Cold Knife Versus Monopolar Electrosurgery in Abdominal Incisions

Study Overview
=================
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.

Official Title
-----------------
Cold Knife Versus Monopolar Electrosurgery for Abdominal Incisions ( Clinical Trial )

Conditions
-----------------
Electrosurgery Versus Scalpel

Intervention / Treatment
-----------------
* Procedure: electrosurgery will be used for abdominal incision
* Procedure: scalpel will be used for abdominal incision


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: electrosurgery will be used inanterior abdominal wall incision<br>to perform benign gynecological conditions , surgeon will need to open anterior wall electrosurgically. | Procedure: electrosurgery will be used for abdominal incision<br>* electrosurgery will be used to open anterior abdominal wall and electrosurgery will be used for heamostasis also<br>|
| Other: scalpel will be used in abdominal wall incision<br>to perform benign gynecological conditions , surgeon will need to open anterior wall sharply. | Procedure: scalpel will be used for abdominal incision<br>* scalpel will be used for abdominal wall incision and thread will be used for haemostsis<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain (pain score 2-4 hr postoperative). | using Visual Analogue Scale; the higher scores mean worse outcome | during first 4 hours after surgery | 
| Amount of Analgesia needed during 1st 12 hr after surgery . | dose of analgesia needed | first 12 hours after surgery | 
| Wound-related blood loss | by weighing towel before and after abdominal wall incision / grams | 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 | through study completion, an average of 1.25 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
electrosurgery, scalpel, abdominal incision