Diathermy vs Scalpel in Abdominal Incision in Women Undergoing CS

NCT05462418 — Not applicable, Unknown, 300 participants, Cairo University

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

Registry	NCT05462418
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, supportive care
Enrollment	300 (Estimated)
Sponsor	Cairo University (Other)
Conditions	Incision, Surgical
Interventions	electrosurgery, scalpel (Procedure)
Dates	start 2022-07-15, primary completion 2023-01-15 (estimated), completion 2023-02-15 (estimated), first posted 2022-07-18, last updated 2022-07-18
Locations	1 site in Egypt

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
diathermy group	Active comparator	Procedure: electrosurgery	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.
scalpel	Active comparator	Procedure: scalpel	patients had their incisions completed using the surgical scalpel till we reach the parietal peritoneum.

electrosurgery (Procedure), also known as diathermy: 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.
scalpel (Procedure): patients had their incisions completed using the surgical scalpel till we reach the parietal peritoneum.

+Outcome measures

Primary outcomes

blood loss [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.

+Eligibility

Sex: Female, ages: 20 Years to 40 Years

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.

+Locations (1)

Facility	City	Country	Status
faculty of medicine - Cairo university	Cairo, Kasr El Ainy	Egypt	Recruiting

+Investigators

Mohammed A Taymour, MD, Study director, Cairo University