ileostomy due to rectal cancer. The study will be conducted in hospitals in Denmark and Sweden under the framework of the Scandinavian Surgical Outcomes Group (www.ssorg.net).

The study investigates the effect of reversing a temporary ileostomy after 8-13 days instead of later reversal more than 12 weeks after surgery.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herlev Hospital, University of Copenhagen

Herlev, 2730, Denmark

About this study

After creation of the temporary ileostomy patients are included and are randomized to two groups. Patients in the intervention group will have the stoma closed 8-13 days after stoma creation and will be compared to patients in the control group where the stoma is closed after a minimum of 12 weeks (standard treatment in Denmark and Sweden).

Before randomization the eligible patients undergo a CT of the rectum to visualise the anastomosis and possible leakage. Furthermore, the local investigators may choose to supplement the CT with a rectoscopy.

The research group includes 89 patients over an expected period of 4 years. Both groups are examined for postoperative complications as well as stoma-related complications at discharge and 3, 6 and 12 months after stoma creation.

The research group also examines the impact on patients´ health-related quality of life at 3, 6 and 12 months after stoma creation.

Finally the socio-economic effect in both groups will be analyzed and compared 6 and 12 months after stoma creation.

An interim analysis is planned for safety as well as recalculation of statistical power.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with a temporary ileostomy after low anterior resection because of rectal cancer
  • Patients, who are physically and mentally fit to undergo surgery within 8-13 days

Exclusion criteria

  • Patients whose stoma is not reversible
  • Patients with diabetes
  • Patients being treated with Steroids
  • Patients with communicative problems
  • Patients with expected compliance issues

Treatment and study plan

Early reversal of temporary ileostomy

Procedure

Temporary ileostomy is reversed 8-13 days after the primary surgery

Other names: stoma reversal 8-13 days post surgery

Standard reversal of temporary ileostomy

Procedure

Patients in the control group will have the ileostomy reversed according to standard treatment, which is 12-26 weeks after primary operation

Other names: stoma reversal 12-26 weeks after stoma creation

Primary outcomes

  1. Postsurgical morbidity

    Time frame: 3 months after inclusion

    Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.

  2. Postsurgical morbidity

    Time frame: 6 months after inclusion

    Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.

  3. Postsurgical morbidity.

    Time frame: 12 months after inclusion-

    Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.

Secondary outcomes

  1. Quality of life

    Time frame: Quality of life is assessed at 3 months after inclusion

    Patients quality of life is assessed with three questionnaires that supplement each other: Short Form 36 (SF-36), Ostomy Adjustment Scale (OAS) and European Organization for the Treatment of Cancer CR30+CR29 (EORTC QLQ-CR30+CR29)

  2. Quality of life

    Time frame: Quality of life is assessed at 6 months after inclusion

    Patients quality of life is assessed with three questionnaires that supplement each other: Short Form 36 (SF-36), Ostomy Adjustment Scale (OAS) and European Organization for the Treatment of Cancer CR30+CR29 (EORTC QLQ-CR30+CR29)

  3. Quality of life

    Time frame: Quality of life is assessed at 12 months after inclusion

    Patients quality of life is assessed with three questionnaires that supplement each other: Short Form 36 (SF-36), Ostomy Adjustment Scale (OAS) and European Organization for the Treatment of Cancer CR30+CR29 (EORTC QLQ-CR30+CR29)

  4. Socio-economic effect of early reversal of temporary ileostomy

    Time frame: The investigators assess and analyze the economic effect 6 months after inclusion

    The investigators register all admissions to hospital and out-patient clinics up to 12 months after the operation. Furthermore, the investigators apply patients´self-reported data on visits to general practitioner, primary care nurses and other health care workers in primary care.

  5. Socio-economic effect of early reversal of temporary ileostomy

    Time frame: The investigators assess and analyze the economic effect 12 months after inclusion

    The investigators register all admissions to hospital and out-patient clinics up to 12 months after the operation. Furthermore, the investigators apply patients´self-reported data on visits to general practitioner, primary care nurses and other health care workers in primary care.

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Official study title

Early Closure of Temporary Ileostomy- a Randomized Clinical Trial

Acronym: EASY

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Feb 1, 2011
Registry last updated
Jan 20, 2016

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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