Electrosurgery Versus ScalpelNCT04236401
Cold Knife Versus Monopolar Electrosurgery in Abdominal Incisions
A study testing electrosurgery will be used for abdominal incision and scalpel will be used for abdominal incision in people with Electrosurgery Versus Scalpel, run by Al-Azhar University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Electrosurgery Versus Scalpel
- What is being tested?
- electrosurgery will be used for abdominal incision and scalpel will be used for abdominal incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Cold Knife Versus Monopolar Electrosurgery for Abdominal Incisions ( Clinical Trial )
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.
Read the 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.
- Conditions
- Electrosurgery Versus Scalpel
- Being tested
- electrosurgery will be used for abdominal incision, scalpel will be used for abdominal incision
- Keywords
- electrosurgery, scalpel, abdominal incision
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrosurgery will be used for abdominal incisionProcedure or surgery
electrosurgery will be used to open anterior abdominal wall and electrosurgery will be used for heamostasis also
scalpel will be used for abdominal incisionProcedure or surgery
scalpel will be used for abdominal wall incision and thread will be used for haemostsis
| Study group | Role | What they receive |
|---|---|---|
| electrosurgery will be used inanterior abdominal wall incision | Other | to perform benign gynecological conditions , surgeon will need to open anterior wall electrosurgically. Receives: Procedure: electrosurgery will be used for abdominal incision |
| scalpel will be used in abdominal wall incision | Other | to perform benign gynecological conditions , surgeon will need to open anterior wall sharply. Receives: Procedure: scalpel will be used for abdominal incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound incision time
measure time needed to open anterior abdominal wall in minutes by stopwatch
Measured: at the beginning of each surgery
Wound infection
rate of infection in wound after surgery as inflammation, seroma, heamatoma, gapping, sepsis or fever
Measured: after surgery till primary healing of the wound, an average of 15 days after operation
Secondary outcomes (4)
Postoperative pain (pain score 2-4 hr postoperative).
using Visual Analogue Scale; the higher scores mean worse outcome
Measured: during first 4 hours after surgery
Amount of Analgesia needed during 1st 12 hr after surgery .
dose of analgesia needed
Measured: first 12 hours after surgery
Wound-related blood loss
by weighing towel before and after abdominal wall incision / grams
Measured: 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
Measured: through study completion, an average of 1.25 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study startMar 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electrosurgery Versus ScalpelStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Esmail Borhamy Khalaf, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236401
- Sponsor's protocol ID
- Electrosurgery
- Status last verified
- Feb 2020
- First submitted
- 23 Dec 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Knife Versus Monopolar Electrosurgery for Abdominal Incisions ( Clinical Trial )
- ClinicalTrials.gov ID
- NCT04236401
- Acronym / sponsor ID
- Electrosurgery
- Conditions
- Electrosurgery Versus Scalpel
- Keywords
- electrosurgery, scalpel, abdominal incision
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electrosurgery will be used inanterior abdominal wall incision | Other | Procedure: electrosurgery will be used for abdominal incisionto perform benign gynecological conditions , surgeon will need to open anterior wall electrosurgically. |
| scalpel will be used in abdominal wall incision | Other | Procedure: scalpel will be used for abdominal incisionto perform benign gynecological conditions , surgeon will need to open anterior wall sharply. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrosurgery will be used for abdominal incisionelectrosurgery will be used to open anterior abdominal wall and electrosurgery will be used for heamostasis also | Procedure or surgery | electrosurgery will be used inanterior abdominal wall incision |
| scalpel will be used for abdominal incisionscalpel will be used for abdominal wall incision and thread will be used for haemostsis | Procedure or surgery | scalpel will be used in abdominal wall incision |
Primary outcome
Wound incision time
Time frame: at the beginning of each surgery
measure time needed to open anterior abdominal wall in minutes by stopwatch
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
4 secondary outcomes
Postoperative pain (pain score 2-4 hr postoperative).
Time frame: during first 4 hours after surgery
Amount of Analgesia needed during 1st 12 hr after surgery .
Time frame: first 12 hours after surgery
Wound-related blood loss
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing electrosurgery will be used for abdominal incision and scalpel will be used for abdominal incision in people with Electrosurgery Versus Scalpel, run by Al-Azhar University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound incision time (time frame: at the beginning of each surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.