EFFECT OF USING SAME DERMATOME LİNE FOR ALL PORT SİTES IN LAPAROSCOPIC APPENDECTOMY IN ACUTE APANDICITIS
DERMATOME
1 other identifier
interventional
60
1 country
1
Brief Summary
Acute apandicitis is the one of most common cause of abdominal pain.Most of center still use open appendectomy(OA) technic for acute apandisitis.But Semm was defined Laparoskopic appendectomy(LA) with 3 ports in 1983.Today surgeons skill and experience ara increasing about LA day by day. Because of advantages of LA , this technical tend to be gold standart in acute apandisitis. In LA , all of centers use same technic as 3 ports for the surgery. Port sites located 1 infraumbilical , 1 right lower quadrant and 1 left lower quadrent in this surgery. But 3 dermatome lines have been effected in this style of location .This 3 points causes more pain postoperatively.In our study we will define the port locations into the same dermatome line (T10) . Purpose of this research is incerasing the postoperative pain score ,decreasing postoperative need of analgesia and develop the patient satisfy.
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 Apr 2019
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
First Submitted
Initial submission to the registry
January 2, 2019
CompletedFirst Posted
Study publicly available on registry
January 3, 2019
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedMarch 23, 2021
March 1, 2021
1.3 years
January 2, 2019
March 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
compare of same dermatome trochar sites and different dermatomes trokar sites methods for postoperative pain relief by VAS (Visual Analog Scala)
pain scores of the participants will be followed at postoperative 1,2,4,6,12,24 hour (up to 24 hours). (VAS: from 0 to 10, 0 = no pain, 10 = the worst pain) The higher score idicates the worse outcome.
24 hours
Study Arms (2)
classic port sites
ACTIVE COMPARATOR. Port sites located 1 infraumbilical , 1 right lower quadrant and 1 left lower quadrent
same dermatome port sites
ACTIVE COMPARATOROne of the port will put in infraumbilical site and the other ones will put 10 cm right and left side from infraumbilical port.
Interventions
one group will have classic port sites ;.Port sites located 1 infraumbilical , 1 right lower quadrant and 1 left lower quadrent . one group will have same dermatome port sites ; One of the port will put in infraumbilical site and the other ones will put 10 cm right and left side from infraumbilical port
Eligibility Criteria
You may qualify if:
- The patients who will undergo to Laparoscopic Appendectomy for Acute Apandisitis older than 18 years old.
You may not qualify if:
- Perforated apandisitis
- Plastrone apndisitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fatih Sultan Mehmet Research and Training Hospital
Istanbul, 34734, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Care provider, participant and investigator did not know which type of surgery has applicated.
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- asistant doctor
Study Record Dates
First Submitted
January 2, 2019
First Posted
January 3, 2019
Study Start
April 1, 2019
Primary Completion
July 1, 2020
Study Completion
January 1, 2021
Last Updated
March 23, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share