CaesareanNCT04155177
FAUCS Surgery: Learning Curve for Resident
An observational study of Caesarean and Training, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
In the last decades, caesarean section (CS) rates are getting higher in all over the world. This encourages us to improve operative techniques. In January 2018, investigators have introduced in the study unit: The French Ambulatory C section (FAUCS). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- What is being tested?
- training for french ambulatory caesarean section
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteTunisia
- Study dates
- 30 Mar 2021to 30 Mar 2022
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: all the included participants will be enrolled in three groups : * First group : trainees in obstetrics and gynecology who have achieved less than 2 years of their hole curriculum * Second group : trainees who have acieved at least 2 years and less than 4 years of the curriculum * third group : trainees who have achieved at least 4 years of their curriculum
Who may be able to join
- trainee in obstetrics and gynecology.
- trainee subscribed for a training programm in the suty unit during the study period
Who cannot join
- Trainee in obstetrics and gynecology subscribed in atraining program elswhere from the sutudy unit during the study period
- trainee who refused to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Learning Curve of the "French Ambulatory Caesarean Section"
In the last decades, caesarean section (CS) rates are getting higher in all over the world.
This encourages us to improve operative techniques. In January 2018, investigators have introduced in the study unit: The French Ambulatory C section (FAUCS). This innovative approach appeares to provide a shorter recovery time, with a hospital discharge the day after surgery in 90% and then a better experience of childbirth.
The diffusion of this technique requires its integration to the curriculum of residency.
In this study, investigators will determine the mean number of procedures needed for trainees to master FAUCS.
Read the detailed description
Caesarean section (CS) is of the most commonly performed operations worldwide. This encourages a permanent search to improve the operative techniques for a better childbirth experience. The MisgavLadach (MLC), caesarean section is the gold standard for caesarean section. Thus so, it is included During the first years of obstetrics curriculum.
In January 2018, investigators have introduced The French Ambulatory C section (FAUCS) in the study unit. It is an innovative approach for CS. combining a left paramedian incision , an extra peritoneal access to the uterus and a purse-string double-layer closure of the uterus. Since that date, two doctors practice it regularly. However, the diffusion of this technique requires its integration into the curriculum of residency. Currently, there is no study on the learning procedure of FAUCS.
In our study, investigators will determine the mean number of procedures needed for trainees to master FAUCS.
Once the resident will master the procedure, investigators will study his skills evolution every 5 surgeries performed alone.
- Being tested
- training for french ambulatory caesarean section
- Keywords
- Caesarean, surgery, training, obstetrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
training for french ambulatory caesarean sectionProcedure or surgery
The participant will be first invited to consult a theoretical support and a video treating on FAUCS.
After that, he will be asked to be the first assistant, in a FAUCS procedure with one of the two senior surgeons assigned for the study.
In a second step, the trainee will have to perform all the steps of the FAUCS, assisted by one of the two senior surgeons . During each surgery, Operative time will be measured, while an evaluation on four stages according to the Zwisch model of supervision will performed by the senior surgeons .
Once, the two seniors agree on the highest level assessment for the resident, he will be allowed to operate alone FAUCS procedures and will be evaluated by the measurement of operating times, the neonatal outcomes and the occurrence or not of complications.
finally, total number of FAUCS procedures required for each resident in order to master the technique will be determined.
| Study group | Role | What they receive |
|---|---|---|
| begining of curriculum | trainees in obstetrics and gynecology who have achieved less than 2 years of their hole curriculum Receives: Procedure: training for french ambulatory caesarean section | |
| mid curriculum | trainees in obstetrics and gynecology who have achieved at least 2 years and less than 4 years of their hole curriculum Receives: Procedure: training for french ambulatory caesarean section | |
| Advanced | trainees in obstetrics and gynecology who have achieved at least 4 years of their hole curriculm Receives: Procedure: training for french ambulatory caesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of surgical procedure needed for a trainee to master the FAUCS.
Number of surgical procedure needed for a trainee to acheive the highest evaluation
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
operative time
time elapsed from skin incision and the end of surgery will be measured in minutes
Measured: through study completion, an average of 1 year
neonatal acid base balance
cord blood gaz
Measured: immediately after birth
new born overall condition
Apgar score ( The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are summarized using words chosen to form an ackronym (Appearance, Pulse, Grimace, Activity, Respiration).he test is generally done at 1 and 5 minutes after birth and may be repeated later if the score is and remains low. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts .
Measured: 5 minutes after birth
calculated blood loss
changes in hematocrites levels before and after a surgery
Measured: the day and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start30 Mar 2021 (estimated)
- Primary completion3 Jan 2022 (estimated)
- Study completion30 Mar 2022 (estimated)
Why it stopped: no participants because of the sars cov 2 pandemic there is no volonteer to be recruited for the lurning curve . all the residents are busy working in COVID UNITS
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaesareanStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaouther Dimassi, University Tunis El Manar
- Investigators
- kaouther dimassi, MD, Principal investigator, University Tunis El Manar , Faculty of medicine Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155177
- Sponsor's protocol ID
- 36211361
- Status last verified
- Apr 2021
- First submitted
- 15 Oct 2019
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Curve of the "French Ambulatory Caesarean Section"
- ClinicalTrials.gov ID
- NCT04155177
- Acronym / sponsor ID
- 36211361
- Keywords
- Caesarean, surgery, training, obstetrics
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no participants because of the sars cov 2 pandemic there is no volonteer to be recruited for the lurning curve . all the residents are busy working in COVID UNITS
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 30 Mar 2021 (estimated)
- Primary completion
- 3 Jan 2022 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 7 Nov 2019 (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.
In the last decades, caesarean section (CS) rates are getting higher in all over the world.
This encourages us to improve operative techniques. In January 2018, investigators have introduced in the study unit: The French Ambulatory C section (FAUCS). This innovative approach appeares to provide a shorter recovery time, with a hospital discharge the day after surgery in 90% and then a better experience of childbirth.
The diffusion of this technique requires its integration to the curriculum of residency.
In this study, investigators will determine the mean number of procedures needed for trainees to master FAUCS.
Detailed description
Caesarean section (CS) is of the most commonly performed operations worldwide. This encourages a permanent search to improve the operative techniques for a better childbirth experience. The MisgavLadach (MLC), caesarean section is the gold standard for caesarean section. Thus so, it is included During the first years of obstetrics curriculum.
In January 2018, investigators have introduced The French Ambulatory C section (FAUCS) in the study unit. It is an innovative approach for CS. combining a left paramedian incision , an extra peritoneal access to the uterus and a purse-string double-layer closure of the uterus. Since that date, two doctors practice it regularly. However, the diffusion of this technique requires its integration into the curriculum of residency. Currently, there is no study on the learning procedure of FAUCS.
In our study, investigators will determine the mean number of procedures needed for trainees to master FAUCS.
Once the resident will master the procedure, investigators will study his skills evolution every 5 surgeries performed alone.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| begining of curriculum | – | Procedure: training for french ambulatory caesarean sectiontrainees in obstetrics and gynecology who have achieved less than 2 years of their hole curriculum |
| mid curriculum | – | Procedure: training for french ambulatory caesarean sectiontrainees in obstetrics and gynecology who have achieved at least 2 years and less than 4 years of their hole curriculum |
| Advanced | – | Procedure: training for french ambulatory caesarean sectiontrainees in obstetrics and gynecology who have achieved at least 4 years of their hole curriculm |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- all the included participants will be enrolled in three groups : * First group : trainees in obstetrics and gynecology who have achieved less than 2 years of their hole curriculum * Second group : trainees who have acieved at least 2 years and less than 4 years of the curriculum * third group : trainees who have achieved at least 4 years of their curriculum
Key inclusion criteria (2 listed)
- trainee in obstetrics and gynecology.
- trainee subscribed for a training programm in the suty unit during the study period
Key exclusion criteria (2 listed)
- Trainee in obstetrics and gynecology subscribed in atraining program elswhere from the sutudy unit during the study period
- trainee who refused to participate in the study
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 |
|---|---|---|
| training for french ambulatory caesarean sectionThe participant will be first invited to consult a theoretical support and a video treating on FAUCS. After that, he will be asked to be the first assistant, in a FAUCS procedure with one of the two senior surgeons assigned for the study. In a second step, the trainee will have to perform all the steps of the FAUCS, assisted by one of the two senior surgeons . During each surgery, Operative time will be measured, while an evaluation on four stages according to the Zwisch model of supervision will performed by the senior surgeons . Once, the two seniors agree on the highest level assessment for the resident, he will be allowed to operate alone FAUCS procedures and will be evaluated by the measurement of operating times, the neonatal outcomes and the occurrence or not of complications. finally, total number of FAUCS procedures required for each resident in order to master the technique will be determined. | Procedure or surgery | Advanced, begining of curriculum, mid curriculum |
Primary outcome
Number of surgical procedure needed for a trainee to master the FAUCS.
Time frame: through study completion, an average of 1 year
Number of surgical procedure needed for a trainee to acheive the highest evaluation
4 secondary outcomes
operative time
Time frame: through study completion, an average of 1 year
neonatal acid base balance
Time frame: immediately after birth
new born overall condition
Time frame: 5 minutes after birth
calculated blood loss
Time frame: the day and 24 hours after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Individual participant dataSharing planned: No
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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.
kaouther dimassi, MD principal investigator
University Tunis El Manar , Faculty of medicine Tunis
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 Caesarean and Training, run by University Tunis El Manar at 1 site in Tunisia.
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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 5 May 2021. 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 Tunisia. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of surgical procedure needed for a trainee to master the FAUCS. (time frame: through study completion, an average of 1 year). 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 5 May 2021; AzTrials last refreshed its copy on 31 Oct 2026.