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

NCT ID: NCT03792802

Last Updated: 2021-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-01-01

Brief Summary

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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

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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.

Conditions

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Appendicitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Model 1: Single dermatome laparoscopic appendectomy Model 2: Standard laparoscopic appendectomy
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Care provider, participant and investigator did not know which type of surgery has applicated.

Study Groups

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classic port sites

. Port sites located 1 infraumbilical , 1 right lower quadrant and 1 left lower quadrent

Group Type ACTIVE_COMPARATOR

laparoscopic appendectomy port sites

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

laparoscopic appendectomy port sites

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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port sites in the same dermatome T10

Eligibility Criteria

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Inclusion Criteria

* The patients who will undergo to Laparoscopic Appendectomy for Acute Apandisitis older than 18 years old.

Exclusion Criteria

* Perforated apandisitis
* Plastrone apndisitis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fatih Sultan Mehmet Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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ANIL ERGIN

asistant doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fatih Sultan Mehmet Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ANIL ERGIN..

Identifier Type: -

Identifier Source: org_study_id

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