Global SurgeryNCT04450823
From Short-term Surgical Missions Towards Sustainable Partnerships
An observational study of Global Surgery and Medical Missions, run by Global Surgery Amsterdam at 1 site in Netherlands.
Trial summary
Introduction: Recently, the devastating consequences of neglected surgical care in global health became apparent with an estimated five billion people lacking access to safe surgical and anesthesia care. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Global Surgery, Medical Missions
- How many people
- 61 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2019to 30 Oct 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: An international group of members of foreign teams, that did participate in at least one short-term surgical mission in a hospital in a LMIC
Who may be able to join
- Members of foreign teams, that did participate in at least one short-term surgical mission in a hospital in a LMIC
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Global surgery amsterdam
Amsterdam, North Holland, 1105BD
About this study
Official title: From Short-term Surgical Missions Towards Sustainable Partnerships. A Survey Among Members of Foreign Teams
Introduction: Recently, the devastating consequences of neglected surgical care in global health became apparent with an estimated five billion people lacking access to safe surgical and anesthesia care. Traditionally, short-term surgical missions were the predominant strategy how surgical care was supported in Low- and Middle-Income Countries. Although surgical missions have been criticized in recent literature they are still being performed on a large scale. The aim of this study is to provide recommendations for persons and organizations involved in surgical mission on how to strengthen surgical care in LMICs in the future.
Method: An online survey was developed for members of foreign teams. Data was collected on 5 topics, consisting of: 1) basic characteristics of the missions, 2) main activities, 2) follow-up and reporting, 3) the local registration process for foreign teams and 4) collaboration with local stakeholders.
- Conditions
- Global Surgery, Medical Missions
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention study, survey amongst health workers
What is being measured
The primary outcome is the main question the study is designed to answer.
Q7: Country Where the Last Mission Took Place
Answer on the question: What was the country where your last mission took place?
Measured: approximately 20 minutes
Q8: Name of the Place and Hospital Where the Last Mission Took Place
List with names of the places and hospitals where the last mission took place
Measured: approximately 20 minutes
Q9: Number of Participants Per Organization
Name of the organization that supported the last mission of the participant
Measured: approximately 20 minutes
Q10: Countries Where the NGOs Are Based
List of countries where the supporting NGOs of the last mission are based
Measured: approximately 20 minutes
Q11: Importance of Potential Activities
Points provided (1-4) for four potential activities of a visiting team (more points = more important activity) The points provided by all participants are summed per specific activity and the total scores are compared
The four potential activities are:
- Treat patients yourself
- Provide surgical equipment and consumables for the local team
- Provide free treatment
- Facilitate teaching of local staff
Scale with importance of potential activities. Maximum score: 4x58 = 232
Measured: approximately 20 minutes
Q12: Activities That Where Missing in Question 11.
Respondents that were missing this activity as an option in question 11
Total number of respondents that were missing an activity: 29
Activities that were missing:
- Financial collaboration
- Advocacy
- Academic collaboration
- Sustainability
- Collaboration with local staff
- Follow-up
Measured: approximately 20 minutes
Q13. Medical Registration is Required in the Host Country
Medical registration in the host country is required for specialists performing short-term reconstructive missions
Participants of the survey were asked what they think of this statement:
- Strongly agree
- Agree
- Neither agree nor disagree
- Disagree
- Strongly disagree
Measured: approximately 20 minutes
Q14: The Process of Obtaining Medical Registration Was Straightforward
The Process of Obtaining Medical Registration Was Straightforward
Participants of the survey were asked what they think of this statement:
- Strongly agree
- Agree
- Neither agree nor disagree
- Disagree
- Strongly disagree
Measured: approximately 20 minutes
Q15: Collaboration
What can you say about the collaboration between authorities in LMICs and visiting surgical teams?
