Mental HealthNCT05782205
Surgeons' Mental Distress and Risks After Severe Complications Following Radical Gastrectomy
An observational study of Mental Health, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mental Health
- What is being tested?
- Severe complications following radical gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 31 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Enrolled as many surgeons as possible within the research time
Who may be able to join
- General and/or gastrointestinal surgeons who experienced severe complications after radical gastrectomy.
Who cannot join
- Other conditions that do not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
HONGYONG HE, MD, 15021383022, he.hongyong@zs-hospital.sh.cn
About this study
Official title: Surgeons' Mental Distress and Risks After Severe Complications Following Radical Gastrectomy in China: a Nationwide Cross-Sectional Questionnaire
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.
Gastric 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.
Surgeons 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.
- Conditions
- Mental Health
- Being tested
- Severe complications following radical gastrectomy
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Severe complications following radical gastrectomyProcedure or surgery
The respondents are limited to surgeons who had previously experienced severe complications following radical gastrectomy as chief surgeons.
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgeons' mental health
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.
Measured: June 01, 2023 to August 31, 2024.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start1 Jun 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hongyong he, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782205
- Sponsor's protocol ID
- Zhongshan-HHY-01
- Status last verified
- Nov 2023
- First submitted
- 9 Mar 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37158145
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgeons' Mental Distress and Risks After Severe Complications Following Radical Gastrectomy in China: a Nationwide Cross-Sectional Questionnaire
- ClinicalTrials.gov ID
- NCT05782205
- Acronym / sponsor ID
- Zhongshan-HHY-01
- Conditions
- Mental Health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Gastric 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.
Surgeons 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Enrolled as many surgeons as possible within the research time
Key inclusion criteria (1 listed)
- General and/or gastrointestinal surgeons who experienced severe complications after radical gastrectomy.
Key exclusion criteria (1 listed)
- Other conditions that do not meet the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Severe complications following radical gastrectomyThe respondents are limited to surgeons who had previously experienced severe complications following radical gastrectomy as chief surgeons. | Procedure or surgery | – |
Primary outcome
Surgeons' mental health
Time frame: June 01, 2023 to August 31, 2024.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Derived from this study: PubMed 37158145He 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgeons' mental health (time frame: June 01, 2023 to August 31, 2024.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05782205, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.