EFFECT OF USING SAME DERMATOME LİNE FOR ALL PORT SİTES IN LAPAROSCOPIC APPENDECTOMY IN ACUTE APANDICITIS (DERMATOME)
Primary Purpose
Appendicitis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
laparoscopic appendectomy port sites
Sponsored by
About this trial
This is an interventional prevention trial for Appendicitis focused on measuring dermatome, laparoscopic appendectomy
Eligibility Criteria
Inclusion Criteria:
- The patients who will undergo to Laparoscopic Appendectomy for Acute Apandisitis older than 18 years old.
Exclusion Criteria:
- Perforated apandisitis
- Plastrone apndisitis
Sites / Locations
- Fatih Sultan Mehmet Research and Training Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
classic port sites
same dermatome port sites
Arm Description
. Port sites located 1 infraumbilical , 1 right lower quadrant and 1 left lower quadrent
One of the port will put in infraumbilical site and the other ones will put 10 cm right and left side from infraumbilical port.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03792802
First Posted
January 2, 2019
Last Updated
March 19, 2021
Sponsor
Fatih Sultan Mehmet Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03792802
Brief Title
EFFECT OF USING SAME DERMATOME LİNE FOR ALL PORT SİTES IN LAPAROSCOPIC APPENDECTOMY IN ACUTE APANDICITIS
Acronym
DERMATOME
Official Title
EFFECT OF USING SAME DERMATOME LİNE FOR ALL PORT SİTES IN LAPAROSCOPIC APPENDECTOMY IN ACUTE APANDICITIS
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
January 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fatih Sultan Mehmet Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Most of surgeon use 3 port sites for the Laparoscopic appendectomy in acute apandisitis. One of them places to infraumbilical region.,The other ports place to 1 right lower quadrant and 1 left lower quadrent routinly. In this study we will define T10 dermatome lregion in 40 patients who are planing to Laparoscopic appendectomy because of acute apandisitis older than 18 years old , before the surgery . All of LA port sites will put in this region .One of the port will put in infraumbilical site and the other ones will put 10 cm right and left side from infraumbilical port. In control group classic LA port sites will be used in the surgery for 40 patients.These two groups will compare after the surgery by Visual Analog Scala (VAS) Postoperative pain quantity will save by using VAS. Measurements will save in 1 hour,2 hour , 6 hour ,12 hour and 24 hour. All patients will take the same pain relief medication peroperatively and postoperatively. If the pain score would be more than 3 in VAS , all patient will take additional analgesic doses.Patients and VAS researcher will not know the patients group .Study will do as double blind.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
Keywords
dermatome, laparoscopic appendectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Model 1: Single dermatome laparoscopic appendectomy Model 2: Standard laparoscopic appendectomy
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Care provider, participant and investigator did not know which type of surgery has applicated.
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
classic port sites
Arm Type
Active Comparator
Arm Description
. Port sites located 1 infraumbilical , 1 right lower quadrant and 1 left lower quadrent
Arm Title
same dermatome port sites
Arm Type
Active Comparator
Arm Description
One of the port will put in infraumbilical site and the other ones will put 10 cm right and left side from infraumbilical port.
Intervention Type
Procedure
Intervention Name(s)
laparoscopic appendectomy port sites
Other Intervention Name(s)
port sites in the same dermatome T10
Intervention Description
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
Primary Outcome Measure Information:
Title
compare of same dermatome trochar sites and different dermatomes trokar sites methods for postoperative pain relief by VAS (Visual Analog Scala)
Description
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.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patients who will undergo to Laparoscopic Appendectomy for Acute Apandisitis older than 18 years old.
Exclusion Criteria:
Perforated apandisitis
Plastrone apndisitis
Facility Information:
Facility Name
Fatih Sultan Mehmet Research and Training Hospital
City
Istanbul
ZIP/Postal Code
34734
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
EFFECT OF USING SAME DERMATOME LİNE FOR ALL PORT SİTES IN LAPAROSCOPIC APPENDECTOMY IN ACUTE APANDICITIS
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