Participants of the survey were asked to choose one of the following answers on this question:
- collaboration is present but improvement is needed
- there is no collaboration and it should be developed as a priority
- collaboration has no benefits nor disadvantages
- collaboration will likely be more harmful than beneficial for the mission
Measured: approximately 20 minutes
Q16. What Should Have a Higher Priority in the Hospital of Your Last Mission?
What should have a higher priority in the hospital of your last mission ?
Respondents were asked to choose on the these two answers:
Teaching in anesthesia care or teaching in surgical care
Measured: approximately 20 minutes
Q17. A Structured Follow-up Strategy is Required
A structured follow-up strategy (>6 months) of patients is required for short-term reconstructive surgical missions.
Participants of the survey were asked what they think of this statement:
- Strongly agree
- Agree
- Neither agree nor disagree
- Disagree
- Strongly disagree
Measured: approximately 20 minutes
Q18. One Month After the Mission, an Official Report is Recommended
One month after the mission, an official report on the outcome including all complications encountered is recommended for all missions.
Participants of the survey were asked what they think of this statement:
- Strongly agree
- Agree
- Neither agree nor disagree
- Disagree
- Strongly disagree
Measured: approximately 20 minutes
Q19. A Written Long-term Strategy is Recommended at the Start of a New Project.
A written long-term strategy (>5 years) with clear goals, developed by the visiting team and the local actors together, is recommended at the start of a new project.
Participants of the survey were asked what they think of this statement:
- Strongly agree
- Agree
- Neither agree nor disagree
- Disagree
- Strongly disagree
Measured: approximately 20 minutes
Q20. Suggestions to Improve the Impact of Short Term Reconstructive Missions.
What would you suggest to improve the impact of short term reconstructive missions?
The answers were categorized and the three most mentioned categories are:
- Teaching of local staff
- Follow-up
- Building sustainable partnerships
The three activities were mentioned in total 68 times in the comments The distribution among the three categories is shown below
Measured: approximately 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start1 Jun 2019
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Global SurgeryStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global Surgery Amsterdam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthijs Botman, Global Surgery Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450823
- Sponsor's protocol ID
- 2020-01
- Status last verified
- Nov 2020
- First submitted
- 20 Jun 2020
- Last updated
- 19 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared anonymously on this platform as requested by the journal of submission (int,. journal of surgery)
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Short-term Surgical Missions Towards Sustainable Partnerships. A Survey Among Members of Foreign Teams
- ClinicalTrials.gov ID
- NCT04450823
- Acronym / sponsor ID
- 2020-01
- Conditions
- Global Surgery, Medical Missions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Global Surgery AmsterdamUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Posted 5 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: Recently, the devastating consequences of neglected surgical care in global health became apparent with an estimated five billion people lacking access to safe surgical and anesthesia care. Traditionally, short-term surgical missions were the predominant strategy how surgical care was supported in Low- and Middle-Income Countries. Although surgical missions have been criticized in recent literature they are still being performed on a large scale. The aim of this study is to provide recommendations for persons and organizations involved in surgical mission on how to strengthen surgical care in LMICs in the future.
Method: An online survey was developed for members of foreign teams. Data was collected on 5 topics, consisting of: 1) basic characteristics of the missions, 2) main activities, 2) follow-up and reporting, 3) the local registration process for foreign teams and 4) collaboration with local stakeholders.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- An international group of members of foreign teams, that did participate in at least one short-term surgical mission in a hospital in a LMIC
Key inclusion criteria (1 listed)
- Members of foreign teams, that did participate in at least one short-term surgical mission in a hospital in a LMIC
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| no interventionno intervention study, survey amongst health workers | Other | – |
Primary outcome
Q7: Country Where the Last Mission Took Place
Time frame: approximately 20 minutes
Answer on the question: What was the country where your last mission took place?
