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Clinical Trials/NCT04094480
NCT04094480UnknownNot Applicable

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

Assiut University0 sites40 target enrollmentStarted: October 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
40
Primary Endpoint
Operative time

Study Overview

Brief 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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

endoloop ligation

Active Comparator

securing appendicular base with endoloops

Intervention: endoloops (Other)

non absorbable polymeric clips

Active Comparator

securing appendicular base with non absorbable polymeric clips

Intervention: polymeric non absorbable clips (Device)

Outcomes

Primary Outcomes

Operative time

Time Frame: intraoperative

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

Secondary Outcomes

  • Length of hospital stay (postoperative)(Up to 14 days)
  • Complications(30 days)
  • Time of Application(120 min)
  • Readmission to hospital(30 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohamed ashraf mohamed badr bestawy

resident doctor

Assiut University

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