Transverse Supraumbilical Versus Pfannenstiel Incision For Cesarean Section In Morbidly Obese Women

Transverse Supraumbilical Versus Pfannenstiel Incision For Cesarean Section In Morbidly Obese Women "A Randomized Controlled Trial"

cesarean section is one of the most common operative procedures performed in modern obstetrics, that become increasingly common in both developed and developing countries for a variety of reasons today, thus any useful refinement in the operative technique, however minimal, is likely to yield substantial benefits.

In morbidly obese women with a panniculus, the supraumbilical incision is a new technique that showed definite advantages over the Pfannenstiel incision that will avoid burying the wound under a large panniculus and affords excellent abdominal exposure, less blood loss, less post-operative pain, earlier ambulation, and shorter hospital stay. All these advantages were attributed to minimal tissue manipulation.

Study Overview

• Status: Recruiting
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Procedure: Transverse supraumbilical incision; Procedure: Pfannenstiel Incision

Detailed Description

The prevalence of obesity has reached pandemic proportions across nations. Morbid obesity has a dramatic impact on pregnancy outcomes. Cesarean section in these women poses many surgical, anesthetic, and logistical challenges.

The rapid upswing in obesity prevalence across nations, ages, and ethnic groups has reached alarming and pandemic proportions.

The prevalence of morbid obesity (BMI>40 kg/m2) has increased by 50% between 2000 and 2005, with 8% of women in the reproductive age group being morbidly obese.

The percentage of women with a body mass index (BMI) of 50 Kg/m2 or more has increased five-fold in 20 years. Obesity is currently the most prevalent health threat the world over and its influence on general health is rapidly increasing.

The incidence of pregnancy-related pathology is higher in obese patients. Obstetricians are often confronted with difficult decisions when such patients are about to give birth. Indeed, in obese patients, labor is induced twice as frequently and vaginal delivery has to be interrupted more frequently due to an abnormal fetal heart rate or fetopelvic disproportion.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Arafa, MSc; Phone Number: 01022728663; Email: mohamedarafa1991@gmail.com
• Study Contact Backup: Name: Mohamed Hamed, MD; Phone Number: 01226067272

Study Locations

• Egypt
  • Cairo, Egypt, 11865
    • Recruiting
    • Ain shams university maternity hospital
    • Contact: Mohamed Arafa, MSc
    • Contact: Mohamed Hamed, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients presenting with morbid obesity (BMI > 40)
• Patients with an abdominal panniculus covering the supra pubic skin crease.
• Patients with a singleton pregnancy.
• All indications for elective cesarean section.
• Hemoglobin ≥ 10 g/dl.
• Since obesity is a disease associated commonly with co-morbidities such as diabetes mellitus, hypertension and sometimes chest problem these conditions will not be excluded, despite being significant factors that may affect wound healing and this will be analyzed in subgroups.
• Preoperative glycemic control (HbA1C level < 7 percent) for women with diabetes.

Exclusion Criteria:

• Antepartum Hemorrhage and placenta previa (more bleeding and operative time anticipated will interfere with the interpretation of operative date)
• Drugs intake that affects bleeding or tissue healing e.g., anti-coagulants, immunosuppressive drugs and chronic use of steroids (more than 14 days pre-operative).
• Multiple gestation (higher blood loss is anticipated).
• Patients diagnosed with intra amniotic infections (infections increases bleeding and incidence for post-operative infections).
• Patients with (HELLP syndrome) hemolysis, elevated liver enzymes and low platelets or bleeding disorders (the need for blood and blood products is higher than average).
• Patients with bleeding disorders or auto immune diseases (both affects bleeding and time needed for hemostasis as well as tissue healing).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transverse supraumbilical incision; The skin incision will be performed as a straight transverse skin incision 3-5cm above the umbilicus after maximum retraction of the panniculus caudally using two towel clips, to facilitate the approach to the lower uterine segment.	Procedure: Transverse supraumbilical incision; The skin incision will be performed as a straight transverse skin incision 3-5cm above umbilicus after maximum retraction the panniculus caudally using two towel clips, to facilitate the approach to the lower uterine segment The skin incision is a transverse upward concavity, typically initiated two finger-breadths above the symphysis pubis and extended in the direction of the anterior superior iliac spine below and medial to it about (2 - 3 cm) .
Experimental: Pfannenstiel Incision; The skin incision is a transverse upward concavity, typically initiated two finger breadths above the symphysis pubis and extended in the direction of the anterior superior iliac spine below and medial to it about (2 - 3 cm).	Procedure: Pfannenstiel Incision; The skin incision is a transverse upward concavity, typically initiated two finger-breadths above the symphysis pubis and extended in the direction of the anterior superior iliac spine below and medial to it about (2 - 3 cm).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean operative time	measurement of intra-operative times in minutes	during the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Intra-operative blood loss	By comparing pre-operative Hemoglobin with values taken 24 hours after the operation.	during the procedure
Occurrence of Post-operative Surgical site infection	The participants will be scheduled for a return visit after 7 days for removal of the sutures and recording of any signs of surgical site infection (hotness, tenderness, exudation, pus discharge).	7 days
Occurrence of surgical complications	observation of intraoperative visceral or vascular injuries	during the operation
Mean hospital stay	The time between the operation and discharge from hospital	3 days postoperatively
VAS score of pain	The severity of postoperative pain was assessed using the Visual Analogue Scale (VAS will be evaluated postoperatively and every 2 hours during the first 6 hours and then every 6 hours for the next 24 hours postoperatively). VAS is a 0 -10 scale in which 0 means that the patient feels no pain and 10 means that the patient is in maximal pain.	24 hours
Mean Intra-operative blood loss	comparing pre-operative Hematocrit values with values taken 24 hours after the operation.	During the procedure

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital
• Investigators: Principal Investigator: Mohamed Hamed, MD, Ain Shams Maternity Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: May 7, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 07052022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No