NCT04450823

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
1 month until next milestone

Results Posted

Study results publicly available

August 5, 2020

Completed
Last Updated

December 19, 2020

Status Verified

November 1, 2020

Enrollment Period

5 months

First QC Date

June 20, 2020

Results QC Date

July 2, 2020

Last Update Submit

November 25, 2020

Conditions

Outcome Measures

Primary Outcomes (14)

  • Q7: Country Where the Last Mission Took Place

    Answer on the question: What was the country where your last mission took place?

    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

    approximately 20 minutes

  • Q9: Number of Participants Per Organization

    Name of the organization that supported the last mission of the participant

    approximately 20 minutes

  • Q10: Countries Where the NGOs Are Based

    List of countries where the supporting NGOs of the last mission are based

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    approximately 20 minutes

Interventions

no intervention study, survey amongst health workers

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Members of foreign teams, that did participate in at least one short-term surgical mission in a hospital in a LMIC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Global surgery amsterdam

Amsterdam, North Holland, 1105BD, Netherlands

Location

Limitations and Caveats

An important limitation of this study is that most of the respondents are medical doctors from HICs. Another possible 'selection bias' that could have occurred concerns (over-) representation of experts from the Netherlands.

Results Point of Contact

Title
Dr Matthijs Botman
Organization
Global Surgery Amsterdam

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 20, 2020

First Posted

June 30, 2020

Study Start

June 1, 2019

Primary Completion

October 30, 2019

Study Completion

October 30, 2019

Last Updated

December 19, 2020

Results First Posted

August 5, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

Individual participant data will be shared anonymously on this platform as requested by the journal of submission (int,. journal of surgery)

Shared Documents
STUDY PROTOCOL
Time Frame
ASAP

Locations