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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Zagazig University Hospitals

    Zagazig, Sharqia Province

Other trials in Egypt

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

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 groups in NCT07091110
Study groupRoleWhat they receive
Alaparoscopic appendectomy using harmonic US scalpel and endoloop
Receives: Procedure: laparoscopic appendectomy
BLaparoscopic 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.

  1. 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)
  1. intraoperative complications

    In both groups, any intraoperative complications, such as haemorrhage, bowel or organ damage is recorded

    Measured: from January 2023 to January 2025

  2. 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

  3. 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.

  1. First posted29 Jul 2025
  2. Study start1 Jan 2023
  3. Primary completion1 Jan 2025
  4. Study completion1 Jan 2025

Resources

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)
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

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.

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