Q8: Name of the Place and Hospital Where the Last Mission Took Place
Time frame: approximately 20 minutes
List with names of the places and hospitals where the last mission took place
Q9: Number of Participants Per Organization
Time frame: approximately 20 minutes
Name of the organization that supported the last mission of the participant
Q10: Countries Where the NGOs Are Based
Time frame: approximately 20 minutes
List of countries where the supporting NGOs of the last mission are based
Q11: Importance of Potential Activities
Time frame: approximately 20 minutes
Points provided (1-4) for four potential activities of a visiting team (more points = more important activity) The points provided by all participants are summed per specific activity and the total scores are compared The four potential activities are: * Treat patients yourself * Provide surgical equipment and consumables for the local team * Provide free treatment * Facilitate teaching of local staff Scale with importance of potential activities. Maximum score: 4x58 = 232
Q12: Activities That Where Missing in Question 11.
Time frame: approximately 20 minutes
Respondents that were missing this activity as an option in question 11 Total number of respondents that were missing an activity: 29 Activities that were missing: * Financial collaboration * Advocacy * Academic collaboration * Sustainability * Collaboration with local staff * Follow-up
Q13. Medical Registration is Required in the Host Country
Time frame: approximately 20 minutes
Medical registration in the host country is required for specialists performing short-term reconstructive missions Participants of the survey were asked what they think of this statement: * Strongly agree * Agree * Neither agree nor disagree * Disagree * Strongly disagree
Q14: The Process of Obtaining Medical Registration Was Straightforward
Time frame: approximately 20 minutes
The Process of Obtaining Medical Registration Was Straightforward Participants of the survey were asked what they think of this statement: * Strongly agree * Agree * Neither agree nor disagree * Disagree * Strongly disagree
Q15: Collaboration
Time frame: approximately 20 minutes
What can you say about the collaboration between authorities in LMICs and visiting surgical teams? Participants of the survey were asked to choose one of the following answers on this question: * collaboration is present but improvement is needed * there is no collaboration and it should be developed as a priority * collaboration has no benefits nor disadvantages * collaboration will likely be more harmful than beneficial for the mission
Q16. What Should Have a Higher Priority in the Hospital of Your Last Mission?
Time frame: approximately 20 minutes
What should have a higher priority in the hospital of your last mission ? Respondents were asked to choose on the these two answers: Teaching in anesthesia care or teaching in surgical care
Q17. A Structured Follow-up Strategy is Required
Time frame: approximately 20 minutes
A structured follow-up strategy (>6 months) of patients is required for short-term reconstructive surgical missions. Participants of the survey were asked what they think of this statement: * Strongly agree * Agree * Neither agree nor disagree * Disagree * Strongly disagree
Q18. One Month After the Mission, an Official Report is Recommended
Time frame: approximately 20 minutes
One month after the mission, an official report on the outcome including all complications encountered is recommended for all missions. Participants of the survey were asked what they think of this statement: * Strongly agree * Agree * Neither agree nor disagree * Disagree * Strongly disagree
Q19. A Written Long-term Strategy is Recommended at the Start of a New Project.
Time frame: approximately 20 minutes
A written long-term strategy (>5 years) with clear goals, developed by the visiting team and the local actors together, is recommended at the start of a new project. Participants of the survey were asked what they think of this statement: * Strongly agree * Agree * Neither agree nor disagree * Disagree * Strongly disagree
Q20. Suggestions to Improve the Impact of Short Term Reconstructive Missions.
Time frame: approximately 20 minutes
What would you suggest to improve the impact of short term reconstructive missions? The answers were categorized and the three most mentioned categories are: * Teaching of local staff * Follow-up * Building sustainable partnerships The three activities were mentioned in total 68 times in the comments The distribution among the three categories is shown below
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared anonymously on this platform as requested by the journal of submission (int,. journal of surgery)
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Global Surgery and Medical Missions, run by Global Surgery Amsterdam at 1 site in Netherlands.
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: finished, as of the sponsor's last update on 19 Dec 2020. 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 Netherlands. 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?
Yes. Results are posted in the registry (first posted 5 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Q7: Country Where the Last Mission Took Place (time frame: approximately 20 minutes). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2020.