Non Absorbable Clips vs Endoloops in Laproscopic Appendicectomy

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

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.

Study Overview

• Status: Unknown
• Conditions: Appendicitis
• Intervention / Treatment: Other: endoloops; Device: polymeric non absorbable clips

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mohamed ashraf, master; Phone Number: 01060624371; Email: akhel93@yahoo.com
• Study Contact Backup: Name: Morssy mohamed, professor; Phone Number: 01006234545; Email: morssy.mohamed@med.au.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: endoloop ligation; securing appendicular base with endoloops	Other: endoloops; a method to secure appendicular stump
ACTIVE_COMPARATOR: non absorbable polymeric clips; securing appendicular base with non absorbable polymeric clips	Device: polymeric non absorbable clips; a method to secure appendicular stump

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Is there difference in the overall operating time between the two cohorts	intraoperative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Hesham Ali, professor, Assiut university faculty of medicine

Publications and helpful links

General Publications

• 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 Sep;404(6):711-716. doi: 10.1007/s00423-019-01814-w. Epub 2019 Aug 24.
• 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.
• 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(11):CD006437. doi: 10.1002/14651858.CD006437.pub3.
• 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.
• Pogorelic Z, Kostovski B, Jeroncic A, Susnjar 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2019
• Primary Completion (ANTICIPATED): March 30, 2022
• Study Completion (ANTICIPATED): June 30, 2022

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (ACTUAL): September 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis
• Other Study ID Numbers: laparoscpic appendicectomy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes