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

NCT05385276 | Unknown DMC

• 1 other identifier: 07052022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

• Mean operative time

  measurement of intra-operative times in minutes

  during the procedure

Secondary Outcomes (6)

• Mean Intra-operative blood loss

  during the procedure

• Occurrence of Post-operative Surgical site infection

  7 days

• Occurrence of surgical complications

  during the operation

• Mean hospital stay

  3 days postoperatively

• VAS score of pain

  24 hours

Study Arms (2)

Transverse supraumbilical incision

EXPERIMENTAL

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

Pfannenstiel Incision

EXPERIMENTAL

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

Interventions

Transverse supraumbilical incision PROCEDURE

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) .

Transverse supraumbilical incision

Pfannenstiel Incision PROCEDURE

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).

Pfannenstiel Incision

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, 11865, Egypt

RECRUITING

Study Officials

• Mohamed Hamed, MD

  Ain Shams Maternity Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Arafa, MSc

CONTACT

01022728663; mohamedarafa1991@gmail.com

Mohamed Hamed, MD

CONTACT

01226067272

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: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2022
• First Posted: May 23, 2022
• Study Start: May 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: February 1, 2023
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)