Diathermy vs Scalpel in Abdominal Incision in Women Undergoing CS

July 14, 2022 updated by: ahmed nagy shaker ramadan, Cairo University

Diathermy Versus Scalpel in the Transverse Abdominal Incision in Primigravida Obese Women Undergoing Cesarean Section

Cesarean section is surging worldwide. For an extended period of surgical practice, the scalpel has been well-known as a gold-standard tool for making surgical incisions. The diathermy, electrocautery, is a substitute.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Kasr El Ainy
      • Cairo, Kasr El Ainy, Egypt, 11562
        • Recruiting
        • Faculty of medicine - Cairo university
        • Contact:
          • mohamed T aneis, MD
          • Phone Number: 202 23653269
        • Principal Investigator:
          • waleed M El khyat, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with BMI 30- 40 Kg/m2.
  • Women pregnant with singletons and planned to have a repeat elective lower-segment CS at 38-39 weeks' gestation due to having had one previous CS.
  • Women pregnant with singletons and planned to deliver by lower-segment CS at 38-39 weeks' gestation for the first time (primi-section) due to obstetric indication.

Exclusion Criteria:

  • Cases with coagulopathies eg. Hemophilia, von Willebrand disease
  • Cases on anti-coagulant therapy eg. Heparin, warfarin
  • Cases with chronic diseases expected to affect wound healing, such as diabetes, hypertension, liver diseases, chronic anemia, and renal impairment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: diathermy group
Patients' incisions are completed using the unipolar diathermy from Whiteline until we reach the parietal peritoneum (cutting the Whiteline then coagulating until reaching the peritoneum). The used diathermy frequency was 50-70 MHz.
Procedure: electrosurgery
incisions completed using use the unipolar diathermy from Whiteline till we reach the parietal peritoneum (cutting the Whiteline then coagulation till reaching the peritoneum). The used diathermy frequency was 50-70 MHz.
Other Names:
  • diathermy
Active Comparator: scalpel
patients had their incisions completed using the surgical scalpel till we reach the parietal peritoneum.
Procedure: scalpel
patients had their incisions completed using the surgical scalpel till we reach the parietal peritoneum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood loss
Time Frame: 30 min
assess and compare intraoperative blood loss between both studied groups. This was done using visualization technique detecting numbers of fully soaked pads used during the incision.
30 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Mohammed A Taymour, MD, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2022

Primary Completion (Anticipated)

January 15, 2023

Study Completion (Anticipated)

February 15, 2023

Study Registration Dates

First Submitted

July 14, 2022

First Submitted That Met QC Criteria

July 14, 2022

First Posted (Actual)

July 18, 2022

Study Record Updates

Last Update Posted (Actual)

July 18, 2022

Last Update Submitted That Met QC Criteria

July 14, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN2022-7

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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