Comparison of FAUCS vs. Misgav Ladach

Bnai Zion Medical Center

Status: Unknown

Conditions: Ambulation Difficulty; Pain, Postoperative

Treatments: Procedure: Misgav-Ladach; Procedure: French Abulatory Cesrean Section

Study type: Interventional

Funder types: Other

Identifiers

NCT03812406

FAUCS

Details and patient eligibility

About

This study aims to compare two techniques for performing a cesarean delivery: Misgav Ladach versus French Ambulatory Cesarean Section (FAUCS). The second techniques has been claimed to reduce post-operative pain, the need for analgesics, and reduce the time for ambulation. Such comparison has not been done so far, and this study will examined if indeed the FAUCS techniques offers any advantages.

Full description

The FAUCS technique for performing a cesarean section has been described by a French group several years ago, and is claimed to reduce postoperative pain and increase ambulation. With this technique, after making the transverse skin incision, the fascia is opened vertically and to the left of the linea alba. The left rectus abdominis muscle is then pushed laterally, and the abdominal cavity is entered. The uterine incision in performed as usual. Due to the reduced incision size, a special spatula is used to facilitate extraction of the fetal head in some cases. No urinary catheter is used during or after the operation, and fluid administration is restricted during the procedure. The patient is encouraged to get out of bed 3-4 hours post surgery. This technique for performing a cesarean section will be compared with the traditional (Misgav Ladach technique) in terms of post-operative pain, need for analgesics, ambulation, neonatal outcome, and perioperative complications.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients scheduled for a cesarean section
• term pregnancy: 37-42 weeks
• singleton pregnancy
• age 18 and above
• patients capable of signing an informed consent

Exclusion criteria

• multiple pregnancy
• emergency cesarean
• previous 3 cesareans and above
• placenta accreta
• uterine myomas in the lower segment
• fetal growth restriction
• fetal anemia
• preeclampsia
• women scheduled for general anesthesia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

FAUCS

Experimental group

Description:

Patients undergoing a cesarean section using the FAUCS technique

Treatment:

Procedure: French Abulatory Cesrean Section

Control

Active Comparator group

Description:

Patients undergoing a cesarean section using the traditional (Misgav-Ladach) technique

Treatment:

Procedure: Misgav-Ladach