Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery

NCT ID: NCT06221995

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-25

Study Completion Date

2025-12-25

Brief Summary

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A prospective observational study to assess the energy needs of Ulcerative Colitis patients undergoing total proctocolectomy with ileoanal j-pouch anastomosis.

Detailed Description

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Total proctocolectomy with creation of ileoanal j-pouch anastomosis is the gold-standard surgical procedure for familial polyposis, for ulcerative colitis unresponsive to medication and for colitis associated with dysplasia requiring total colectomy.

Patients postoperatively face difficulties in maintaining their physical condition and quality of life due to potential complications such as surgical, mechanical, inflammatory and functional disorders increasing the rates of malnutrition. Postoperative changes as regards anthropometric characteristics and nutritional status have not been fully elucidated.

Therefore, the need arises to calculate the energy needs of patients with ileoanal j-pouch anastomosis, given the lack of corresponding data and the possible differentiation of energy needs from a similar group of patients undergoing colorectal surgery.

Of particular interest is the body composition of ileoanal anastomosis patients, which has been studied very little ), and the extent to which their energy needs are met, given dietary restrictions both preoperatively and postoperatively.

It is therefore necessary to determine the energy needs, as well as the degree of their coverage by the diet, of UC patients undergoing proctocolectomy with creation of ileoanal j-pouch anastomosis.

Conditions

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Ulcerative Colitis Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ulcerative Colitis patients undergoing proctocolectomy

Measurement of resting energy expenditure among patients with Ulcerative Colitis about to undergo proctocolectomy with ileoanal j-pouch anastomosis

Indirect Calorimetry

Intervention Type DIAGNOSTIC_TEST

Resting energy expenditure measurement

Interventions

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Indirect Calorimetry

Resting energy expenditure measurement

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Resting energy expenditure measurement

Eligibility Criteria

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Inclusion Criteria

* Patients with ulcerative colitis and planned proctocolectomy with ileoanal j-pouch anastomosis surgery or patients who are to undergo subtotal colectomy.
* Age over 18 years.
* Written informed consent to take part in the study.
* Speaking ability in Greek or English.
* Able to get tested fasted;

Exclusion Criteria

* Age under 18 years.
* Existence of pregnancy.
* Inability to breathe inside the indirect calorimetry mask for the time required for the measurement.
* Use of medications that may affect body metabolism will be evaluated individually (e.g. cortico-steroids etc.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Evangelismos Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dimitrios Karayiannis

Director, Department of Clinical Nutrition, Evaggelismos General Hospital, Athens

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dimitrios Karagiannis, Dr

Role: STUDY_DIRECTOR

Evangelismos General Hospital of Athens

Locations

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Evangelismos General Hospital of Athens

Athens, Attica, Greece

Site Status

Countries

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Greece

Other Identifiers

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PouchEH

Identifier Type: -

Identifier Source: org_study_id

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