Appendicitis (Diagnosis)OSCVLNCT07689123
Evaluating the Outcome of Surgical Clip Versus Ligatures in Securing Base of Appendix in Laparoscopic Appendicectomy.
A study testing single polymeric clip (XXL Click'aV Plus, Grena) and suture ligature in people with Appendicitis (Diagnosis), run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
The goal of this clinical trial is to evaluate the outcome of using surgical clip versus ligature to secure the base of appendix during laparoscopic appendicectomy. The main questions it aims to answer are to compare the post op complications. Compare the length of hospital stay and to compare the impact of cost. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendicitis (Diagnosis)
- What is being tested?
- single polymeric clip (XXL Click'aV Plus, Grena) and suture ligature
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jul 2025to 27 Feb 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years old
- Both genders
- Planned for laparoscopic appendicectomy
Who cannot join
- Patient not consented
- Appendix perforated at base or unhealthy appendix base
- Conversion to open appendicectomy
- Diagnosed with other pathology intra-operatively
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Outcome of Surgical Clip Versus Ligatures in Securing Base of Appendix in Laparoscopic Appendicectomy. A Randomized Controlled Single Blinded Study
The goal of this clinical trial is to evaluate the outcome of using surgical clip versus ligature to secure the base of appendix during laparoscopic appendicectomy. The main questions it aims to answer are to compare the post op complications. Compare the length of hospital stay and to compare the impact of cost.
Researches will compare the use of surgical clip versus a suture ligature. Participants whom agreed to participate will be randomly assigned into group either using surgical clip or suture ligature to be used during the surgery. Vitis outpatient clinic after 1 month for follow up.
- Conditions
- Appendicitis (Diagnosis)
- Being tested
- single polymeric clip (XXL Click'aV Plus, Grena), suture ligature
- Medical subject headings
- Appendicitis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single polymeric clip (XXL Click'aV Plus, Grena)Device
single polymeric clip (XXL Click'aV Plus, Grena)
suture ligatureDevice
2 suture ligatures will be used to secure base of appendic
| Study group | Role | What they receive |
|---|---|---|
| Surgical clip | Experimental | single polymeric clip (XXL Click'aV Plus, Grena) will be used to secure the base of the appendix Receives: Device: single polymeric clip (XXL Click'aV Plus, Grena) |
| Suture ligature | Active comparator | 2 Suture ligature Laprotie (Ecosorb 0 , Vigilenz) will be used to secure the base of appendix Receives: Device: suture ligature |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the post operative complications
Post operative complications monitored with the use of Clavein Dindo classification
Measured: up to 1 month post op
Secondary outcomes (2)
Length of stay
Length of hospital stay post operative
Measured: 1 month
Cost
to compare impact of cost
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Jul 2025
- Primary completion10 Feb 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Appendicitis (Diagnosis)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, THEOANN LYCIA DANIEL, Universiti Sains Malaysia
- Investigators
- THEOANN LYCIA DANIEL, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689123
- Sponsor's protocol ID
- USM/JEPeM/KK/25010103
- Other IDs
- RSCH ID-24-06580-CZW
- Acronym
- OSCVL
- Status last verified
- Jul 2026
- First submitted
- 20 Mar 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In order to protect patient privacy
Publications
Colak E, Kement M, Ozlem N, Mutlu T, Yildirim K, Gurer A, Aktimur R. A comparison of nonabsorbable polymeric clips and endoloop ligatures for the closure of the appendicular stump in laparoscopic appendectomy: a prospective, randomized study. Surg Laparosc Endosc Percutan Tech. 2013 Jun;23(3):255-8. doi: 10.1097/SLE.0b013e31828b8382.
PubMed 23751988Delibegovic S, Mehmedovic Z. The influence of the different forms of appendix base closure on patient outcome in laparoscopic appendectomy: a randomized trial. Surg Endosc. 2018 May;32(5):2295-2299. doi: 10.1007/s00464-017-5924-z. Epub 2017 Nov 2.
PubMed 29098432Tan TM, Okada M. The efficiency of absorbable clips in minimally invasive surgery. Surg Today. 1999;29(8):828-31. doi: 10.1007/BF02482340.
PubMed 10483770Delibegovic S, Iljazovic E, Katica M, Koluh A. Tissue reaction to absorbable endoloop, nonabsorbable titanium staples, and polymer Hem-o-lok clip after laparoscopic appendectomy. JSLS. 2011 Jan-Mar;15(1):70-6. doi: 10.4293/108680811X13022985131336.
