跳至主要内容
临床试验/NCT06221995
NCT06221995进行中(未招募)不适用

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

Evangelismos Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年9月25日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
30
试验地点
1
主要终点
Amount of resting energy expenditure (kcal/day)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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;

排除标准

  • 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.)

结局指标

主要结局

Amount of resting energy expenditure (kcal/day)

时间窗: Before surgery, 1 week postoperatively, 3 months postoperatively

To evaluate total energy needs of patients who undergo proctocolectomy with ileoanal j-pouch

次要结局

  • 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)

研究者

发起方
Evangelismos Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dimitrios Karayiannis

Director, Department of Clinical Nutrition, Evaggelismos General Hospital, Athens

Evangelismos Hospital

研究点 (1)

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