NCT02978989

Brief Summary

To determine the safety and feasibility of solo laparoscopic cholecystectomy, which is defined as the application of solo surgery to laparoscopic cholecystectomy, 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 Dec 2016

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

November 29, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

November 29, 2016

Last Update Submit

February 20, 2017

Conditions

Cholecystectomy, Laparoscopic

Keywords

Laparoscopic cholecystectomySolo surgeryCamera holderCholecystitis

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 LC

LC & solo approach

ACTIVE COMPARATOR

The surgical intervention is solo LC.

Procedure: solo LC

Interventions

nonsolo LCPROCEDURE

This patient is scheduled to undergo nonsolo laparoscpic cholecystectomy.

Also known as: Nonsolo laparoscopic cholecystectomy
LC & nonsolo approach
solo LCPROCEDURE

This patient is scheduled to undergo solo laparoscpic cholecystectomy.

Also known as: Solo laparoscopic cholecystectomy
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 planed to undergo elective laparoscopic cholecystectomy
  • Benign gallbladder diseases requiring surgery
  • The patients who are indicated for single-port laparoscopic cholecystectomy.

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

Cholecystitis

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System 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, M.D.,Ph.D.

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
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 1, 2016

Study Start

December 1, 2016

Primary Completion

July 1, 2017

Study Completion

September 1, 2017

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share