Non Absorbable Clips vs Endoloops in Laproscopic Appendicectomy

Appendicitis Clinical Trial

Official title:

A Comparison Between Non Absorbable Polymeric Clips and Endoloop Ligatures in Securing Appendicular Stump in Laparoscopic Appendicectomy at Assiut University Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04094480
• Other study ID #: laparoscpic appendicectomy
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: September 2019
• Source: Assiut University
• Contact: mohamed ashraf, master
• Phone: 01060624371
• Email: akhel93[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

a) Compare between Nonabsorbable Polymeric Clips and Endoloop ligatures regarding:

1. technical difficulties.

2. operation time.

3. cost effectiveness.

4. postoperative complications.

5. inpatient stay.

Description:

Laparoscopic appendectomy is gradually evolving as the 'gold standard' in the treatment of acute appendicitis, especially in the obese, elderly, and in cases where the diagnosis is uncertain . There are clear benefits with the laparoscopic approach in terms of decreased pain and faster recovery than the open approach . However, disadvantages like a higher incidence of intra-abdominal collection, longer operating time, and higher costs have been documented. These may be dependent on the technique of appendicular stump closure. Therefore, the technique for appendiceal stump closure is crucial in laparoscopic appendectomy.

Laparoscopic appendectomy was first described by Semm in 1983 and is currently preferred approach for an appendectomy for many surgeons. Numerous methods of stump closure have been used, like intracorporeal suturing of the stump endoloop application, endostapler application LigaSure customized titanium clip application, and, more recently, using nonabsorbable plastic clips . Many of these techniques are either time consuming or expensive, or not available universally.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• . Able to give informed consent for inclusion in the study

• Age of the patient : Any age

Exclusion Criteria:

• • Intraoperative decision to convert to open appendicectomy

• Primary open appendicectomy

• Unable to give informed consent for participation in the study

Related Conditions & MeSH terms

• Appendicitis

Intervention

Device:
• polymeric non absorbable clips
a method to secure appendicular stump

Other:
• endoloops
a method to secure appendicular stump

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (5)

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. — View Citation

Kliuchanok K, Keßler W, Partecke I, Walschus U, Schulze T, Heidecke CD, Patrzyk M. A comparison of non-absorbable polymeric clips and staplers for laparoscopic appendiceal stump closure: analysis of 618 adult patients. Langenbecks Arch Surg. 2019 Aug 24. doi: 10.1007/s00423-019-01814-w. [Epub ahead of print] — View Citation

Mannu GS, Sudul MK, Bettencourt-Silva JH, Cumber E, Li F, Clark AB, Loke YK. Closure methods of the appendix stump for complications during laparoscopic appendectomy. Cochrane Database Syst Rev. 2017 Nov 13;11:CD006437. doi: 10.1002/14651858.CD006437.pub3. Review. — View Citation

Pogorelic Z, Kostovski B, Jeroncic A, Šušnjar T, Mrklic I, Jukic M, Juric I. A Comparison of Endoloop Ligatures and Nonabsorbable Polymeric Clips for the Closure of the Appendicular Stump During Laparoscopic Appendectomy in Children. J Laparoendosc Adv Surg Tech A. 2017 Jun;27(6):645-650. doi: 10.1089/lap.2016.0433. Epub 2016 Dec 20. — View Citation

Wilson M, Maniam P, Ibrahim A, Makaram N, Knight SR, Patil P. Polymeric clips are a quicker and cheaper alternative to endoscopic ligatures for securing the appendiceal stump during laparoscopic appendicectomy. Ann R Coll Surg Engl. 2018 Jul;100(6):454-458. doi: 10.1308/rcsann.2018.0036. Epub 2018 Mar 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	Is there difference in the overall operating time between the two cohorts	intraoperative
Secondary	Complications	Is there a difference in the rate of intraoperative and postoperative complications	30 days
Secondary	Length of hospital stay (postoperative)	Is there a significant difference in the length of postoperative stay between the two cohorts	Up to 14 days
Secondary	Readmission to hospital	Is there a difference in the thirty day readmission rates between the two cohorts	30 days
Secondary	Time of Application	Time of application of endoloop, polymeric clip measured from introducing of instruments to cutting the base of appendix	120 min