Appendicitis AcuteNCT07091110
Efficacy of LigaSure Versus Harmonic Scalpel US in Laparoscopic Appendectomy in Management of Acute Appendicitis
An observational study of Appendicitis Acute, run by Zagazig University at 1 site in Egypt.
Trial summary
Background Acute appendicitis is the most frequent abdominal surgical emergency worldwide, peaking in incidence between the second and third decade of life. Appendectomy was the only treatment for appendicitis for more than a century, and it is still the most common treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Appendicitis Acute
- What is being tested?
- laparoscopic appendectomy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Jan 2025
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: This is a prospective comparative study for a total of 60 patients participated in this study, which ran from January 2023 to January 2025. Patients were complaining of acute right lower abdominal pain, after clinical examination, laboratory and radiological investigations diagnosed as acute appendicitis.
Who may be able to join
- Inclusion criteria This study included 26 female and 34 male patients. All patients presented with clinically, laboratory, and radiographically confirmed acute appendicitis. All of whom were between the ages of 18 and 60.
Who cannot join
- We excluded patients with complicated acute appendicitis, such as appendicular mass or abscess, patients with a history of previous multiple open abdominal surgeries, patients with economic factors, and also patients who preferred conventional, open appendectomy to the laparoscopic removal approach.
Trial locations and contacts
1 site in 1 country.
About this study
Background Acute appendicitis is the most frequent abdominal surgical emergency worldwide, peaking in incidence between the second and third decade of life. Appendectomy was the only treatment for appendicitis for more than a century, and it is still the most common treatment. The surgical treatment for appendicitis is an appendectomy, which can be performed laparoscopically or openly. The purpose of the current study is to determine and measure the safety and effectiveness of laparoscopic appendectomy with LigaSure and harmonic US scalpels.
Patients and methods:
This research was carried out from January 2023 to January 2025, involved 60 patients who complained of acute lower abdominal pain in their right side, and were diagnosed with suspected acute appendicitis. Two groups of patients were formed: Group A had an appendectomy performed laparoscopically using a harmonic US scalpel, and group B underwent a laparoscopic appendectomy using LigaSure.
Read the detailed description
Study Design This is a prospective comparative study for a total of 60 patients participated in this study, which ran from January 2023 to January 2025. Patients were complaining of acute right lower abdominal pain, after clinical examination, laboratory and radiological investigations diagnosed as acute appendicitis. Patients were randomized by the closed envelope method into 2 equal groups; 30 patients for each. Group A (laparoscopic appendectomy using harmonic US scalpel and endoloop) and group B (laparoscopic appendectomy using LigaSure plus endoloop).
Study Approval Ethical approval for this study was granted by the Institutional Review Board of the Zagazig University, with an IRB registration number is ZU-IRB#1419/17-6-2025.
Inclusions criteria This study included 26 female and 34 male patients. All patients presented with clinically, laboratory and radiographically confirmed acute appendicitis. All of whom were between the ages of 18 and 60.
Exclusions criteria We excluded patients with complicated acute appendicitis as appendicular mass or abscess, patients with history of previous multiple open abdominal surgeries, patients with economic factors and also patients who preferred conventional, open appendectomy to laparoscopic removal approach.
Examination, diagnosis and Workup protocol The patient's complete medical history (including a typical recent non-neglected right lower abdomen or periumbilical discomfort, nausea/vomiting, anorexia, or a low grade fever, etc.) and physical examination (right iliac fossa tenderness or guarding with a positive Mc-Burney's sign, cough test, etc.) were used to make the clinical diagnosis of non-complicated acute appendicitis. Laboratory tests such as the complete blood count (CBC), C-reactive protein (CRP), pregnancy test for female patients in the childbearing age range, etc., were needed for each patient and interpreted. Additionally, all patients underwent an ultrasound, either with or without a pelvi-abdomen CT scan with contrast, to confirm the diagnosis, rule out other potential causes of acute abdomen, and-most importantly-rule out patients with complicated appendicitis, such as those with phlegmon, generalized peritonitis, or appendicular abscess.
Following an explanation on the diagnosis, the steps involved in the laparoscopic procedure, the benefits, dangers, and potential issues, all patients who satisfied the criteria for surgery were given written consent. The patient was placed on IV fluids, prophylactic broad-spectrum IV antibiotics (Ceftriaxone 2g IV), and NPO as part of the operation, which was completed within 24 hours of the diagnosis and management.
The Surgical Procedure The procedure was carried out with the patient in a supine position under general anesthesia. After the abdomen was prepared and wrapped, three trocars were placed inside of it. Using a laparoscopic Veress needle, the first trocar (10mm) for pneumoperitoneum (figure 1) was inserted in the periumbilical region. In the right or the left iliac fossa (according to the intraoperative position of the appendix and the surgeon preference), is the second trocar 5 mm functioning port. Third trocar 5 mm functioning port located above the pubic area (figure 2).