PubMed 21902947Delibegovic S, Matovic E. Hem-o-lok plastic clips in securing of the base of the appendix during laparoscopic appendectomy. Surg Endosc. 2009 Dec;23(12):2851-4. doi: 10.1007/s00464-009-0493-4. Epub 2009 May 14.
PubMed 19440790Delibegovic S. The use of a single Hem-o-lok clip in securing the base of the appendix during laparoscopic appendectomy. J Laparoendosc Adv Surg Tech A. 2012 Jan-Feb;22(1):85-7. doi: 10.1089/lap.2011.0348. Epub 2011 Dec 6.
PubMed 22145605Arcovedo R, Barrera H, Reyes HS. Securing the appendiceal stump with the Gea extracorporeal sliding knot during laparoscopic appendectomy is safe and economical. Surg Endosc. 2007 Oct;21(10):1764-7. doi: 10.1007/s00464-007-9239-3. Epub 2007 Mar 13.
PubMed 17353987Kazemier G, in't Hof KH, Saad S, Bonjer HJ, Sauerland S. Securing the appendiceal stump in laparoscopic appendectomy: evidence for routine stapling? Surg Endosc. 2006 Sep;20(9):1473-6. doi: 10.1007/s00464-005-0525-7. Epub 2006 Jul 3.
PubMed 16823654Hanssen A, Plotnikov S, Dubois R. Laparoscopic appendectomy using a polymeric clip to close the appendicular stump. JSLS. 2007 Jan-Mar;11(1):59-62.
PubMed 17651557Hue CS, Kim JS, Kim KH, Nam SH, Kim KW. The usefulness and safety of Hem-o-lok clips for the closure of appendicular stump during laparoscopic appendectomy. J Korean Surg Soc. 2013 Jan;84(1):27-32. doi: 10.4174/jkss.2013.84.1.27. Epub 2012 Dec 26.
PubMed 23323232Hardin DM Jr. Acute appendicitis: review and update. Am Fam Physician. 1999 Nov 1;60(7):2027-34.
PubMed 10569505Partecke LI, Kessler W, von Bernstorff W, Diedrich S, Heidecke CD, Patrzyk M. Laparoscopic appendectomy using a single polymeric clip to close the appendicular stump. Langenbecks Arch Surg. 2010 Nov;395(8):1077-82. doi: 10.1007/s00423-010-0671-9. Epub 2010 Jun 26.
PubMed 20577759Poon SHT, Law SY, Lai ATY. Clips closure versus endoloop ligation in laparoscopic appendectomy: a systematic review and meta-analysis of comparative studies. Ann Med Surg (Lond). 2023 Sep 6;85(10):5011-5021. doi: 10.1097/MS9.0000000000001260. eCollection 2023 Oct.
PubMed 37811063
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Outcome of Surgical Clip Versus Ligatures in Securing Base of Appendix in Laparoscopic Appendicectomy. A Randomized Controlled Single Blinded Study
- ClinicalTrials.gov ID
- NCT07689123
- Acronym / sponsor ID
- OSCVL / USM/JEPeM/KK/25010103
- Conditions
- Appendicitis (Diagnosis)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 8 Jul 2026 (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 goal of this clinical trial is to evaluate the outcome of using surgical clip versus ligature to secure the base of appendix during laparoscopic appendicectomy. The main questions it aims to answer are to compare the post op complications. Compare the length of hospital stay and to compare the impact of cost.
Researches will compare the use of surgical clip versus a suture ligature. Participants whom agreed to participate will be randomly assigned into group either using surgical clip or suture ligature to be used during the surgery. Vitis outpatient clinic after 1 month for follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical clip | Experimental | Device: single polymeric clip (XXL Click'aV Plus, Grena)single polymeric clip (XXL Click'aV Plus, Grena) will be used to secure the base of the appendix |
| Suture ligature | Active comparator | Device: suture ligature2 Suture ligature Laprotie (Ecosorb 0 , Vigilenz) will be used to secure the base of appendix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years old
- Both genders
- Planned for laparoscopic appendicectomy
Key exclusion criteria (5 listed)
- Patient not consented
- Appendix perforated at base or unhealthy appendix base
- Conversion to open appendicectomy
- Diagnosed with other pathology intra-operatively
- Pregnant 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 |
|---|---|---|
| single polymeric clip (XXL Click'aV Plus, Grena)single polymeric clip (XXL Click'aV Plus, Grena) | Device | Surgical clip |
| suture ligature2 suture ligatures will be used to secure base of appendic | Device | Suture ligature |
Primary outcome
To compare the post operative complications
Time frame: up to 1 month post op
Post operative complications monitored with the use of Clavein Dindo classification
2 secondary outcomes
Length of stay
Time frame: 1 month
Cost
Time frame: 1 month
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 8 Jul 2026.
