- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04236401
Cold Knife Versus Monopolar Electrosurgery in Abdominal Incisions
Cold Knife Versus Monopolar Electrosurgery for Abdominal Incisions ( Clinical Trial )
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: electrosurgery will be used inanterior abdominal wall incision
to perform benign gynecological conditions , surgeon will need to open anterior wall electrosurgically.
|
electrosurgery will be used to open anterior abdominal wall and electrosurgery will be used for heamostasis also
|
Other: scalpel will be used in abdominal wall incision
to perform benign gynecological conditions , surgeon will need to open anterior wall sharply.
|
scalpel will be used for abdominal wall incision and thread will be used for haemostsis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wound incision time
Time Frame: at the beginning of each surgery
|
measure time needed to open anterior abdominal wall in minutes by stopwatch
|
at the beginning of each surgery
|
Wound infection
Time Frame: 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
|
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).
Time Frame: during first 4 hours after surgery
|
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 .
Time Frame: first 12 hours after surgery
|
dose of analgesia needed
|
first 12 hours after surgery
|
Wound-related blood loss
Time Frame: after opening anterior abdominal wall during each surgery
|
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
Time Frame: 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
|
through study completion, an average of 1.25 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Electrosurgery
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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