Early Surgery Versus Conservative Treatment in Patients With Ileocaecal Crohn's Disease (ESPRIT)

April 26, 2016 updated by: Ondrej Ryska

Early Surgery Versus Conservative Treatment in Patients With Ileocaecal Crohn's Disease - Prospective Randomized Study

This study compares the efficacy of early surgical with medical treatment in patients with ileocaecal uncomplicated Crohn's disease. The patients with affected short part of terminal ileum will be randomized either for laparoscopic ileocaecal resection or standard step-up pharmacological therapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Surgical therapy is currently indicated for Crohn's disease (CD) patients after conservative treatment becomes ineffective. The principles of so-called step-up therapy (STUP) where surgery represents the last therapeutical option are still followed.

Early surgical intervention (Early Surgery - ES) can be an alternative even in patients with uncomplicated type of CD before all medical therapy is used (Top-down approach). Limited resection under these conditions will lead to immediate remission. Moreover, laparoscopic ileocaecal resection is safe with low morbidity and regarding potential complications of step-up treatment might be beneficial for the patient.

Before wide introduction of ES approach into clinical practice, it is necessary to perform a randomized trial comparing early resection with the standard step-up medical therapy.

The potential effect of early, intensive therapy (ileocaecal resection) on biological behavior of the disease has not been studied that is why patients with uncomplicated ileocaecal form are the most suitable for such a trial. Significant number of these patients will indeed progress into more unfavorable course of the disease (relapse, complicated form, early recurrence).

Other potential benefit of early resection is the extended period without necessary medication. Even pharmacological recurrence prevention is not needed after surgery in uncomplicated CD patient if other risk factors are excluded. Rapid remission induced by surgery can lead to faster improvement of quality of life than long-term medication.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic, 625 00
        • The University Hospital Brno
      • Ceske Budejovice, Czech Republic, 370 01
        • Hospital České Budějovice
      • Horovice, Czech Republic, 26831
        • Horovice Hospital
      • Hradec Kralove, Czech Republic, 50005
        • Universitiy Hospital Hradec Kralove
      • Jihlava, Czech Republic, 586 33
        • Hospital Jihlava
      • Liberec, Czech Republic, 460 63
        • Hospital Liberec
      • Ostrava - Vitkovice, Czech Republic, 703 84
        • Vitkovice Hospital
      • Pilsen, Czech Republic, 323 18
        • University Hospital in Pilsen
      • Prague, Czech Republic, 140 21
        • Institute for Clinical and Experimental Medicine
      • Prague, Czech Republic, 100 34
        • Royal Vinohrady University Hospital
      • Prague, Czech Republic, 150 00
        • Na Homolce Hospital
      • Prague, Czech Republic, 170 00
        • Iscare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  • All patients aged 18-65 years with a uncomplicated ileocaecal form of Crohn's disease (affected < 20 cm of terminal ileum) (type: L1B1) diagnosed within last 12 months
  • Diagnose confirmed by endoscopy including appropriate extent of disease and presence of ulcers in terminal ileum
  • Patient is able to understand the study and sign an informed consent

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Previous bowel resection or other extensive abdominal surgery, which primarily excludes laparoscopic approach
  • Affected other parts of the digestive tract or symptomatic stenosis or stenosis impassable for the endoscope or presence of prestenotic dilatation in terminal ileum confirmed by enterography
  • Any extraluminal complications of Crohn's disease (fistula, abscess)
  • Affected part of terminal ileum longer than 20 cm
  • Severe comorbidities (heart failure, renal failure, liver failure, severe disorders of the central and peripheral nervous system, serious infectious disease) or patient with ASA (American Society of Anesthesiologists) III and more
  • Malnutrition or presence of another serious risk factor, which contradicts construction of primary anastomosis
  • Current use of immunosuppressive or biologic therapy

Other exclusion criteria:

  • Different intraoperative finding
  • Protocol violation
  • Subject refuses further participation in the study
  • Termination of the trial by responsible authority

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early Surgery - ES
Early laparoscopic ileocaecal resection
Procedure: Ileocaecal resection
laparoscopic ileocaecal resection with primary anastomosis
No Intervention: Step-up therapy - STUP
Treatment with step-up conservative approach according to good clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopic remission
Time Frame: 24 months
The rate of endoscopic remission defined as Rutgeerts score ≤ 1 and SES-CD = 0 in early surgery and standard step-up therapy group respectively
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QoL
Time Frame: 24 months
Quality of life measured by IBDQ, IBD Disability index
24 months
Clinical remission
Time Frame: 24 months
Clinical remission defined by Crohn's disease activity index < 150
24 months
Drug consumption
Time Frame: 24 months
Overall drug consumption (corticosteroids, antibiotics, immunomodulators, biologic therapy)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ondrej Ryska

Investigators

  • Principal Investigator: Ondrej Ryska, Dr, PhD, Section of IBD surgery - Czech Surgical Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

March 17, 2016

First Submitted That Met QC Criteria

March 17, 2016

First Posted (Estimate)

March 23, 2016

Study Record Updates

Last Update Posted (Estimate)

April 28, 2016

Last Update Submitted That Met QC Criteria

April 26, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBDchirCZ-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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