Diathermy vs Scalpel in Abdominal Incision in Women Undergoing CS

NCT ID: NCT05462418

Last Updated: 2022-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-15

Study Completion Date

2023-02-15

Brief Summary

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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.

Detailed Description

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Conditions

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Incision, Surgical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

electrosurgery

Intervention Type 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.

scalpel

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

Group Type ACTIVE_COMPARATOR

scalpel

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

scalpel

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

Intervention Type PROCEDURE

Other Intervention Names

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diathermy

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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ahmed nagy shaker ramadan

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammed A Taymour, MD

Role: STUDY_DIRECTOR

Cairo University

Locations

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faculty of medicine - Cairo university

Cairo, Kasr El Ainy, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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waleed M El-khayat, MD

Role: CONTACT

01005135542

Facility Contacts

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mohamed T aneis, MD

Role: primary

202 23653269

Other Identifiers

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AN2022-7

Identifier Type: -

Identifier Source: org_study_id

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