Cold Knife Versus Monopolar Electrosurgery in Abdominal Incisions

Al-Azhar University

Status: Unknown

Conditions: Electrosurgery Versus Scalpel

Treatments: Procedure: scalpel will be used for abdominal incision; Procedure: electrosurgery will be used for abdominal incision

Study type: Interventional

Funder types: Other

Identifiers

NCT04236401

Electrosurgery

Details and patient eligibility

About

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.

Full description

• 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups

electrosurgery will be used inanterior abdominal wall incision

Other group

Description:

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

Treatment:

Procedure: electrosurgery will be used for abdominal incision

scalpel will be used in abdominal wall incision

Other group

Description:

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

Treatment:

Procedure: scalpel will be used for abdominal incision