NCT03591419

Brief Summary

laparoscopic appendectomy is the gold standard procedure now a days for the treatment of appendicitis. Polymer clips are new modality used for the ligation of appendicular stump. this study aims to compare the polymer clips with endoloop for the ligation of appendicular stump.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

1.6 years

First QC Date

July 8, 2018

Last Update Submit

July 8, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • surgeons perception about ease of application of clips or endoloop

    surgeons will be asked after the operation that which they think is easy way to ligate stump polyemr clip of endoloop

    4 months

  • time of application of endoloop and polymer clip

    time will be calculated in minutes since inserting instrument in abdomen till ligation of stump of appendix

    4 months

Secondary Outcomes (1)

  • cost of clips and cost of endoloop

    4 months

Study Arms (2)

polymer clip

EXPERIMENTAL

polymer clips will be used to ligate the appendicular stump. and time and ease of appliction and cost of clips will be calculated

Device: polymer clip

endoloop

ACTIVE COMPARATOR

endoloops will be used to ligate the appendicular stump an time and ease of application and cost of loops will be calculated

Device: endoloop

Interventions

polymer clips will be used to ligate the stump of appendix during appendectomy and time for application and cost of clips will be calculated

polymer clip
endoloopDEVICE

endoloop will be used to ligate the stump of appendix during appendectomy and time for application and cost of clips will be calculated

endoloop

Eligibility Criteria

Age13 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. Patients of either gender with age ranging from 15 to 60 years. 2. Patients with MANTRELS score of 7 or above on admission.

You may not qualify if:

  • \- 1. Patients having co-morbid factors such as diabetes, chronic liver disease and ischemic heart disease on previous / past medical history.
  • \. Patients with history and clinical findings suggestive of appendicular mass. 3. Patients with known gastrointestinal malignancies. 4. Patients with history of any abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Services Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Prof.Mahmood Ayyaz, MBBS,FACS

    Services Hospital, Lahore

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post Graduate Trainee

Study Record Dates

First Submitted

July 8, 2018

First Posted

July 19, 2018

Study Start

December 1, 2016

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

July 19, 2018

Record last verified: 2018-07

Locations