跳至主要内容
临床试验/NCT03893942
NCT03893942Unknown不适用

Psychological Predictors of Post-surgical Recovery in Inflammatory Bowel Disease: a Pilot Cohort Study

Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年4月16日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Correlation between psychological predictors questionnaires outcome and length of hospital stay

研究概览

简要总结

This is an observation pilot trial aimed to study to the association between mindfulness and other psychological factors, including both protective and risk factors, with recovery of functional ability following colorectal surgery for Inflammatory Bowel Diseases (IBD), including Crohn's disease and Ulcerative Colitis.

详细描述

The chronic nature of Inflammatory Bowel Disease (IBD) leads to a significant impact on patients' lives, beyond intestinal symptoms alone. The sequelae of this can be seen in the increased rates of depression and reduced quality of life (QoL). Surgery may provide a way to effectively induce long-term symptoms remission, although there is a short postoperative transitory period whereas quality of life might decrease. Over the last years, increasing interest has been gained by perioperative recovery protocols, aiming to accelerate functional recovery and to reduce complications. Some of these protocols include an in-depth discussion with both dedicated nurses and/or surgeons to decrease surgery-associated stress reaction. Nevertheless, no one of the proposed protocols has included a psychological assessment in order to correlate it with functional recovery. We suggest that studying the psychological characteristics of the patients (with a specific focus on mindfulness) could lead to open a new research front to optimize patients' outcomes.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients > 18 years old (both males and females).
  • Patients diagnosed with Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis).
  • Patients scheduled for elective open or laparoscopic surgery for curative intent.

排除标准

  • Patients unable to give the written informed consent.
  • Patients < 18 years old.
  • Patients undergoing surgery in emergency setting.
  • Patients with pre-operative evidence of colorectal cancer or High Grade/Low grade dysplasia.
  • Pregnant or breastfeeding patients.
  • Any condition that, in the opinion of the investigator, can interfere with the study protocol (e.g. neuropsychiatric disorders or dementia)

结局指标

主要结局

Correlation between psychological predictors questionnaires outcome and length of hospital stay

时间窗: Post-operative day 7

Length of stay calculated in days from the day of surgery until the day of discharge

Correlation between psychological predictors questionnaires outcome and quality of life

时间窗: Post-operative month 12

Quality of Life will be assessed by using the Short Inflammatory Bowel Disease Quality of Life Questionnaire (S_IBDQOL)

次要结局

未报告次要终点

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验