NCT04094480

Brief Summary

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

  1. 1.technical difficulties.
  2. 2.operation time.
  3. 3.cost effectiveness.
  4. 4.postoperative complications.
  5. 5.inpatient stay.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

September 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

2.5 years

First QC Date

September 17, 2019

Last Update Submit

September 18, 2019

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (1)

  • Operative time

    Is there difference in the overall operating time between the two cohorts

    intraoperative

Secondary Outcomes (4)

  • Complications

    30 days

  • Length of hospital stay (postoperative)

    Up to 14 days

  • Readmission to hospital

    30 days

  • Time of Application

    120 min

Study Arms (2)

endoloop ligation

ACTIVE COMPARATOR

securing appendicular base with endoloops

Other: endoloops

non absorbable polymeric clips

ACTIVE COMPARATOR

securing appendicular base with non absorbable polymeric clips

Device: polymeric non absorbable clips

Interventions

polymeric non absorbable clipsDEVICE

a method to secure appendicular stump

non absorbable polymeric clips
endoloopsOTHER

a method to secure appendicular stump

endoloop ligation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age of the patient : Any age

You may not qualify if:

  • Intraoperative decision to convert to open appendicectomy
  • Primary open appendicectomy
  • Unable to give informed consent for participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 31446471BACKGROUND

  • 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.

    PMID: 29543058BACKGROUND

  • 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.

    PMID: 29190038BACKGROUND

  • 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

  • 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.

    PMID: 27996377BACKGROUND

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Hesham Ali, professor

    Assiut university faculty of medicine

    STUDY DIRECTOR

Central Study Contacts

mohamed ashraf, master

CONTACT

01060624371akhel93@yahoo.com

Morssy mohamed, professor

CONTACT

01006234545morssy.mohamed@med.au.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

September 17, 2019

First Posted

September 19, 2019

Study Start

October 1, 2019

Primary Completion

March 30, 2022

Study Completion

June 30, 2022

Last Updated

September 19, 2019

Record last verified: 2019-09