Clinical trial NCT06032637: Best Incision in Cesarean Section of Obese Women
Official title: Difference Between Pfannenstiel Incision and Higher Transverse Supra Umbilical Incision, During Elective Cesarean Section in Morbidly Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Cesarean Section Complications
Keywords: elective cesarean section
morbid obesity
Pfannenstiel incision
Transverse supra-umbilical incision
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this comparative clinical trial is to compare Pfannenstiel incision and higher transverse supra umbilical incision techniques during elective cesarean section in morbidly obese patients. The main questions it aims to answer are:

Is there a difference in operative time between the two incision techniques? Is there a difference in estimated blood loss between the two techniques? Is there a difference in post-operative pain scores between the two techniques? Is there a difference in wound complication rates between the two techniques? Participants will be randomly assigned to receive either a Pfannenstiel incision or a higher transverse supra umbilical incision during their scheduled cesarean delivery.

Researchers will compare the Pfannenstiel incision group to the higher transverse supra umbilical incision group to see if there are differences in operative time, blood loss, post-operative pain, and wound complications.

Detailed description: This randomized controlled trial will enroll 60 morbidly obese pregnant patients scheduled for elective cesarean delivery at gestational age ≥37 weeks. Morbid obesity will be defined as pre-pregnancy body mass index ≥40 kg/m2.

Patients will be randomly allocated to one of two groups (30 patients per group):

Group 1 (Pfannenstiel group): Patients will undergo a transverse infraumbilical skin incision 2-3 cm above the symphysis pubis, followed by transverse incision of the anterior rectus sheath in the same line as the skin incision, blunt digital separation of the rectus muscles, and transverse uterine incision in the lower segment.

Group 2 (Supra-umbilical transverse group): Patients will undergo a transverse skin incision halfway between the umbilicus and xiphoid process, followed by transverse incision of the anterior rectus sheath in the same line, blunt digital separation of the rectus muscles, and transverse uterine incision in the lower segment.

The primary outcome measures will be operative time, estimated blood loss, post-operative pain scores, and wound complication rates. Secondary outcomes will include length of hospital stay, patient satisfaction scores, and cosmetic results.

Eligibility criteria: Inclusion Criteria:

* Female patients aged between 20 and 40 years.
* Singleton pregnancy.
* Gestational age ≥ 37 weeks.
* Scheduled for elective cesarean delivery.
* Morbid obesity, defined as pre-pregnancy body mass index (BMI) ≥ 40 kg/m2.
* Willing and able to provide informed consent.
* Able to adhere to study procedures and follow-up schedule.

Exclusion Criteria:

* Emergency cesarean delivery.
* Multiple gestation (twins, triplets, etc)
* Placenta previa or vasa previa.
* History of more than 1 previous cesarean delivery.
* HIV, hepatitis B/C infection.
* Current anticoagulation therapy.
* Immune-compromised conditions.
* Premature rupture of membranes.
* Pre-existing skin conditions affecting the abdomen.
* Inability to provide informed consent.

Primary outcomes:
measure: Rate of surgical site wound infection
timeFrame: 4 weeks after the surgery.
Secondary outcomes:
measure: Operative time
timeFrame: during the surgery
measure: Hospital length of stay
timeFrame: From day of surgery to discharge, up to 8 weeks.
measure: Estimated blood loss
timeFrame: during the procedure
measure: Postoperative pain
timeFrame: From end of surgery through 4 weeks postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Hussein University Hospital
Study officials:
affiliation: Al-Azhar University
name: Muhamed A Alhagrasy, M.D.
role: PRINCIPAL_INVESTIGATOR
References: