Which Trocar Access Site Should We Use in Laparoscopic Ap... | NCT05311995

Studies
Which Trocar Access Site Should We Use in Laparoscopic Appendectomy?

NCT05311995

Sponsor

Inonu University

Status

Completed

Last Update Posted

Apr 5, 2022Actual

Enrollment

140Actual

Phase

Not Applicable

Conditions

Pain

Interventions

Only different trocar sites

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2021Actual

Primary Completion Date

Dec 30, 2021Actual

Completion Date

Feb 20, 2022Actual

First Submitted Date

Mar 14, 2022

First Submission Date that Met QC Criteria

Mar 28, 2022

First Posted Date

Apr 5, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2022

Last Update Posted Date

Apr 5, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Open appendectomy has been used in the treatment of appendicitis, which is among the most common emergency pathologies worldwide, since the end of the 19th century. In the 20th century, laparoscopic appendectomy came to the fore and the frequency of use increased gradually. Despite the frequency of laparoscopic appendectomy, there is no consensus on the best way to perform each procedural step. One of these steps is the trocar entry areas. In this study, investigator's aim is to compare the trocar entry areas, which are various reports in the literature, and to find the localization with the optimal usage area. 140 patients who underwent laparoscopic appendectomy between 2021-2022 were randomized into four groups and included in the study. Demographic data, peroperative findings, complications, length of stay and post-operative VAS values of the patients were evaluated.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Active Comparator	trocar entry areas:Periumblical, left lower quadrant, suprapubic	Procedure: Only different trocar sites
Group 2	Active Comparator	trocar entry areas: Periumblical, left lower quadrant, right lower quadrant	Procedure: Only different trocar sites
group 3	Active Comparator	trocar entry areas: Periumblical, right lower quadrant, suprapubic	Procedure: Only different trocar sites
Group 4	Active Comparator	trocar entry areas: Periumblical, left lower quadrant, left upper quadrant	Procedure: Only different trocar sites

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Only different trocar sites	Procedure	Only different trocar sites in literature	Group 1 Group 2 Group 4 group 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain Intensity measure	self reported pain intensity morning. item is scored 0-10 ( 0: no pain- 10: pain as bad as	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who underwent laparoscopic appendectomy

Exclusion Criteria:

patients who underwent open surgery and did not want to be involved in the study process

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ersin Gundogan		Kayseri	Kocasinan	38090	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D001064	Appendicitis

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D059413	Intraabdominal Infections

Browse Leaves

Not provided

Browse Branches

Not provided