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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04155177
Other study ID # 36211361
Secondary ID
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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