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FAUCS Surgery: Learning Curve for Resident

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ClinicalTrials.gov Identifier: NCT04155177
Recruitment Status : Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Kaouther Dimassi, University Tunis El Manar

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.


Condition or disease Intervention/treatment
Caesarean Training Procedure: training for french ambulatory caesarean section

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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Learning Curve of the "French Ambulatory Caesarean Section"
Estimated Study Start Date : January 30, 2020
Estimated Primary Completion Date : January 3, 2021
Estimated Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Group/Cohort Intervention/treatment
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

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
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.


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





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. neonatal acid base balance [ Time Frame: immediately after birth ]
    cord blood gaz

  3. 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 .

  4. calculated blood loss [ Time Frame: the day and 24 hours after surgery ]
    changes in hematocrites levels before and after a surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155177


Contacts
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Contact: kaouther dimassi, MD 52550697 ext +216 kaouther.dimassi@fmt.utm.tn
Contact: ahmed halouani, MD 50527325 ext +216 halouani.a@gmail.com

Locations
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Tunisia
Kaouther Dimassi
Tunis, Marsa, Tunisia
Contact: kaouther dimassi, MD         
Sponsors and Collaborators
University Tunis El Manar
Investigators
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Principal Investigator: kaouther dimassi, MD University Tunis El Manar , Faculty of medicine Tunis
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Responsible Party: Kaouther Dimassi, Associate professor, University Tunis El Manar
ClinicalTrials.gov Identifier: NCT04155177    
Other Study ID Numbers: 36211361
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaouther Dimassi, University Tunis El Manar:
Caesarean
surgery
training
obstetrics