Best Incision in Cesarean Section of Obese Women

NCT ID: NCT06032637

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-10-30

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.

Conditions

Morbid Obesity; Cesarean Section Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pfannenstiel incision

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.

Group Type: ACTIVE_COMPARATOR

Pfannenstiel incision

Intervention Type: 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.

Supra-Umbilical

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.

Group Type: EXPERIMENTAL

Supra-umbilical transverse incision

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy

lecturer and consultant at Obstetrics and Gynecology Department.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhamed A Alhagrasy, M.D.

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Locations

Al-Hussein University Hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Obstet1222

Identifier Type: -

Identifier Source: org_study_id