Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-02-22 @ 6:45 PM
Study NCT ID:
NCT03926858
Status:
COMPLETED
Last Update Posted:
2024-06-05
First Post:
2019-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient-reported Outcomes of Postsurgical Pain and Health Related Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-04', 'studyFirstSubmitDate': '2019-04-17', 'studyFirstSubmitQcDate': '2019-04-23', 'lastUpdatePostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health related quality of life(HRQoL)', 'timeFrame': 'up to 6 months after surgery', 'description': 'HRQoL is measured with EuroQol five-dimensional questionnaire(EQ-5D).'}, {'measure': 'Pain after surgery', 'timeFrame': 'up to 6 months after surgery', 'description': 'Postsurgical pain is measured with the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) .'}], 'secondaryOutcomes': [{'measure': 'ambulation time', 'timeFrame': 'up to 30 days after surgery', 'description': 'the first time when patients can get off of bed and walk after surgery'}, {'measure': 'oral feeding time', 'timeFrame': 'up to 30 days after surgery', 'description': 'the first time when patients begin oral feeding after surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['post-surgical pain', 'health-related quality of life'], 'conditions': ['Post Surgical Pain']}, 'referencesModule': {'references': [{'pmid': '24237004', 'type': 'BACKGROUND', 'citation': 'Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014 Jan;30(1):149-60. doi: 10.1185/03007995.2013.860019. Epub 2013 Nov 15.'}, {'pmid': '23279591', 'type': 'BACKGROUND', 'citation': 'Taylor RS, Ullrich K, Regan S, Broussard C, Schwenkglenks M, Taylor RJ, Gordon DB, Zaslansky R, Meissner W, Rothaug J, Langford R; PAIN-OUT investigators. The impact of early postoperative pain on health-related quality of life. Pain Pract. 2013 Sep;13(7):515-23. doi: 10.1111/papr.12026. Epub 2012 Dec 23.'}, {'pmid': '36894887', 'type': 'DERIVED', 'citation': 'Zhang Q, Wu Y, Hong S, Feng Y. Trajectory of worst pain within the first two weeks following pelvic and sacral tumor surgery and long-term outcome: a pilot observational prospective cohort study. BMC Anesthesiol. 2023 Mar 9;23(1):73. doi: 10.1186/s12871-023-02033-z.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nTo 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. Patients' medical charts will be reviewed by investigators to record sociodemographic and clinical data."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing the following procedures: breast surgery, thoracic surgery, abdominal surgery, orthopedic surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Undergoing general or regional anesthesia\n* Hospitalized for at least 24 hours after surgery\n\nExclusion Criteria:\n\n* Existing diagnoses of psychiatric pathology\n* Surgery cancellation\n* Unable to give informed consent\n* Unable to read and write'}, 'identificationModule': {'nctId': 'NCT03926858', 'acronym': 'HRQoL', 'briefTitle': 'Patient-reported Outcomes of Postsurgical Pain and Health Related Quality of Life', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Patient-reported Outcomes of Postsurgical Pain and Health Related Quality of Life, a Multi-centered, Prospective, Observational, Cohort Study', 'orgStudyIdInfo': {'id': '2018PHB229-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': 'The First Affiliated Hospital of Guangxi Medical University', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'city': 'Xingtai', 'state': 'Hebei', 'country': 'China', 'facility': "Xingtai People's Hospital", 'geoPoint': {'lat': 37.06217, 'lon': 114.49272}}, {'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': "The Third People's Hospital of Hubei Province", 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'The First Hospital of Changsha', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'The Third Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Baotou', 'state': 'Inner Mongolia', 'country': 'China', 'facility': 'The Affiliated Hospital of Inner Mongolia Medical University', 'geoPoint': {'lat': 40.6516, 'lon': 109.84389}}, {'city': 'Hohhot', 'state': 'Inner Mongolia', 'country': 'China', 'facility': 'Huhhot First Hospital', 'geoPoint': {'lat': 40.81056, 'lon': 111.65222}}, {'city': 'Nanyang', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 31.87389, 'lon': 121.70889}}, {'city': 'Songyuan', 'state': 'Jilin', 'country': 'China', 'facility': 'Songyuan Central Hospital', 'geoPoint': {'lat': 45.12902, 'lon': 124.82769}}, {'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': "Shanxi Provincial People's Hospital", 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': 'First Affiliated Hospital of Xinjiang Medical University', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'city': 'Liangshan', 'state': 'Yunan', 'country': 'China', 'facility': "The First People's Hospital of Liangshan Yi Autonomous Prefecture", 'geoPoint': {'lat': 35.07319, 'lon': 105.974}}, {'city': 'Yuxi', 'state': 'Yunnan', 'country': 'China', 'facility': "People's Hospital of Yuxi", 'geoPoint': {'lat': 24.355, 'lon': 102.54222}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Hangzhou Red Cross Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Tongde Hospital of Zhejiang Province', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Xiyuan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chongqing', 'country': 'China', 'facility': "The Ninth People's Hospital of Chongqing", 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Huadong Hospital Affiliated to Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Tianjin', 'country': 'China', 'facility': 'The Second Hospital of Tianjin Medical University', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Yi Feng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}, {'name': 'Xiumei Gao, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Xiyuan Hospital'}, {'name': 'Jingzhi Liu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tianjin Medical University Second Hospital'}, {'name': 'Guanghe Si, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Songyuan Central Hospital'}, {'name': 'Yaying Xie', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Affiliated Hospital of Inner Mongolia Medical University'}, {'name': 'Jun Yan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Huhhot First Hospital'}, {'name': 'Aizhi Li', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Yantai Yuhuangding Hospital'}, {'name': 'Weiwei Zhang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Shanxi Provincial People's Hospital"}, {'name': 'Zhenhua Qu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Xingtai People's Hospital"}, {'name': 'Ying Wang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Affiliated Hospital of Zhengzhou University'}, {'name': 'Hongguang Bao', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}, {'name': 'Weidong Gu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Huadong Hospital'}, {'name': 'Fan Tao', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Red Cross Hospital, Hangzhou, China'}, {'name': 'Hongwei Wang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zhejiang Provincial Tongde Hospital'}, {'name': 'Xianwei Zhang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tongji Hospital'}, {'name': 'Qingpeng Dong', 'role': 'STUDY_DIRECTOR', 'affiliation': "The Third People's Hospital of Hubei Province"}, {'name': 'Qin Liao', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Third Xiangya Hospital of Central South University'}, {'name': 'Caiping Liao', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine'}, {'name': 'Haihua Shu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Guangdong Second Provincial Central Hospital'}, {'name': 'Zhijun Chen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Guilin Medical University, China'}, {'name': 'Yubo Xie', 'role': 'STUDY_DIRECTOR', 'affiliation': 'First Affiliated Hospital of Guangxi Medical University'}, {'name': 'Bangxiang Yang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'West China Hospital'}, {'name': 'Hui Huang', 'role': 'STUDY_DIRECTOR', 'affiliation': "The Ninth People's Hospital of Chongqing"}, {'name': 'Xiang Shen', 'role': 'STUDY_DIRECTOR', 'affiliation': "The First People's Hospital of Liangshan Yi Autonomous Prefecture"}, {'name': 'Shaoxing Dong', 'role': 'STUDY_DIRECTOR', 'affiliation': "People's Hospital of Yuxi"}, {'name': 'Yimei Li', 'role': 'STUDY_DIRECTOR', 'affiliation': 'First Affiliated Hospital of Xinjiang Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of department of anesthesiology and pain management', 'investigatorFullName': 'Yi Feng, MD', 'investigatorAffiliation': "Peking University People's Hospital"}}}}