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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03792802
Other study ID # ANIL ERGIN..
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date January 1, 2021

Study information

Verified date March 2021
Source Fatih Sultan Mehmet Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 1, 2021
Est. primary completion date July 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - The patients who will undergo to Laparoscopic Appendectomy for Acute Apandisitis older than 18 years old. Exclusion Criteria: - Perforated apandisitis - Plastrone apndisitis

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
laparoscopic appendectomy port sites
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

Locations

Country Name City State
Turkey Fatih Sultan Mehmet Research and Training Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Fatih Sultan Mehmet Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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