FAUCS Surgery: Learning Curve for Resident

NCT04155177 | Withdrawn

• 1 other identifier: 36211361
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Caesarean; Training

Keywords

Caesarean; surgery; training; obstetrics

Outcome Measures

Primary Outcomes (1)

• 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

  through study completion, an average of 1 year

Secondary Outcomes (4)

• operative time

  through study completion, an average of 1 year

• neonatal acid base balance

  immediately after birth

• new born overall condition

  5 minutes after birth

• calculated blood loss

  the day and 24 hours after surgery

Study Arms (3)

begining of curriculum

trainees in obstetrics and gynecology who have achieved less than 2 years of their hole curriculum

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

Procedure: training for french ambulatory caesarean section

Advanced

trainees in obstetrics and gynecology who have achieved at least 4 years of their hole curriculm

Procedure: training for french ambulatory caesarean section

Interventions

training for french ambulatory caesarean section PROCEDURE

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; begining of curriculum; mid curriculum

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• trainee in obstetrics and gynecology.
• trainee subscribed for a training programm in the suty unit during the study period

You may not qualify if:

• 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

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Kaouther Dimassi

Tunis, Marsa, Tunisia

Location

Study Officials

• kaouther dimassi, MD

  University Tunis El Manar , Faculty of medicine Tunis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: November 7, 2019
• Study Start: March 30, 2021
• Primary Completion: January 3, 2022
• Study Completion: March 30, 2022
• Last Updated: May 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)