EFFECT OF USING SAME DERMATOME LİNE FOR ALL PORT SİTES IN LAPAROSCOPIC APPENDECTOMY IN ACUTE APANDICITIS (DERMATOME)

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.

Study Overview

• Status: Completed
• Conditions: Appendicitis
• Intervention / Treatment: Procedure: laparoscopic appendectomy port sites

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34734
    • Fatih Sultan Mehmet Research and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: classic port sites; . Port sites located 1 infraumbilical , 1 right lower quadrant and 1 left lower quadrent	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; Other Names: port sites in the same dermatome T10
ACTIVE_COMPARATOR: 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.	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; Other Names: port sites in the same dermatome T10

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fatih Sultan Mehmet Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ACTUAL): July 1, 2020
• Study Completion (ACTUAL): January 1, 2021

Study Registration Dates

• First Submitted: January 2, 2019
• First Submitted That Met QC Criteria: January 2, 2019
• First Posted (ACTUAL): January 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: dermatome; laparoscopic appendectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis
• Other Study ID Numbers: ANIL ERGIN..

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No