Best Incision in Cesarean Section of Obese Women

NCT06032637 | Completed

• 1 other identifier: Obstet1222
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity; Cesarean Section Complications

Keywords

elective cesarean section; morbid obesity; Pfannenstiel incision; Transverse supra-umbilical incision

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Operative time

  during the surgery

• Hospital length of stay

  From day of surgery to discharge, up to 8 weeks.

• Estimated blood loss

  during the procedure

• Postoperative pain

  From end of surgery through 4 weeks postoperatively

Study Arms (2)

Pfannenstiel incision

ACTIVE COMPARATOR

Patients randomized to the Pfannenstiel incision arm will undergo a transverse skin incision 2-3cm above the symphysis pubis. Subcutaneous tissue will be dissected until 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 inferior epigastric arteries. Rectus muscles will be separated manually along midline using blunt dissection. The peritoneum will be incised transversely and the hysterotomy extended laterally with uterine traction to deliver fetus. The visceral peritoneum will not be closed. Rectus muscles will not be re-approximated. Subcutaneous tissue will not be irrigated. Subcutaneous tissue will be closed if over 2cm depth. Skin will be closed with non-absorbable suture subcuticularly.

Procedure: Pfannenstiel incision

Supra-Umbilical

EXPERIMENTAL

Patients randomized to the supra-umbilical transverse incision arm will undergo a transverse skin incision halfway between the umbilicus and xiphoid process, extending laterally to the semilunar lines. Subcutaneous tissue will be bluntly dissected until 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. Rectus muscles will be split manually along midline using blunt dissection. The peritoneum will be incised transversely and the hysterotomy extended laterally with uterine traction to deliver fetus. The visceral peritoneum will not be closed. Rectus muscles will not be re-approximated. Subcutaneous tissue will not be irrigated. Subcutaneous tissue will be closed if over 2cm depth. Skin will be closed with non-absorbable suture subcuticularly.

Procedure: Supra-umbilical transverse incision

Interventions

Pfannenstiel incision PROCEDURE

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.

Pfannenstiel incision

Supra-umbilical transverse incision PROCEDURE

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.

Supra-Umbilical

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: This study will enroll only female participants, as the surgical procedures being compared are specific to cesarean delivery. Only pregnant patients who are scheduled to undergo elective cesarean section will be included. This study is restricted to women only given the gender-specific nature of pregnancy and childbirth. Patients must be female sex at birth with intact uteri in order to be eligible. Transgender male patients and individuals with no female reproductive organs will be excluded. Enrollment is limited to cisgender women only.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Hussein University Hospital

Cairo, 11633, Egypt

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Muhamed A Alhagrasy, M.D.

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer and consultant at Obstetrics and Gynecology Department.

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 13, 2023
• Study Start: August 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 30, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)