Cold Knife Versus Monopolar Electrosurgery in Abdominal Incisions

Al-Azhar University90 enrolled

Overview

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.

• 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Electrosurgery Versus Scalpel

Interventions

electrosurgery will be used for abdominal incisionPROCEDURE

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

scalpel will be used for abdominal incisionPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Wound incision time

measure time needed to open anterior abdominal wall in minutes by stopwatch

Time frame: at the beginning of each surgery

Wound infection

rate of infection in wound after surgery as inflammation, seroma, heamatoma, gapping, sepsis or fever

Time frame: after surgery till primary healing of the wound, an average of 15 days after operation

Secondary Outcomes

Postoperative pain (pain score 2-4 hr postoperative).

using Visual Analogue Scale; the higher scores mean worse outcome

Time frame: during first 4 hours after surgery

Amount of Analgesia needed during 1st 12 hr after surgery .

dose of analgesia needed

Time frame: first 12 hours after surgery

Wound-related blood loss

by weighing towel before and after abdominal wall incision / grams

Time frame: after opening anterior abdominal wall during each surgery

number of participants with bad scar formation or keloid

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

Time frame: through study completion, an average of 1.25 year

Data from ClinicalTrials.gov

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