Polymer Clips Vs Endoloop for Appendicular Stump Ligation
To Compare the Outcome of Polymer Clips and Endoloop Ligatures for the Closure of Appendicular Stump on the Cost of Operation and Intra-operative Time in Laparoscopic Appendectomy
1 other identifier
interventional
50
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedFirst Submitted
Initial submission to the registry
July 8, 2018
CompletedFirst Posted
Study publicly available on registry
July 19, 2018
CompletedJuly 19, 2018
July 1, 2018
1.6 years
July 8, 2018
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
EXPERIMENTALpolymer clips will be used to ligate the appendicular stump. and time and ease of appliction and cost of clips will be calculated
endoloop
ACTIVE COMPARATORendoloops will be used to ligate the appendicular stump an time and ease of application and cost of loops will be calculated
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
endoloop will be used to ligate the stump of appendix during appendectomy and time for application and cost of clips will be calculated
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Prof.Mahmood Ayyaz, MBBS,FACS
Services Hospital, Lahore
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