Influence of the Different Ways of Appendix Stump Closure on Patient Outcome in Laparoscopic Appendectomy
1 other identifier
interventional
120
1 country
1
Brief Summary
During laparoscopic appendectomy, the base of the appendix is usually secured by an endoloop ligature or the stapler. Non-absorbable plastic hem-o-lok clip was shown as an alternative technique with which laparoscopic appendectomy was done faster and cheaper than the standard techniques. However, biocompatibility of different materials udes in securing the base of appendix is different. It was observed that stapler's clips made by titanium caused the mildest inflammatory reaction and creation of adhesions. Disadvantages of stapler's are their high price. Titanium clips made for the use in laparoscopic appendectomy are safe and effective option in securing the appendicular stump in laparoscopic appendectomy. They have potential advantages over stapler, because they have the same bio compatibility, and their price is lower.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2016
Shorter than P25 for not_applicable
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
October 2, 2016
CompletedFirst Submitted
Initial submission to the registry
October 12, 2016
CompletedFirst Posted
Study publicly available on registry
October 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2017
CompletedResults Posted
Study results publicly available
June 14, 2017
CompletedJune 14, 2017
June 1, 2017
3 months
October 12, 2016
March 6, 2017
June 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Morbidity
Overall morbidity following the securing of the base of the appendix, defined as any adverse event occurring from the time of securing the base of the appendix until the 30th day.
30 days
Secondary Outcomes (5)
Intra-perative Complications
120 min.
Postoperative Complications
30 days
Operative Time
120 min.
Time of Application
120 min
Hospital Stay
30 days
Study Arms (4)
Laparoscopic appendectomy. E group.
EXPERIMENTALThe securing the base of appendix by Endo-loop.
Laparoscopic appendectomy. S group.
EXPERIMENTALThe securing the base of appendix by stapler.
Laparoscopic appendectomy. H group.
EXPERIMENTALThe securing the base of appendix by Hem-o-lok clip.
Laparoscopic appendectomy. DS group.
EXPERIMENTALThe securing the base of appendix by DS clip.
Interventions
The securing the base of appendix by endoloop.
The securing the base of appendix by Stapler.
The securing the base of appendix by Hem-o-lok clip.
The securing the base of appendix by DS clip.
Eligibility Criteria
You may qualify if:
- Patient with accute appendicits
You may not qualify if:
- Patient younger than 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Clinical Center Tuzla
Tuzla, 75000, Bosnia and Herzegovina
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Samir Delibegovic
- Organization
- University Clinical Center Tuzla
Study Officials
- STUDY CHAIR
Enver Zerem, MD, PhD
University Clinical Center Tuzla
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- The study included 120 patients randomly divided into four groups with 30 patients in each. The study was not blinded. The nurse designated for participation in this study allocated the patients randomly into four groups by selecting a sealed opaque envelope from a box and opening it in the operating theatre. A card inside the envelope contained name of the treatment. All the envelopes were prepared in advance in a ratio of 1:4, shuffled well, and placed in the box by the same nurse.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Ph.D, Professor of surgery, Head of colorectal department
Study Record Dates
First Submitted
October 12, 2016
First Posted
October 21, 2016
Study Start
October 2, 2016
Primary Completion
December 30, 2016
Study Completion
January 30, 2017
Last Updated
June 14, 2017
Results First Posted
June 14, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share
We have no plan to share IPD.