- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04155177
FAUCS Surgery: Learning Curve for Resident
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.
Study Overview
Status
Intervention / Treatment
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 Type
Contacts and Locations
Study Locations
-
-
Marsa
-
Tunis, Marsa, Tunisia
- Kaouther Dimassi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
Description
Inclusion Criteria:
- trainee in obstetrics and gynecology.
- trainee subscribed for a training programm in the suty unit during the study period
Exclusion Criteria :
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
begining of curriculum
trainees in obstetrics and gynecology who have achieved less than 2 years of their hole curriculum
|
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. |
mid curriculum
trainees in obstetrics and gynecology who have achieved at least 2 years and less than 4 years of their hole curriculum
|
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. |
Advanced
trainees in obstetrics and gynecology who have achieved at least 4 years of their hole curriculm
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
operative time
Time Frame: through study completion, an average of 1 year
|
time elapsed from skin incision and the end of surgery will be measured in minutes
|
through study completion, an average of 1 year
|
neonatal acid base balance
Time Frame: immediately after birth
|
cord blood gaz
|
immediately after birth
|
new born overall condition
Time Frame: 5 minutes after birth
|
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 .
|
5 minutes after birth
|
calculated blood loss
Time Frame: the day and 24 hours after surgery
|
changes in hematocrites levels before and after a surgery
|
the day and 24 hours after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: kaouther dimassi, MD, University Tunis El Manar , Faculty of medicine Tunis
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 36211361
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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