Condition category
Surgery
Date applied
30/10/2015
Date assigned
18/11/2015
Last edited
17/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The gallbladder is a pear-shaped pouch for storing bile, a liquid made by the liver to help digest fatty foods. Laparoscopic cholecystectomy is an operation to remove the gallbladder and is the standard treatment for benign gallbladder diseases. Laparoscopic surgery leaves several scars after the operation. Operations with fewer incisions have been attempted, including single-incision laparoscopic surgery (SILS). SILS is cosmetically acceptable but is technically difficult and demanding. Therefore, we are intended to overcome the difficulties of SILS by adding an incision for an instrument called a needlescopic grasper, which just leaves a negligible scar after the operation. The aim of this study is to evaluate the safety and feasibility of needlescopic grasper assisted SILC (nSILC) compared with conventional laparoscopic cholecystectomy (CLC).

Who can participate?
Patients undergoing laparoscopic cholecystectomy for benign gallbladder disease.

What does the study involve?
We review the medical records of patients who underwent CLC or nSILC to investigate the difference in surgical outcomes, in particular to see if there are any differences in the operation time, and pain and complications following the operation.

Where is the study run from?
Uijeongbu St. Mary's Hospital (South Korea)

When is the study starting and how long is it expected to run for?
October 2011 to December 2012

Who is funding the study?
This study performed without funding and all members of this study have no competing interests

Who is the main contact?
Prof. Kee-Hwan Kim
keehwan@catholic.ac.kr

Trial website

Contact information

Type

Public

Primary contact

Prof Kee-Hwan Kim

ORCID ID

Contact details

#271
Cheonbo-ro
Uijeongbu-shi
Gyeonggi-do
Seoul
480-717
Korea
South

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BSUR-D-15-00094R1

Study information

Scientific title

Single-center experience of needle-scopic grasper assisted single incision laparoscopic cholecystectomy for gallbladder benign disease: comparison with conventional 3-port laparoscopic cholecystectomy

Acronym

Study hypothesis

Single incision laparoscopic cholecystectomy (SILC) has some technical problems. Our group has performed needlescopic grasper assisted SILC (nSILC) to overcome these problems. In this study, we introduce our technique and evaluate the safety and feasibility of this technique comparing with the conventional laparoscopic cholecystectomy (CLC).

Ethics approval

Uijeongbu St. Mary's Hospital Institutional Review Board, 22/01/2015, Study No. UC15RISI0004

Study design

Retrospective case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Patients with a benign gallbladder disease prompting operative intervention

Intervention

The medical records of 485 patients who received nSILC and CLC were reviewed retrospectively. Surgical outcomes including operative time, hospital stay, postoperative pain and perioperative complication were compared between the two techniques.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Overall operative time

Secondary outcome measures

1. Time taken to locate the critical view of safety (CVS) during operation
2. The incidence of conversion operation
3. Postoperative pain measured using the visual analogue scale (VAS)
4. Incidences of postoperative complications

Outcomes measured at baseline (immediately after admission), operation, postoperative periods of admission (postoperative day 1 and 2, and the day of discharge), and the time when patients visited the outpatient clinic after discharge.

Overall trial start date

14/10/2011

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who underwent laparoscopic cholecystectomy for acute and chronic cholecystitis at a single institution

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

485

Participant exclusion criteria

1. Acute cholecystitis
2. Obese patients
3. History of previous abdominal surgery

Recruitment start date

14/10/2011

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Korea, South

Trial participating centre

Uijeongbu St Mary's Hospital
College of Medicine The Catholic University of Korea
Uijeongbu
480-717
Korea, South

Sponsor information

Organisation

Uijeongbu St Mary's Hospital (South Korea)

Sponsor details

The Catholic University of Korea
#271
Cheonbo-ro
Uijeongbu
480-717
Korea
South

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes