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
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
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