Best Incision in Cesarean Section of Obese Women

Morbid Obesity Clinical Trial

Official title:

Difference Between Pfannenstiel Incision and Higher Transverse Supra Umbilical Incision, During Elective Cesarean Section in Morbidly Obese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06032637
• Other study ID #: Obstet1222
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: February 2024
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 30, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section Complications
• Morbid Obesity
• Obesity, Morbid
• Surgical Wound

Intervention

Procedure:
• Pfannenstiel incision
Patients randomized to the supra-umbilical transverse incision arm will receive a transverse skin incision halfway between the umbilicus and xiphoid process, extending laterally to the semilunar lines. The subcutaneous tissue will be bluntly dissected until the anterior rectus sheath is exposed. A transverse incision will be made through the rectus sheath in line with the skin incision, avoiding injury to the superior epigastric vessels. The rectus muscles will be split manually using blunt dissection. The peritoneum will be incised transversely and the hysterotomy extended laterally to deliver the fetus. The visceral peritoneum will not be closed. The rectus muscles will not be re-approximated. The subcutaneous tissue will not be irrigated but closed if over 2cm depth. The skin will be closed with non-absorbable suture subcuticularly.
• Supra-umbilical transverse incision
Patients randomized to the supra-umbilical transverse incision arm will receive a transverse skin incision 3-4cm above the umbilicus, extending laterally to the semilunar lines, without panniculus retraction. The subcutaneous tissue will be bluntly dissected until the anterior rectus sheath is exposed. The rectus sheath will be incised transversely using electrocautery for hemostasis, avoiding injury to the superior epigastric vessels. The rectus muscles will be split manually along the midline using blunt dissection. The peritoneum will be transversely incised and the hysterotomy extended laterally to deliver the fetus. The visceral peritoneum will not be closed. The rectus muscles will not be re-approximated. The subcutaneous tissue will not be irrigated but closed if over 2cm depth. The skin will be closed with non-absorbable suture subcuticularly.

Locations

Country	Name	City	State
Egypt	Al-Hussein University Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of surgical site wound infection	Surgical site infections will be assessed at the cesarean incision site and tracked for 4 weeks postoperatively. Wound infection will be defined as purulent drainage from the incision, positive culture, and/or at least two of the following signs or symptoms: pain or tenderness, localized swelling, redness, or heat. The 4-week timeframe starts on the day of surgery (day 0) and ends 28 days postoperatively. Wound infections occurring up to 4 weeks after surgery will be captured and recorded as the primary outcome measure. Wound assessments will be performed daily during the hospital stay, at the post-op visit around 2 weeks, and at the 4-week follow-up visit.	4 weeks after the surgery.
Secondary	Operative time	Operative time will be defined as the time from skin incision to complete wound closure. It will be recorded in minutes by a study investigator observing each procedure.	during the surgery
Secondary	Hospital length of stay	Hospital length of stay will be defined as the number of days from surgery until discharge from the hospital.	From day of surgery to discharge, up to 8 weeks.
Secondary	Estimated blood loss	Estimated blood loss will be assessed by the anesthesiologist and surgeon at the end of the procedure, based on the amount of blood in the suction canister and blood-soaked sponges/lap pads.	during the procedure
Secondary	Postoperative pain	Postoperative pain will be assessed using a visual analog scale (VAS) of 0-10, with 0 being no pain and 10 being worst possible pain. Patients will rate their pain level at set intervals after surgery - immediately after recovery room discharge, daily while inpatient, and at 2 weeks and 4 weeks postop during follow-up visits.	From end of surgery through 4 weeks postoperatively