Clinical trial NCT06221995: Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery
Official title: Energy Requirements in Patients With Ulcerative Colitis Undergoing Total Rectocolectomy and Ileoanal Anastomosis J-pouch
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ulcerative Colitis
Surgery
Keywords: Ulcerative Colitis
energy requirements
ileoanal anastomosis
j-pouch
Lead sponsor: Evangelismos Hospital
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.)

Primary outcomes:
measure: Amount of resting energy expenditure (kcal/day)
timeFrame: Before surgery, 1 week postoperatively, 3 months postoperatively
Secondary outcomes:
measure: IBDQ
timeFrame: Before surgery and 1 week after Surgery
measure: Resting energy expenditure change (kcal/day)
timeFrame: 1 week postoperatively and 3 months postoperatively
measure: Bristol stool form scale, min: type 1 (hard solid stools, better outcome) - max: type 7 (liquid stools, worst outcome)
timeFrame: Before surgery, 1 week postoperatively, 6 months after surgery
measure: Post operative weight loss
timeFrame: 1 week postoperatively, 3 months postoperatively
measure: Post operative Energy intake.
timeFrame: 1 week postoperatively, 3 months postoperatively
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Evangelismos General Hospital of Athens
state: Attica
Study officials:
affiliation: Evangelismos General Hospital of Athens
name: Dimitrios Karagiannis, Dr
role: STUDY_DIRECTOR
References: