NCT03792802

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 3, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

1.3 years

First QC Date

January 2, 2019

Last Update Submit

March 19, 2021

Conditions

Keywords

dermatomelaparoscopic appendectomy

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

Procedure: laparoscopic appendectomy port sites

same dermatome port sites

ACTIVE COMPARATOR

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

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

Also known as: port sites in the same dermatome T10
classic port sitessame dermatome port sites

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

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
Model Details: Model 1: Single dermatome laparoscopic appendectomy Model 2: Standard laparoscopic appendectomy
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

Locations