FAUCS Surgery: Learning Curve for Resident

NCT ID: NCT04155177

Last Updated: 2021-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-30

Study Completion Date

2022-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Caesarean Training

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

begining of curriculum

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

training for french ambulatory caesarean section

Intervention Type 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.

mid curriculum

trainees in obstetrics and gynecology who have achieved at least 2 years and less than 4 years of their hole curriculum

training for french ambulatory caesarean section

Intervention Type 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

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

training for french ambulatory caesarean section

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

training for french ambulatory caesarean section

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Tunis El Manar

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kaouther Dimassi

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

kaouther dimassi, MD

Role: PRINCIPAL_INVESTIGATOR

University Tunis El Manar , Faculty of medicine Tunis

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kaouther Dimassi

Tunis, Marsa, Tunisia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Tunisia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

36211361

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.