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| ID | Type | Description | Link |
|---|---|---|---|
| RSCH ID-24-06580-CZW | Other Identifier | MEDICAL RESEARCH & ETHICS COMMITTEE, MINISTRY OF HEALTH MALAYSIA |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical clip | Experimental | single polymeric clip (XXL Click'aV Plus, Grena) will be used to secure the base of the appendix |
|
| Suture ligature | Active Comparator | 2 Suture ligature Laprotie (Ecosorb 0 , Vigilenz) will be used to secure the base of appendix |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| single polymeric clip (XXL Click'aV Plus, Grena) | Device | single polymeric clip (XXL Click'aV Plus, Grena) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the post operative complications | Post operative complications monitored with the use of Clavein Dindo classification | up to 1 month post op |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | Length of hospital stay post operative | 1 month |
| Cost | to compare impact of cost | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| THEOANN LYCIA DANIEL | Universiti Sains Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Seberang Jaya | Seberang Jaya | Pulau Pinang | 13700 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23751988 | Background | 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. | |
| 29098432 |
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In order to protect patient privacy
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 16, 2025 | Mar 20, 2026 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| D004194 | Disease |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| suture ligature | Device | 2 suture ligatures will be used to secure base of appendic |
|
| 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. |
| 10483770 | Background | Tan TM, Okada M. The efficiency of absorbable clips in minimally invasive surgery. Surg Today. 1999;29(8):828-31. doi: 10.1007/BF02482340. |
| 21902947 | Background | 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. |
| 19440790 | Background | 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. |
| 22145605 | Background | 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. |
| 17353987 | Background | 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. |
| 16823654 | Background | 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. |
| 17651557 | Background | 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. |
| 23323232 | Background | 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. |
| 10569505 | Background | Hardin DM Jr. Acute appendicitis: review and update. Am Fam Physician. 1999 Nov 1;60(7):2027-34. |
| 20577759 | Background | 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. |
| 37811063 | Background | 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. |
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |