Electrosurgery Versus Scalpel
Conditions
Keywords
electrosurgery, scalpel, abdominal incision
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.
Interventions
PROCEDUREelectrosurgery will be used for abdominal incision
electrosurgery will be used to open anterior abdominal wall and electrosurgery will be used for heamostasis also
PROCEDUREscalpel will be used for abdominal incision
scalpel will be used for abdominal wall incision and thread will be used for haemostsis
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound incision time | at the beginning of each surgery | measure time needed to open anterior abdominal wall in minutes by stopwatch |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain (pain score 2-4 hr postoperative). | during first 4 hours after surgery | using Visual Analogue Scale; the higher scores mean worse outcome |
| Amount of Analgesia needed during 1st 12 hr after surgery . | first 12 hours after surgery | dose of analgesia needed |
| 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 |
Outcome results
None listed