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Active, Not Recruiting

NCT Number: NCT06221995

Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Evangelismos General Hospital of Athens

Athens, Attica, 10676, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

indirect calorimetry

Diagnostic Test

Resting energy expenditure measurement

Other names: Resting energy expenditure measurement

Primary outcomes

  1. 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

  1. IBDQ

    Time frame: Before surgery and 1 week after Surgery

    Inflammatory Bowel Disease Questionnaires (IBDQ), a widely used questionnaire for HRQoL assessment in patients with inflammatory bowel diseases (IBDs)

  2. Resting energy expenditure change (kcal/day)

    Time frame: 1 week postoperatively and 3 months postoperatively

    Changes in daily energy expenditure after surgery compared to pre surgery assesment.

  3. Bristol stool form scale, min: type 1 (hard solid stools, better outcome) - max: type 7 (liquid stools, worst outcome)

    Time frame: Before surgery, 1 week postoperatively, 6 months after surgery

    Longitudinal changes in Bristol stool form scale score before and after surgery.

  4. Post operative weight loss

    Time frame: 1 week postoperatively, 3 months postoperatively

    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.

  5. Post operative Energy intake.

    Time frame: 1 week postoperatively, 3 months postoperatively

    Total energy intake measured in calories after surgery.

Sponsors and collaborators

Lead sponsor

Evangelismos Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 24, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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