Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Surgery; Ulcerative Colitis
• Intervention / Treatment: Diagnostic test: Indirect Calorimetry

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece, 10676
      • Evangelismos General Hospital of Athens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Ulcerative Colitis about to undergo proctocolectomy with ileoanal j-pouch anastomosis. As control group, it is planned to enroll patients about to undergo subtotal colectomy, matched with the patient group in terms of gender, age and body mass index.

Description

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.)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ulcerative Colitis patients undergoing proctocolectomy; Measurement of resting energy expenditure among patients with Ulcerative Colitis about to undergo proctocolectomy with ileoanal j-pouch anastomosis	Diagnostic test: Indirect Calorimetry; Resting energy expenditure measurement; Other Names: Resting energy expenditure measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of resting energy expenditure (kcal/day)	To evaluate total energy needs of patients who undergo proctocolectomy with ileoanal j-pouch	Before surgery, 1 week postoperatively, 3 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IBDQ	Inflammatory Bowel Disease Questionnaires (IBDQ), a widely used questionnaire for HRQoL assessment in patients with inflammatory bowel diseases (IBDs)	Before surgery and 1 week after Surgery
Resting energy expenditure change (kcal/day)	Changes in daily energy expenditure after surgery compared to pre surgery assesment.	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)	Longitudinal changes in Bristol stool form scale score before and after surgery.	Before surgery, 1 week postoperatively, 6 months after surgery
Post operative weight loss	Post operative weight loss will be assessed by measuring the post weight on the date of surgery and adjusting for the baseline weight in kg.	1 week postoperatively, 3 months postoperatively
Post operative Energy intake.	Total energy intake measured in calories after surgery.	1 week postoperatively, 3 months postoperatively

Collaborators and Investigators

• Sponsor: Evangelismos Hospital
• Investigators: Study Director: Dimitrios Karagiannis, Dr, Evangelismos General Hospital of Athens

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Estimated): October 25, 2024
• Study Completion (Estimated): December 25, 2025

Study Registration Dates

• First Submitted: January 2, 2024
• First Submitted That Met QC Criteria: January 15, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; energy requirements; ileoanal anastomosis; j-pouch
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: PouchEH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No