Diagnose the appendix, examine for any pathology, and then begin the procedure. Ligation of the base using endoloops(figure 3), coagulation, sealing, and division of the mesoappendix using either ligaSure (figure 4) or Harmonic US (figure 5) as the energy source. Under direct vision, all of the trocars were extracted while the abdomen was deflated. Layers of skin closure using Monocryl 4/0 for both modules of the procedure. Following surgery, all specimens were sent for histological analysis.
The operating nurse noted the duration of each group's operation. Twelve hours after surgery, all patients were put on a liquid diet and given little sips of water. Only in cases where the appendix was significantly inflamed or perforated were antibiotics administered for at least three days after surgery. Early ambulation was advised for all patients in order to assist bowel movements. Both groups of patients were released from the hospital 1 to 2 days following surgery.
Statistical analysis The categorical variables were presented as a number (%), while the continuous variables were presented as the mean ± SD \& median (range). Using the Shapiro-Wilk test, continuous variables were examined for normality. Separate samples two groups of regularly distributed data were compared using the Student's t-test, and non-normally distributed variables were compared using the Mann Whitney U test. When appropriate, Fisher's exact test or Pearson's chi-square test were used to compare the percentage of categorical variables. Every test had two tails. It was deemed statistically significant when the P-value was less than 0.05. SPSS version 22.0 for Windows (IBM Corp., Armonk, NY, USA) was used for all statistics
- Conditions
- Appendicitis Acute
- Being tested
- laparoscopic appendectomy
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic appendectomyProcedure or surgery
laparoscopic appendectomy
| Study group | Role | What they receive |
|---|---|---|
| A | laparoscopic appendectomy using harmonic US scalpel and endoloop Receives: Procedure: laparoscopic appendectomy | |
| B | Laparoscopic appendectomy using LigaSure plus endoloop Receives: Procedure: laparoscopic appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the average range of operating time for both groups
Depending on the degree of difficulties experienced, the average range of operating time for both groups was reported.
Measured: from January 2023 to January 2025
Secondary outcomes (3)
intraoperative complications
In both groups, any intraoperative complications, such as haemorrhage, bowel or organ damage is recorded
Measured: from January 2023 to January 2025
conversion to open surgery
any case is discovered to have difficult appendicitis during surgery, either with early appendicular phlegmon or with an appendicular abscess with minor collections, conversion to open surgery is documented.
Measured: from January 2023 to January 2025
postoperative complications
any case with postoperative complications, as bleeding, infection, or collection is reported
Measured: from January 2023 to January 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Jan 2023
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendicitis AcuteStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed I Farid, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091110
- Sponsor's protocol ID
- ZU-IRB#1419/17-6-2025
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of LigaSure Versus Harmonic Scalpel US in Laparoscopic Appendectomy in Management of Acute Appendicitis
- ClinicalTrials.gov ID
- NCT07091110
- Acronym / sponsor ID
- ZU-IRB#1419/17-6-2025
- Conditions
- Appendicitis Acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 29 Jul 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.
Background Acute appendicitis is the most frequent abdominal surgical emergency worldwide, peaking in incidence between the second and third decade of life. Appendectomy was the only treatment for appendicitis for more than a century, and it is still the most common treatment. The surgical treatment for appendicitis is an appendectomy, which can be performed laparoscopically or openly. The purpose of the current study is to determine and measure the safety and effectiveness of laparoscopic appendectomy with LigaSure and harmonic US scalpels.
Patients and methods:
This research was carried out from January 2023 to January 2025, involved 60 patients who complained of acute lower abdominal pain in their right side, and were diagnosed with suspected acute appendicitis. Two groups of patients were formed: Group A had an appendectomy performed laparoscopically using a harmonic US scalpel, and group B underwent a laparoscopic appendectomy using LigaSure.
Detailed description
Study Design This is a prospective comparative study for a total of 60 patients participated in this study, which ran from January 2023 to January 2025. Patients were complaining of acute right lower abdominal pain, after clinical examination, laboratory and radiological investigations diagnosed as acute appendicitis. Patients were randomized by the closed envelope method into 2 equal groups; 30 patients for each. Group A (laparoscopic appendectomy using harmonic US scalpel and endoloop) and group B (laparoscopic appendectomy using LigaSure plus endoloop).
Study Approval Ethical approval for this study was granted by the Institutional Review Board of the Zagazig University, with an IRB registration number is ZU-IRB#1419/17-6-2025.
Inclusions criteria This study included 26 female and 34 male patients. All patients presented with clinically, laboratory and radiographically confirmed acute appendicitis. All of whom were between the ages of 18 and 60.
Exclusions criteria We excluded patients with complicated acute appendicitis as appendicular mass or abscess, patients with history of previous multiple open abdominal surgeries, patients with economic factors and also patients who preferred conventional, open appendectomy to laparoscopic removal approach.
Examination, diagnosis and Workup protocol The patient's complete medical history (including a typical recent non-neglected right lower abdomen or periumbilical discomfort, nausea/vomiting, anorexia, or a low grade fever, etc.) and physical examination (right iliac fossa tenderness or guarding with a positive Mc-Burney's sign, cough test, etc.) were used to make the clinical diagnosis of non-complicated acute appendicitis. Laboratory tests such as the complete blood count (CBC), C-reactive protein (CRP), pregnancy test for female patients in the childbearing age range, etc., were needed for each patient and interpreted. Additionally, all patients underwent an ultrasound, either with or without a pelvi-abdomen CT scan with contrast, to confirm the diagnosis, rule out other potential causes of acute abdomen, and-most importantly-rule out patients with complicated appendicitis, such as those with phlegmon, generalized peritonitis, or appendicular abscess.
Following an explanation on the diagnosis, the steps involved in the laparoscopic procedure, the benefits, dangers, and potential issues, all patients who satisfied the criteria for surgery were given written consent. The patient was placed on IV fluids, prophylactic broad-spectrum IV antibiotics (Ceftriaxone 2g IV), and NPO as part of the operation, which was completed within 24 hours of the diagnosis and management.
The Surgical Procedure The procedure was carried out with the patient in a supine position under general anesthesia. After the abdomen was prepared and wrapped, three trocars were placed inside of it. Using a laparoscopic Veress needle, the first trocar (10mm) for pneumoperitoneum (figure 1) was inserted in the periumbilical region. In the right or the left iliac fossa (according to the intraoperative position of the appendix and the surgeon preference), is the second trocar 5 mm functioning port. Third trocar 5 mm functioning port located above the pubic area (figure 2).
Diagnose the appendix, examine for any pathology, and then begin the procedure. Ligation of the base using endoloops(figure 3), coagulation, sealing, and division of the mesoappendix using either ligaSure (figure 4) or Harmonic US (figure 5) as the energy source. Under direct vision, all of the trocars were extracted while the abdomen was deflated. Layers of skin closure using Monocryl 4/0 for both modules of the procedure. Following surgery, all specimens were sent for histological analysis.
The operating nurse noted the duration of each group's operation. Twelve hours after surgery, all patients were put on a liquid diet and given little sips of water. Only in cases where the appendix was significantly inflamed or perforated were antibiotics administered for at least three days after surgery. Early ambulation was advised for all patients in order to assist bowel movements. Both groups of patients were released from the hospital 1 to 2 days following surgery.
Statistical analysis The categorical variables were presented as a number (%), while the continuous variables were presented as the mean ± SD \& median (range). Using the Shapiro-Wilk test, continuous variables were examined for normality. Separate samples two groups of regularly distributed data were compared using the Student's t-test, and non-normally distributed variables were compared using the Mann Whitney U test. When appropriate, Fisher's exact test or Pearson's chi-square test were used to compare the percentage of categorical variables. Every test had two tails. It was deemed statistically significant when the P-value was less than 0.05. SPSS version 22.0 for Windows (IBM Corp., Armonk, NY, USA) was used for all statistics
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Procedure: laparoscopic appendectomylaparoscopic appendectomy using harmonic US scalpel and endoloop |
| B | – | Procedure: laparoscopic appendectomyLaparoscopic appendectomy using LigaSure plus endoloop |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This is a prospective comparative study for a total of 60 patients participated in this study, which ran from January 2023 to January 2025. Patients were complaining of acute right lower abdominal pain, after clinical examination, laboratory and radiological investigations diagnosed as acute appendicitis.
Key inclusion criteria (1 listed)
- Inclusion criteria This study included 26 female and 34 male patients. All patients presented with clinically, laboratory, and radiographically confirmed acute appendicitis. All of whom were between the ages of 18 and 60.
Key exclusion criteria (1 listed)
- We excluded patients with complicated acute appendicitis, such as appendicular mass or abscess, patients with a history of previous multiple open abdominal surgeries, patients with economic factors, and also patients who preferred conventional, open appendectomy to the laparoscopic removal approach.
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 appendectomylaparoscopic appendectomy | Procedure or surgery | A, B |
Primary outcome
the average range of operating time for both groups
Time frame: from January 2023 to January 2025
Depending on the degree of difficulties experienced, the average range of operating time for both groups was reported.
3 secondary outcomes
intraoperative complications
Time frame: from January 2023 to January 2025
conversion to open surgery
Time frame: from January 2023 to January 2025
postoperative complications
Time frame: from January 2023 to January 2025
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis Acute, run by Zagazig University at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the average range of operating time for both groups (time frame: from January 2023 to January 2025). 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 29 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.