Laparoscopic AppendectomyNCT06826651
Use of Bipolar Diathermy VS Clips in Laparoscopic Appendectomy
A study testing laparoscopic appendectomy, bipolar diathermy and clips closure in people with Laparoscopic Appendectomy and Bipolar Diathermy, run by Assiut University.
Trial summary
Acute Appendicitis is the most frequent acute pathological abdominal illness needing immediate surgery. The laparoscopic appendectomy (LA) has become more popular and is advised as the first course of treatment, particularly for female, obese, and elderly patients.LA can also give surgeons a greater field view and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Laparoscopic Appendectomy, Bipolar Diathermy
- What is being tested?
- laparoscopic appendectomy, bipolar diathermy and clips closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients admitted to AUH with uncomplicated acute appendicitis or chronic appendicitis
- Age group (18-70)
Who cannot join
- patients with complex appendicitis (appendicular mass, abscess, etc).
- patients who had the following conditions: cirrhosis with ascites, abdominal distention, and coagulation disorders, cardiac patients; shock upon arrival, a large ventral hernia, and inflammatory bowel disease
About this study
Official title: Thermal Sealing by Bipolar Diathermy Versus Clips Closure of Mesoappendix in Laparoscopic Appendectomy ..A Comparative Study
Acute Appendicitis is the most frequent acute pathological abdominal illness needing immediate surgery. The laparoscopic appendectomy (LA) has become more popular and is advised as the first course of treatment, particularly for female, obese, and elderly patients.LA can also give surgeons a greater field view and identification of other abdominal organs that can have different pathologies that could mimic the symptoms of acute appendicitis.The most crucial step in preventing major complications such postoperative bleeding, peritonitis, sepsis is sealing the mesoappendix. Due to this circumstance, surgeons are looking for alternative treatments for LA. The best technique for sealing mesoappendix should be affordable, practical, safe, and easy to apply technically. Extracorporeal sliding knots, intracorporeal ligations, endo-loops, nonabsorbable polymer clips (Hem-o-lock clips), hand-made loops, and Ligasure usage, and bipolar cautery division are some of the techniques utilized at LA to seal mesoappendix. According to studies, each of these techniques is secure and practicable.5 In this study, there is a comparative study between using Bipolar diathermy as a source of sealing and other mechanical closure techniques for mesoappendix To assess effect of energy source sealing of mesoappendix by using Bipolar diathermy in comparison to mechanical closure by clips as regard outcome and complications.
- Conditions
- Laparoscopic Appendectomy, Bipolar Diathermy
- Being tested
- laparoscopic appendectomy, bipolar diathermy, clips closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic appendectomyProcedure or surgery
By using laparoscopy, after achieving conclusive identification of the mesoappendix
bipolar diathermyProcedure or surgery
the mesoappendix coagulated using bipolar diathermy, then cut with scissor.
clips closureProcedure or surgery
mesoappendix will be divided between 3 clips, two placed distally and one proximally. The mesoappendix will be cut in between the clips.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Laparoscopic appendectomy, using of bipolar diathermy to coagulate mesoappendix Receives: Procedure: laparoscopic appendectomy; Procedure: bipolar diathermy |
| Group B | Experimental | laparoscopic appendectomy, using surgical clips in closure of mesoappendix Receives: Procedure: laparoscopic appendectomy; Procedure: clips closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative blood loss
amount of blood loss will be calcculated by number of towel used and aomunt of blood in sution
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic AppendectomyStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulrahman Samir Fahmy Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826651
- Sponsor's protocol ID
- Use of bipolar diathermy
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermal Sealing by Bipolar Diathermy Versus Clips Closure of Mesoappendix in Laparoscopic Appendectomy ..A Comparative Study
- ClinicalTrials.gov ID
- NCT06826651
- Acronym / sponsor ID
- Use of bipolar diathermy
- Conditions
- Laparoscopic Appendectomy, Bipolar Diathermy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 14 Feb 2025 (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.
Acute Appendicitis is the most frequent acute pathological abdominal illness needing immediate surgery. The laparoscopic appendectomy (LA) has become more popular and is advised as the first course of treatment, particularly for female, obese, and elderly patients.LA can also give surgeons a greater field view and identification of other abdominal organs that can have different pathologies that could mimic the symptoms of acute appendicitis.The most crucial step in preventing major complications such postoperative bleeding, peritonitis, sepsis is sealing the mesoappendix. Due to this circumstance, surgeons are looking for alternative treatments for LA. The best technique for sealing mesoappendix should be affordable, practical, safe, and easy to apply technically. Extracorporeal sliding knots, intracorporeal ligations, endo-loops, nonabsorbable polymer clips (Hem-o-lock clips), hand-made loops, and Ligasure usage, and bipolar cautery division are some of the techniques utilized at LA to seal mesoappendix. According to studies, each of these techniques is secure and practicable.5 In this study, there is a comparative study between using Bipolar diathermy as a source of sealing and other mechanical closure techniques for mesoappendix To assess effect of energy source sealing of mesoappendix by using Bipolar diathermy in comparison to mechanical closure by clips as regard outcome and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: laparoscopic appendectomy, Procedure: bipolar diathermyLaparoscopic appendectomy, using of bipolar diathermy to coagulate mesoappendix |
| Group B | Experimental | Procedure: laparoscopic appendectomy, Procedure: clips closurelaparoscopic appendectomy, using surgical clips in closure of mesoappendix |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients admitted to AUH with uncomplicated acute appendicitis or chronic appendicitis
- Age group (18-70)
Key exclusion criteria (2 listed)
- patients with complex appendicitis (appendicular mass, abscess, etc).
- patients who had the following conditions: cirrhosis with ascites, abdominal distention, and coagulation disorders, cardiac patients; shock upon arrival, a large ventral hernia, and inflammatory bowel disease
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 |
|---|---|---|
| laparoscopic appendectomyBy using laparoscopy, after achieving conclusive identification of the mesoappendix | Procedure or surgery | Group A, Group B |
| bipolar diathermythe mesoappendix coagulated using bipolar diathermy, then cut with scissor. | Procedure or surgery | Group A |
| clips closuremesoappendix will be divided between 3 clips, two placed distally and one proximally. The mesoappendix will be cut in between the clips. | Procedure or surgery | Group B |
Primary outcome
intraoperative blood loss
Time frame: baseline
amount of blood loss will be calcculated by number of towel used and aomunt of blood in sution
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
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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.
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 laparoscopic appendectomy, bipolar diathermy and clips closure in people with Laparoscopic Appendectomy and Bipolar Diathermy, run by Assiut 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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 14 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
intraoperative blood loss (time frame: baseline). 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 14 Feb 2025.