Patient-reported Outcomes of Postsurgical Pain and Health Related Quality of Life (HRQoL)
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|ClinicalTrials.gov Identifier: NCT03926858|
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : May 19, 2020
|Condition or disease|
|Post Surgical Pain|
Pain and recovery after surgery are extremely concerned by patients undergoing surgery. Though it is important to understand the recovery course of postsurgical pain and recovery, most previous studies just focused on one specific time point, and the results were inconsistent.
To investigate the impact of PSP on HRQoL within the first six months following surgery using PRO measures, patients undergoing several specific surgeries will be interviewed. The investigator will approach to the screened patients one day before surgery (Day-1), using a letter of invitation to explain the survey, and obtain an informed consent. Questionnaires for pre-surgical assessment will be administrated by a face-to-face interview. Follow-ups will be performed at several time-points within six month after surgery to evaluate pain and recovery by face-to-face interview or by telephone interview if the patient is discharged. Patients' medical charts will be reviewed by investigators to record sociodemographic and clinical data.
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||Patient-reported Outcomes of Postsurgical Pain and Health Related Quality of Life, a Multi-centered, Prospective, Observational, Cohort Study|
|Actual Study Start Date :||June 12, 2019|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||December 2021|
- The trajectories of health related quality of life(HRQoL) [ Time Frame: up to 6 months after surgery ]The trajectory of HRQoL is the vector of Utility values measured with EuroQol five-dimensional questionnaire(EQ-5D)taken over 6 months(days 1, 3, 7,14, 21, 30, 60, 90, 120, 150,180; Day 0 is the day of surgery). The EQ-5D measures health on five domains (mobility, self-care, usual activities, pain discomfort, and anxiety-depression), and the scores will be combined using Chinese general population weights to generate a single utility or index score. Utility values for the EQ-5D range from 1.00 to -0.391, where a score of 0 and 1 are regarded as equivalent to death and 'perfect health', respectively, and a score < 0 is considered as health state that is 'worse than death'.
- pain trajectories after surgery [ Time Frame: up to 6 months after surgery ]The pain trajectory is the vector of mean pain severity domain scores (from 0 to 10)measured with pain severity domain of the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) and Brief Pain Inventory -Short Form (BPI-SF) within 6 months after surgery(days 1, 3, 7,14, 21, 30, 60, 90, 120, 150,180; Day 0 is the day of surgery).
- ambulation time [ Time Frame: up to 30 days after surgery ]the first time when patients can get off of bed and walk after surgery
- oral feeding time [ Time Frame: up to 30 days after surgery ]the first time when patients begin oral feeding after surgery
- Complications within 30 days after surgery [ Time Frame: up to 30 days after surgery ]Complications within 30 days after surgery will be classified using Clavien-Dindo Classification of Surgical Complications, ranging from Grade I(Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions) to Grade V(death of a patient).
- Number of readmission within 30 days after surgery [ Time Frame: up to 30 days after surgery ]Readmission indicates unplanned readmission after hospital discharge.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926858
|Contact: Yi Feng, MD, PhDemail@example.com|
|Principal Investigator:||Yi Feng, PhD||Peking University People's Hospital|
|Study Director:||Xiumei Gao, MD||Xiyuan Hospital|
|Study Director:||Jingzhi Liu||Tianjin Medical University Second Hospital|
|Study Director:||Guanghe Si, MD||Songyuan Central Hospital|
|Study Director:||Yaying Xie||The Affiliated Hospital of Inner Mongolia Medical University|
|Study Director:||Jun Yan||Huhhot First Hospital|
|Study Director:||Aizhi Li||Yantai Yuhuangding Hospital|
|Study Director:||Weiwei Zhang, MD||Shaanxi Provincial People's Hospital|
|Study Director:||Zhenhua Qu, MD||Xingtai People's Hospital|
|Study Director:||Ying Wang, MD||The First Affiliated Hospital of Zhengzhou University|
|Study Director:||Hongguang Bao||The First Affiliated Hospital with Nanjing Medical University|
|Study Director:||Weidong Gu||Huadong Hospital|
|Study Director:||Fan Tao||Hangzhou Red Cross Hospital|
|Study Director:||Hongwei Wang||Zhejiang Provincial Tongde Hospital|
|Study Director:||Xianwei Zhang||Tongji Hospital|
|Study Director:||Qingpeng Dong||The third people's Hospital of Hubei Province|
|Study Director:||Qin Liao||The Third Xiangya Hospital of Central South University|
|Study Director:||Caiping Liao||The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine|
|Study Director:||Haihua Shu||Guangdong Second Provincial Central Hospital|
|Study Director:||Zhijun Chen||Guilin Medical University, China|
|Study Director:||Yubo Xie||First Affiliated Hospital of Guangxi Medical University|
|Study Director:||Bangxiang Yang||West China Hospital|
|Study Director:||Hui Huang||The Ninth People's Hospital of Chongqing|
|Study Director:||Xiang Shen||The First People's Hospital of Liangshan Yi Autonomous Prefecture|
|Study Director:||Shaoxing Dong||People's Hospital of Yuxi|
|Study Director:||Yimei Li||First Affiliated Hospital of Xinjiang Medical University|