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Clinical Trials/NCT06221995
NCT06221995
Active, not recruiting
Not Applicable

Energy Requirements in Patients With Ulcerative Colitis Undergoing Total Rectocolectomy and Ileoanal Anastomosis J-pouch

Evangelismos Hospital1 site in 1 country30 target enrollmentSeptember 25, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ulcerative Colitis
Sponsor
Evangelismos Hospital
Enrollment
30
Locations
1
Primary Endpoint
Amount of resting energy expenditure (kcal/day)
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 25, 2023
End Date
December 25, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Evangelismos Hospital
Responsible Party
Principal Investigator
Principal Investigator

Dimitrios Karayiannis

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

Evangelismos Hospital

Eligibility Criteria

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.)

Outcomes

Primary Outcomes

Amount of resting energy expenditure (kcal/day)

Time Frame: Before surgery, 1 week postoperatively, 3 months postoperatively

To evaluate total energy needs of patients who undergo proctocolectomy with ileoanal j-pouch

Secondary Outcomes

  • IBDQ(Before surgery and 1 week after Surgery)
  • Resting energy expenditure change (kcal/day)(1 week postoperatively and 3 months postoperatively)
  • Bristol stool form scale, min: type 1 (hard solid stools, better outcome) - max: type 7 (liquid stools, worst outcome)(Before surgery, 1 week postoperatively, 6 months after surgery)
  • Post operative weight loss(1 week postoperatively, 3 months postoperatively)
  • Post operative Energy intake.(1 week postoperatively, 3 months postoperatively)

Study Sites (1)

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