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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
Sponsor:
Information provided by (Responsible Party):
Yi Feng, MD, Peking University People's Hospital

Tracking Information
First Submitted Date April 17, 2019
First Posted Date April 25, 2019
Last Update Posted Date May 19, 2020
Actual Study Start Date June 12, 2019
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2019)
  • 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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 23, 2019)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Patient-reported Outcomes of Postsurgical Pain and Health Related Quality of Life
Official Title Patient-reported Outcomes of Postsurgical Pain and Health Related Quality of Life, a Multi-centered, Prospective, Observational, Cohort Study
Brief Summary This study will investigate the impact of post-surgical pain (PSP) on health related quality of life (HRQoL) within the first six months following surgery using patient-reported outcome (PRO) measures, and to investigate medical recovery measures such as ambulation and oral feeding time as secondary outcomes.
Detailed Description

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patients undergoing the following procedures: breast surgery, thoracic surgery, abdominal surgery, total knee or hip replacement surgery and spine surgery.
Condition Post Surgical Pain
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 23, 2019)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 18 years or older
  • Undergoing general or regional anesthesia
  • Hospitalized for at least 24 hours after surgery
  • Able to give informed consent
  • Able to read and write

Exclusion Criteria:

  • Existing diagnoses of psychiatric or neurologic pathology
  • A history of substance abuse
  • Admitted to ICU after surgery
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Yi Feng, MD, PhD 86-010-88325581 littlevon@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03926858
Other Study ID Numbers 2018PHB229-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Yi Feng, MD, Peking University People's Hospital
Study Sponsor Peking University People's Hospital
Collaborators Not Provided
Investigators
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
PRS Account Peking University People's Hospital
Verification Date May 2020