Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2025-12-31 @ 8:00 PM
Study NCT ID:
NCT05782205
Status:
UNKNOWN
Last Update Posted:
2023-11-22
First Post:
2023-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgeons' Mental Distress and Risks After Severe Complications Following Radical Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2023-03-09', 'studyFirstSubmitQcDate': '2023-03-21', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Surgeons' mental health", 'timeFrame': 'June 01, 2023 to August 31, 2024.', 'description': "The clinical features collected in the questionnaire relating to the surgeons' mental distress included: i) feeling burnout, anxiety, or depression; ii) avoiding radical gastrectomy or feeling stress, slowing down the process during radical gastrectomy operations; iii) having physical reactions, including heart pounding, trouble breathing, or sweating while recalling; iv) having urges to quit being a surgeon; v) taking psychiatric medications; and vi) seeking psychological counseling. Meeting any one of the above six clinical features was regarded as having mental distress; Meeting ore or two was defined as mild mental distress, and meeting three or more was defined as severe mental distress."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mental Health']}, 'referencesModule': {'references': [{'pmid': '37158145', 'type': 'DERIVED', 'citation': "He H, Lin C, Li R, Zang L, Huang X, Liu F. Surgeons' mental distress and risks after severe complications following radical gastrectomy in China: a nationwide cross-sectional questionnaire. Int J Surg. 2023 Aug 1;109(8):2179-2184. doi: 10.1097/JS9.0000000000000463."}]}, 'descriptionModule': {'briefSummary': "Surgeons experience higher levels of work stress, even under normal circumstances. Many can suffer from substantial levels of mental health issues, especially when faced with severe complications. However, due to a variety of reasons, many surgeons are reluctant to disclose mental health issues or seek psychological help.\n\nGastric cancer is the fifth most common malignancy globally and accounts for the fourth leading cause of death from cancer. In China specifically, gastric cancer is a major public health issue, with some 400,000 new cases diagnosed every year. Of those cases, more than 80% patients are at advanced stages when diagnosed. At present, radical gastrectomy is considered the standard approach for patients with resectable advanced gastric cancer. Severe complications following radical gastrectomy ranged from 2.7% to 9.4% worldwide. In addition to delaying patients' recovery courses, severe complications also place enormous pressure on chief surgeons who performed the operations. Such pressures may bring great risks of psychological distress.\n\nSurgeons are also the victims when they encounter severe complications following radical gastrectomy. Their mental distress should not be minimized. Until now, little has been known about the effects of surgical complications on surgeons. In the current study, based on a large-scale questionnaire survey in China, the investigators aimed to investigate incidences of surgeons' mental distress following severe complications after radical gastrectomy. The investigators also aimed to identify independent risk factors which could help develop strategies to improve the mental well-being of these surgeons after such incidences."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Enrolled as many surgeons as possible within the research time', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* General and/or gastrointestinal surgeons who experienced severe complications after radical gastrectomy.\n\nExclusion Criteria:\n\n* Other conditions that do not meet the inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT05782205', 'briefTitle': "Surgeons' Mental Distress and Risks After Severe Complications Following Radical Gastrectomy", 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': "Surgeons' Mental Distress and Risks After Severe Complications Following Radical Gastrectomy in China: a Nationwide Cross-Sectional Questionnaire", 'orgStudyIdInfo': {'id': 'Zhongshan-HHY-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Severe complications following radical gastrectomy', 'type': 'PROCEDURE', 'description': 'The respondents are limited to surgeons who had previously experienced severe complications following radical gastrectomy as chief surgeons.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'HONGYONG HE, MD', 'role': 'CONTACT', 'email': 'he.hongyong@zs-hospital.sh.cn', 'phone': '15021383022'}], 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'hongyong he', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}