Non Absorbable Clips vs Endoloops in Laproscopic Appendicectomy

NCT ID: NCT04094480

Last Updated: 2019-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Appendicitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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endoloop ligation

securing appendicular base with endoloops

Group Type ACTIVE_COMPARATOR

endoloops

Intervention Type OTHER

a method to secure appendicular stump

non absorbable polymeric clips

securing appendicular base with non absorbable polymeric clips

Group Type ACTIVE_COMPARATOR

polymeric non absorbable clips

Intervention Type DEVICE

a method to secure appendicular stump

Interventions

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polymeric non absorbable clips

a method to secure appendicular stump

Intervention Type DEVICE

endoloops

a method to secure appendicular stump

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed ashraf mohamed badr bestawy

resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hesham Ali, professor

Role: STUDY_DIRECTOR

Assiut university faculty of medicine

Central Contacts

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mohamed ashraf, master

Role: CONTACT

01060624371

Morssy mohamed, professor

Role: CONTACT

01006234545

References

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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.

Reference Type BACKGROUND
PMID: 31446471 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29543058 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29190038 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29098432 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27996377 (View on PubMed)

Other Identifiers

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laparoscpic appendicectomy

Identifier Type: -

Identifier Source: org_study_id

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