Laparoscopic AppendectomyNCT07129746
Comparison Between Metallic Clip Ligation and Suture Ligation of Appendicular Stump in Laparoscopic Appendectomy
A study testing Metallic clip ligation of the appendicular stump and Suture ligation of appendicular stump in people with Laparoscopic Appendectomy, run by Jinnah Hospital at 1 site in Pakistan.
Trial summary
Laparoscopic appendectomy is the standard procedure for acute appendicitis. Among the various steps of the procedure one of the rate limiting step is the ligation of the appendicular stump which can be done using suture material, metallic clips and hem o loks. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Laparoscopic Appendectomy
- What is being tested?
- Metallic clip ligation of the appendicular stump and Suture ligation of appendicular stump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Aug 2025to 20 Feb 2026
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Both genders, within the age bracket of 15 years - 60 years.
- With a BMI within the range of 18 - 28 kg/m2.
- With a diagnosis made by a consultant surgeon and the grade of appendicitis upto 3.
Who cannot join
- Patients with long standing comorbidities including chronic liver disease, diabetes mellitus, chronic kidney disease and hemorrhagic disorders.
- Patients taking anticoagulants, carrier of active cases of Hepatitis B, C and/or HIV.
- Patients on immunosuppression therapy. Diameter of appendicular stump of more than 10mm, perforated appendix, laparoscopic appendectomy converted to open appendectomy pelvic appendicitis and sub-hepatic appendicitis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Jinnah Hospital Lahore
Lahore, Punjab Province, 54000
MUHAMMAD SAUD IQBAL, 03029424346, saudiqbal08@gmail.com
Farooq Ahmad, MBBS, FCPS, FRCS, FACS, +92 3338022210, farooqahmadrana-s1@aimc.edu.pk
About this study
Official title: Comparison Between Metallic Clip Ligation and Suture Ligation of Appendicular Stump in Laparoscopic Appendectomy, a Randomized Control Trial
Laparoscopic appendectomy is the standard procedure for acute appendicitis. Among the various steps of the procedure one of the rate limiting step is the ligation of the appendicular stump which can be done using suture material, metallic clips and hem o loks. This study compares the effect the using metallic clips versus suture material in the ligation of appendicular stump in terms of length of surgery and associated intra-operative complications. The patients included will be within the age group of 15-60 years, with BMI of 18-28kg/m2, and with acute appendicitis of upto grade 3. The data will be analyzed using SPSS a p value of <0.05 will be considered as statistically significant.
- Conditions
- Laparoscopic Appendectomy
- Being tested
- Metallic clip ligation of the appendicular stump, Suture ligation of appendicular stump
- Keywords
- Appendicitis, Laparoscopy
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metallic clip ligation of the appendicular stumpDevice
The group A patients will be having the appendicular stump ligated using the metallic clip, and assessed in terms of length of surgery and associated intra operative complications.
Suture ligation of appendicular stumpDevice
The appendicular stump in the second arm will be ligated using appropriate suture material and assessed in terms of length of surgery and rate of intraoperative complications.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Patients undergoing metallic clip ligation | Active comparator | One of the standard methods of appendicular stump ligation Receives: Device: Metallic clip ligation of the appendicular stump |
| Group B - Patients undergoing suture material ligation of appendicular stump | Experimental | A feasible testing method with an anticipated increase in the length of surgery Receives: Device: Suture ligation of appendicular stump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of surgery
The length of surgery will be measured in terms of minutes from the start of the pneumoperitoneum insufflation till the evacuation of the pneumoperitoneum at the conclusion of the surgery.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion15 Feb 2026 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic AppendectomyStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinnah Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MUHAMMAD SAUD IQBAL, Jinnah Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129746
- Sponsor's protocol ID
- Jinnah Hospital Lahore
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The individual patient data will not be shared with other researchers on the basis of keeping confidentiality of the patients since this is a small center localized study. The matter was discussed with the ethical review board and the study was agreed upon under the aforementioned condition.
Publications
Lee JS, Hong TH. Comparison of various methods of mesoappendix dissection in laparoscopic appendectomy. J Laparoendosc Adv Surg Tech A. 2014 Jan;24(1):28-31. doi: 10.1089/lap.2013.0374. Epub 2013 Nov 8.
PubMed 24206120Sohn M, Agha A, Bremer S, Lehmann KS, Bormann M, Hochrein A. Surgical management of acute appendicitis in adults: A review of current techniques. Int J Surg. 2017 Dec;48:232-239. doi: 10.1016/j.ijsu.2017.11.028. Epub 2017 Nov 16.
PubMed 29155250
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Metallic Clip Ligation and Suture Ligation of Appendicular Stump in Laparoscopic Appendectomy, a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07129746
- Acronym / sponsor ID
- Jinnah Hospital Lahore
- Conditions
- Laparoscopic Appendectomy
- Keywords
- Appendicitis, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Jinnah HospitalUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 19 Aug 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.
Laparoscopic appendectomy is the standard procedure for acute appendicitis. Among the various steps of the procedure one of the rate limiting step is the ligation of the appendicular stump which can be done using suture material, metallic clips and hem o loks. This study compares the effect the using metallic clips versus suture material in the ligation of appendicular stump in terms of length of surgery and associated intra-operative complications. The patients included will be within the age group of 15-60 years, with BMI of 18-28kg/m2, and with acute appendicitis of upto grade 3. The data will be analyzed using SPSS a p value of <0.05 will be considered as statistically significant.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Patients undergoing metallic clip ligation | Active comparator | Device: Metallic clip ligation of the appendicular stumpOne of the standard methods of appendicular stump ligation |
| Group B - Patients undergoing suture material ligation of appendicular stump | Experimental | Device: Suture ligation of appendicular stumpA feasible testing method with an anticipated increase in the length of surgery |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Both genders, within the age bracket of 15 years - 60 years.
- With a BMI within the range of 18 - 28 kg/m2.
- With a diagnosis made by a consultant surgeon and the grade of appendicitis upto 3.
Key exclusion criteria (3 listed)
- Patients with long standing comorbidities including chronic liver disease, diabetes mellitus, chronic kidney disease and hemorrhagic disorders.
- Patients taking anticoagulants, carrier of active cases of Hepatitis B, C and/or HIV.
- Patients on immunosuppression therapy. Diameter of appendicular stump of more than 10mm, perforated appendix, laparoscopic appendectomy converted to open appendectomy pelvic appendicitis and sub-hepatic appendicitis.
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 |
|---|---|---|
| Metallic clip ligation of the appendicular stumpThe group A patients will be having the appendicular stump ligated using the metallic clip, and assessed in terms of length of surgery and associated intra operative complications. | Device | Group A - Patients undergoing metallic clip ligation |
| Suture ligation of appendicular stumpThe appendicular stump in the second arm will be ligated using appropriate suture material and assessed in terms of length of surgery and rate of intraoperative complications. | Device | Group B - Patients undergoing suture material ligation of appendicular stump |
Primary outcome
Length of surgery
Time frame: Intraoperative
The length of surgery will be measured in terms of minutes from the start of the pneumoperitoneum insufflation till the evacuation of the pneumoperitoneum at the conclusion of the surgery.
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 19 Aug 2025.
- Background: PubMed 24206120Lee JS, Hong TH. Comparison of various methods of mesoappendix dissection in laparoscopic appendectomy. J Laparoendosc Adv Surg Tech A. 2014 Jan;24(1):28-31. doi: 10.1089/lap.2013.0374. Epub 2013 Nov 8.
- Background: PubMed 29155250Sohn M, Agha A, Bremer S, Lehmann KS, Bormann M, Hochrein A. Surgical management of acute appendicitis in adults: A review of current techniques. Int J Surg. 2017 Dec;48:232-239. doi: 10.1016/j.ijsu.2017.11.028. Epub 2017 Nov 16.
- Individual participant dataSharing planned: Undecided. The individual patient data will not be shared with other researchers on the basis of keeping confidentiality of the patients since this is a small center localized study. The matter was discussed with the ethical review board and the study was agreed upon under the aforementioned condition.
Related trials for Laparoscopic Appendectomy
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Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis
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Retrospective Acute Care Appendectomy Study
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metallic clip ligation of the appendicular stump and Suture ligation of appendicular stump in people with Laparoscopic Appendectomy, run by Jinnah Hospital at 1 site in Pakistan.
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 3 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 19 Aug 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 Pakistan. 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?
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?
Contact MUHAMMAD SAUD IQBAL, MBBS (+923029424346, saudiqbal08@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of surgery (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07129746, which also lists 2 linked publications.
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 19 Aug 2025.