Cold Knife Versus Monopolar Electrosurgery in Abdominal Incisions

NCT ID: NCT04236401

Last Updated: 2020-02-05

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-31

Study Completion Date

2021-05-31

Brief Summary

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the aim of work is to compare the early postoperative and late term wound complication rates between the scalpel and electrosurgery in patients with benign gynecological conditions undergoing abdominal incisions.

Detailed Description

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• Study Hypothesis: - Using electrosurgery decrease incision blood loss, decrease postoperative pain, decrease wound time incision, decrease analgesia requirements, doesn't increase wound sepsis.

Type of study: - Randomized controlled trial study (parallel group study with 1:1 randomization) will be conducted at gynecology department of Alzhraa University Hospital of faculty of Medicine for girls - Cairo within 1 year according to sample size. A computer randomization will be generated and held with one of the experimenter, and (n) of black and red card will be used for allocation concealment.

Participants at morning of the operation will be given information about the study aims and written consent will be taken.

Conditions

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Electrosurgery Versus Scalpel

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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electrosurgery will be used inanterior abdominal wall incision

to perform benign gynecological conditions , surgeon will need to open anterior wall electrosurgically.

Group Type OTHER

electrosurgery will be used for abdominal incision

Intervention Type PROCEDURE

electrosurgery will be used to open anterior abdominal wall and electrosurgery will be used for heamostasis also

scalpel will be used in abdominal wall incision

to perform benign gynecological conditions , surgeon will need to open anterior wall sharply.

Group Type OTHER

scalpel will be used for abdominal incision

Intervention Type PROCEDURE

scalpel will be used for abdominal wall incision and thread will be used for haemostsis

Interventions

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electrosurgery will be used for abdominal incision

electrosurgery will be used to open anterior abdominal wall and electrosurgery will be used for heamostasis also

Intervention Type PROCEDURE

scalpel will be used for abdominal incision

scalpel will be used for abdominal wall incision and thread will be used for haemostsis

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients scheduled for elective gynecological abdominal surgeries for benign diseases
* willing to participate in the study.
* The participants will receive 2 gm cephalosporines preoperative per hospital policy.

Exclusion Criteria

* History of receiving antibiotics during the preceding 7 days,
* chronic medical illness like diabetes, asthma or tuberculosis,
* patients have anemia,
* surgically scarred tissues,
* Immuno-compromised patients,
* pregnant patients,
* patients with pacemaker device,
* patients on anticoagulants therapy
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Shimaa Esmail Borhamy Khalaf

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Electrosurgery

Identifier Type: -

Identifier Source: org_study_id

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