Which Trocar Access Site Should We Use in Laparoscopic Appendectomy?

NCT05311995 | Completed

• 1 other identifier: 2021/267
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Laparoscopy; Minimally invasive surgery; appendicitis; colorectal

Outcome Measures

Primary Outcomes (1)

• Pain Intensity measure

  self reported pain intensity morning. item is scored 0-10 ( 0: no pain- 10: pain as bad as

  1 year

Study Arms (4)

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

Only different trocar sites PROCEDURE

Only different trocar sites in literature

Group 1; Group 2; Group 4; group 3

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who underwent laparoscopic appendectomy

You may not qualify if:

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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Ersin Gundogan

Kayseri, Kocasinan, 38090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Appendicitis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Model Details: Four trocar tecnıques groups in literature

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: April 5, 2022
• Study Start: February 1, 2021
• Primary Completion: December 30, 2021
• Study Completion: February 20, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-03

Locations

TU (1)