FAUCS Surgery: Learning Curve for Resident

Training Clinical Trial

Official title:

Learning Curve of the "French Ambulatory Caesarean Section"

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04155177
• Other study ID #: 36211361
• Status: Withdrawn
• Start date: March 30, 2021
• Est. completion date: March 30, 2022

Study information

• Verified date: April 2021
• Source: University Tunis El Manar
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 30, 2022
• Est. primary completion date: January 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Caesarean
• Training

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Tunisia	Kaouther Dimassi	Tunis	Marsa

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	operative time	time elapsed from skin incision and the end of surgery will be measured in minutes	through study completion, an average of 1 year
Secondary	neonatal acid base balance	cord blood gaz	immediately after birth
Secondary	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 .	5 minutes after birth
Secondary	calculated blood loss	changes in hematocrites levels before and after a surgery	the day and 24 hours after surgery