NCT07689123

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2026

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 8, 2026

Completed
Last Updated

July 8, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

March 20, 2026

Last Update Submit

July 4, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • To compare the post operative complications

    Post operative complications monitored with the use of Clavein Dindo classification

    up to 1 month post op

Secondary Outcomes (2)

  • Length of stay

    1 month

  • Cost

    1 month

Study Arms (2)

Surgical clip

EXPERIMENTAL

single polymeric clip (XXL Click'aV Plus, Grena) will be used to secure the base of the appendix

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

Device: suture ligature

Interventions

single polymeric clip (XXL Click'aV Plus, Grena)

Surgical clip

2 suture ligatures will be used to secure base of appendic

Suture ligature

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years old
  • Both genders
  • Planned for laparoscopic appendicectomy

You may not qualify if:

  • Patient not consented
  • Appendix perforated at base or unhealthy appendix base
  • Conversion to open appendicectomy
  • Diagnosed with other pathology intra-operatively
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Seberang Jaya

Seberang Jaya, Pulau Pinang, 13700, Malaysia

Location

Related Publications (13)

  • 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.

    PMID: 23751988BACKGROUND
  • Delibegovic 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.

    PMID: 29098432BACKGROUND
  • Tan TM, Okada M. The efficiency of absorbable clips in minimally invasive surgery. Surg Today. 1999;29(8):828-31. doi: 10.1007/BF02482340.

    PMID: 10483770BACKGROUND
  • Delibegovic 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.

    PMID: 21902947BACKGROUND
  • Delibegovic 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.

    PMID: 19440790BACKGROUND
  • Delibegovic 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.

    PMID: 22145605BACKGROUND
  • Arcovedo 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.

    PMID: 17353987BACKGROUND
  • Kazemier 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.

    PMID: 16823654BACKGROUND
  • Hanssen A, Plotnikov S, Dubois R. Laparoscopic appendectomy using a polymeric clip to close the appendicular stump. JSLS. 2007 Jan-Mar;11(1):59-62.

    PMID: 17651557BACKGROUND
  • Hue 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.

    PMID: 23323232BACKGROUND
  • Hardin DM Jr. Acute appendicitis: review and update. Am Fam Physician. 1999 Nov 1;60(7):2027-34.

    PMID: 10569505BACKGROUND
  • Partecke 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.

    PMID: 20577759BACKGROUND
  • Poon 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.

    PMID: 37811063BACKGROUND

MeSH Terms

Conditions

AppendicitisDisease

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • THEOANN LYCIA DANIEL

    Universiti Sains Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

March 20, 2026

First Posted

July 8, 2026

Study Start

July 1, 2025

Primary Completion

February 10, 2026

Study Completion

February 27, 2026

Last Updated

July 8, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

In order to protect patient privacy

Locations