Cold Knife Versus Monopolar Electrosurgery in Abdominal Incisions

Not Applicable

• Conditions: Electrosurgery Versus Scalpel
• Interventions: Procedure: electrosurgery will be used for abdominal incision; Procedure: scalpel will be used for abdominal incision

• Registration Number: NCT04236401
• Lead Sponsor: Al-Azhar University

Brief Summary

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

• 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.

Study Timeline

• Study First Submitted: 2019-12-23
• Study First Submitted QC: 2020-01-20
• Study First Posted: 2020-01-22
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05
• Study Start: 2020-03
• Primary Completion: 2021-03
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
electrosurgery will be used inanterior abdominal wall incision	electrosurgery will be used for abdominal incision	to perform benign gynecological conditions , surgeon will need to open anterior wall electrosurgically.
scalpel will be used in abdominal wall incision	scalpel will be used for abdominal incision	to perform benign gynecological conditions , surgeon will need to open anterior wall sharply.

Primary Outcome Measures

Name	Time	Method
Wound infection	after surgery till primary healing of the wound, an average of 15 days after operation	rate of infection in wound after surgery as inflammation, seroma, heamatoma, gapping, sepsis or fever
Wound incision time	at the beginning of each surgery	measure time needed to open anterior abdominal wall in minutes by stopwatch

Secondary Outcome Measures

Name	Time	Method
Postoperative pain (pain score 2-4 hr postoperative).	during first 4 hours after surgery	using Visual Analogue Scale; the higher scores mean worse outcome
Wound-related blood loss	after opening anterior abdominal wall during each surgery	by weighing towel before and after abdominal wall incision / grams
number of participants with bad scar formation or keloid	through study completion, an average of 1.25 year	scar condition evaluation after complete healing of the wound. early healing after 15 days of the surgery and after complete healing after 45 days of the surgery
Amount of Analgesia needed during 1st 12 hr after surgery .	first 12 hours after surgery	dose of analgesia needed