Diathermy vs Scalpel in Abdominal Incision in Women Undergoing CS

NCT05462418 | Unknown

• 1 other identifier: AN2022-7
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Incision, Surgical

Keywords

Diathermy; scalpel; cesarean section; obese

Outcome Measures

Primary Outcomes (1)

• blood loss

  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

Study Arms (2)

diathermy group

ACTIVE COMPARATOR

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

scalpel

ACTIVE COMPARATOR

patients had their incisions completed using the surgical scalpel till we reach the parietal peritoneum.

Procedure: scalpel

Interventions

electrosurgery PROCEDURE

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.

Also known as: diathermy

diathermy group

scalpel PROCEDURE

patients had their incisions completed using the surgical scalpel till we reach the parietal peritoneum.

scalpel

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of medicine - Cairo university

Cairo, Kasr El Ainy, 11562, Egypt

RECRUITING

MeSH Terms

Conditions

Surgical Wound; Fever; Obesity

Interventions

Electrosurgery; Diathermy; Laser Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Hyperthermia, Induced; Therapeutics; Ablation Techniques

Study Officials

• Mohammed A Taymour, MD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

waleed M El-khayat, MD

CONTACT

01005135542; waleed_elkhyat@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 18, 2022
• Study Start: July 15, 2022
• Primary Completion: January 15, 2023
• Study Completion: February 15, 2023
• Last Updated: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)