- Background: PubMed 23751988Colak E, Kement M, Ozlem N, Mutlu T, Yildirim K, Gurer A, Aktimur R. A comparison of nonabsorbable polymeric clips and endoloop ligatures for the closure of the appendicular stump in laparoscopic appendectomy: a prospective, randomized study. Surg Laparosc Endosc Percutan Tech. 2013 Jun;23(3):255-8. doi: 10.1097/SLE.0b013e31828b8382.
- Background: PubMed 29098432Delibegovic S, Mehmedovic Z. The influence of the different forms of appendix base closure on patient outcome in laparoscopic appendectomy: a randomized trial. Surg Endosc. 2018 May;32(5):2295-2299. doi: 10.1007/s00464-017-5924-z. Epub 2017 Nov 2.
- Background: PubMed 10483770Tan TM, Okada M. The efficiency of absorbable clips in minimally invasive surgery. Surg Today. 1999;29(8):828-31. doi: 10.1007/BF02482340.
- Background: PubMed 21902947Delibegovic S, Iljazovic E, Katica M, Koluh A. Tissue reaction to absorbable endoloop, nonabsorbable titanium staples, and polymer Hem-o-lok clip after laparoscopic appendectomy. JSLS. 2011 Jan-Mar;15(1):70-6. doi: 10.4293/108680811X13022985131336.
- Background: PubMed 19440790Delibegovic S, Matovic E. Hem-o-lok plastic clips in securing of the base of the appendix during laparoscopic appendectomy. Surg Endosc. 2009 Dec;23(12):2851-4. doi: 10.1007/s00464-009-0493-4. Epub 2009 May 14.
- Background: PubMed 22145605Delibegovic S. The use of a single Hem-o-lok clip in securing the base of the appendix during laparoscopic appendectomy. J Laparoendosc Adv Surg Tech A. 2012 Jan-Feb;22(1):85-7. doi: 10.1089/lap.2011.0348. Epub 2011 Dec 6.
- Background: PubMed 17353987Arcovedo R, Barrera H, Reyes HS. Securing the appendiceal stump with the Gea extracorporeal sliding knot during laparoscopic appendectomy is safe and economical. Surg Endosc. 2007 Oct;21(10):1764-7. doi: 10.1007/s00464-007-9239-3. Epub 2007 Mar 13.
- Background: PubMed 16823654Kazemier G, in't Hof KH, Saad S, Bonjer HJ, Sauerland S. Securing the appendiceal stump in laparoscopic appendectomy: evidence for routine stapling? Surg Endosc. 2006 Sep;20(9):1473-6. doi: 10.1007/s00464-005-0525-7. Epub 2006 Jul 3.
- Background: PubMed 17651557Hanssen A, Plotnikov S, Dubois R. Laparoscopic appendectomy using a polymeric clip to close the appendicular stump. JSLS. 2007 Jan-Mar;11(1):59-62.
- Background: PubMed 23323232Hue CS, Kim JS, Kim KH, Nam SH, Kim KW. The usefulness and safety of Hem-o-lok clips for the closure of appendicular stump during laparoscopic appendectomy. J Korean Surg Soc. 2013 Jan;84(1):27-32. doi: 10.4174/jkss.2013.84.1.27. Epub 2012 Dec 26.
- Background: PubMed 10569505Hardin DM Jr. Acute appendicitis: review and update. Am Fam Physician. 1999 Nov 1;60(7):2027-34.
- Background: PubMed 20577759Partecke LI, Kessler W, von Bernstorff W, Diedrich S, Heidecke CD, Patrzyk M. Laparoscopic appendectomy using a single polymeric clip to close the appendicular stump. Langenbecks Arch Surg. 2010 Nov;395(8):1077-82. doi: 10.1007/s00423-010-0671-9. Epub 2010 Jun 26.
- Individual participant dataSharing planned: No. In order to protect patient privacy
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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.
THEOANN LYCIA DANIEL principal investigator
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single polymeric clip (XXL Click'aV Plus, Grena) and suture ligature in people with Appendicitis (Diagnosis), run by Universiti Sains Malaysia at 1 site in Malaysia.
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 5 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 8 Jul 2026. 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 Malaysia. 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?
To compare the post operative complications (time frame: up to 1 month post op). 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 NCT07689123, which also lists 13 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 8 Jul 2026.