Ulcerative ColitisNCT06221995
Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery
An observational study of Ulcerative Colitis and Surgery, run by Evangelismos Hospital at 1 site in Greece.
Trial summary
A prospective observational study to assess the energy needs of Ulcerative Colitis patients undergoing total proctocolectomy with ileoanal j-pouch anastomosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis, Surgery
- What is being tested?
- Indirect Calorimetry
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- 25 Sep 2023to 25 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ulcerative Colitis, Surgery
- Being tested
- Indirect Calorimetry
- Keywords
- Ulcerative Colitis, energy requirements, ileoanal anastomosis, j-pouch
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect CalorimetryDiagnostic test
Also called Resting energy expenditure measurement
Resting energy expenditure measurement
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative Colitis patients undergoing proctocolectomy | Measurement of resting energy expenditure among patients with Ulcerative Colitis about to undergo proctocolectomy with ileoanal j-pouch anastomosis Receives: Diagnostic Test: Indirect Calorimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of resting energy expenditure (kcal/day)
To evaluate total energy needs of patients who undergo proctocolectomy with ileoanal j-pouch
Measured: Before surgery, 1 week postoperatively, 3 months postoperatively
Secondary outcomes (5)
IBDQ
Inflammatory Bowel Disease Questionnaires (IBDQ), a widely used questionnaire for HRQoL assessment in patients with inflammatory bowel diseases (IBDs)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 week postoperatively, 3 months postoperatively
Post operative Energy intake.
Total energy intake measured in calories after surgery.
Measured: 1 week postoperatively, 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start25 Sep 2023
- Primary completion25 Oct 2024 (estimated)
- Study completion25 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evangelismos Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Karayiannis, Evangelismos Hospital
- Investigators
- Dimitrios Karagiannis, Dr, Study director, Evangelismos General Hospital of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221995
- Sponsor's protocol ID
- PouchEH
- Status last verified
- Sep 2024
- First submitted
- 2 Jan 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Requirements in Patients With Ulcerative Colitis Undergoing Total Rectocolectomy and Ileoanal Anastomosis J-pouch
- ClinicalTrials.gov ID
- NCT06221995
- Acronym / sponsor ID
- PouchEH
- Conditions
- Ulcerative Colitis, Surgery
- Keywords
- Ulcerative Colitis, energy requirements, ileoanal anastomosis, j-pouch
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Evangelismos HospitalUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 25 Oct 2024 (estimated)
- Study completion
- 25 Dec 2025 (estimated)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ulcerative Colitis patients undergoing proctocolectomy | – | Diagnostic Test: Indirect CalorimetryMeasurement of resting energy expenditure among patients with Ulcerative Colitis about to undergo proctocolectomy with ileoanal j-pouch anastomosis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indirect CalorimetryAlso: Resting energy expenditure measurementResting energy expenditure measurement | Diagnostic test | Ulcerative Colitis patients undergoing proctocolectomy |
Primary outcome
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
5 secondary outcomes
IBDQ
Time frame: Before surgery and 1 week after Surgery
Resting energy expenditure change (kcal/day)
Time frame: 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)
Time frame: Before surgery, 1 week postoperatively, 6 months after surgery
Post operative weight loss
Time frame: 1 week postoperatively, 3 months postoperatively
Post operative Energy intake.
Time frame: 1 week postoperatively, 3 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitrios Karagiannis, Dr study director
Evangelismos General Hospital of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis and Surgery, run by Evangelismos Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of resting energy expenditure (kcal/day) (time frame: Before surgery, 1 week postoperatively, 3 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.