Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06221995
• Other study ID #: PouchEH
• Status: Active, not recruiting
• Start date: September 25, 2023
• Est. completion date: December 25, 2025

Study information

• Verified date: January 2024
• Source: Evangelismos Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 25, 2025
• Est. primary completion date: September 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Surgery
• Ulcer
• Ulcerative Colitis

Intervention

Device:
• Indirect Calorimetry
Resting energy expenditure measurement

Locations

Country	Name	City	State
Greece	Evangelismos General Hospital of Athens	Athens	Attica

Sponsors (1)

Lead Sponsor	Collaborator
Evangelismos Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting energy expenditure measured in kcal/day using indirect calorimetry	Assessment of the energy needs of patients who undergo proctocolectomy with ileoanal j-pouch	Before surgery, 1 week postoperatively, 3 months postoperatively
Secondary	Assess calories, carbohydrate, fat and micronutrient intake	Assessment of patients' energy , carbohydrate, fat and micronutrient intake via Intake 24h recall.	Before surgery, 1 week postoperatively, 3 months postoperatively
Secondary	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
Secondary	Resting energy expenditure change (kcal/day)	Changes in energy expenditure after surgery measured by indirect calorimetry	1 week postoperatively and 3 months postoperatively
Secondary	Bristol stool form scale	Bristol stool form scale of before and after surgery	Before surgery, 1 week postoperatively, 6 months after surgery