NCT03224364

Brief Summary

To determine the safety and feasibility of solo laparoscopic appendectomy, which is defined as the application of solo surgery to laparoscopic appendectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

5 months

First QC Date

July 18, 2017

Last Update Submit

July 18, 2017

Conditions

AppendicitisLaparoscopic

Keywords

Solo surgeryCamera holderLaparoscopic Appendectomy

Outcome Measures

Primary Outcomes (1)

  • Operation time

    Operation time correlates with surgical difficulity.

    day 1

Secondary Outcomes (1)

  • Pain score

    day 3

Study Arms (2)

LC & nonsolo approach

PLACEBO COMPARATOR

The surgical intervention is nonsolo LC

Procedure: nonsolo LA

LC & solo approach

ACTIVE COMPARATOR

The surgical intervention is solo LC.

Procedure: solo LA

Interventions

nonsolo LAPROCEDURE

This patient is scheduled to undergo nonsolo laparoscpic appendectomy.

Also known as: Nonsolo laparoscopic appendectomy
LC & nonsolo approach
solo LAPROCEDURE

This patient is scheduled to undergo solo laparoscpic appendectomy.

Also known as: Solo laparoscopic appendectomy
LC & solo approach

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The patients planned to undergo elective laparoscopic appendectomy
  • Benign gallbladder diseases requiring surgery
  • The patients who are indicated for single-port laparoscopic appendectomy.

You may not qualify if:

  • the patients with complicated cholecystitis
  • the patients with the gallbladder with a thickness more than 4mm.
  • the patients who are expected to have severe peritoneal adhesion.
  • the patients with malignant gallbladder diseases.
  • the patients whose operation appears to need human assistant(s)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Say-June Kim, M.D., Ph.D.

    Daejeon St. Mary's hospital, the Catholic University of Korea, 222, Banpo-dong, Seocho-gu, Seoul, 06591, South Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Say-June Kim

CONTACT

+821087737616sayjunekim@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 18, 2017

First Posted

July 21, 2017

Study Start

August 1, 2017

Primary Completion

December 31, 2017

Study Completion

March 31, 2018

Last Updated

July 21, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share