Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery

NCT06221995 | Active Not Recruiting

• 1 other identifier: PouchEH
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ulcerative Colitis; Surgery

Keywords

Ulcerative Colitis; energy requirements; ileoanal anastomosis; j-pouch

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 Arms (1)

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

Interventions

Indirect Calorimetry DIAGNOSTIC_TEST

Resting energy expenditure measurement

Also known as: Resting energy expenditure measurement

Ulcerative Colitis patients undergoing proctocolectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Evangelismos Hospital: lead

Study Sites (1)

Evangelismos General Hospital of Athens

Athens, Attica, 10676, Greece

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Dimitrios Karagiannis, Dr

  Evangelismos General Hospital of Athens

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Clinical Nutrition, Evaggelismos General Hospital, Athens

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 24, 2024
• Study Start: September 25, 2023
• Primary Completion: October 25, 2024
• Study Completion: December 25, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

GR (1)