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

ISRCTN	ISRCTN66016408
DOI	https://doi.org/10.1186/ISRCTN66016408
Secondary identifying numbers	BSUR-D-15-00094R1

Submission date: 30/10/2015
Registration date: 18/11/2015
Last edited: 17/11/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Kee-Hwan Kim
Public

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

Study information

Study design	Retrospective case-control study
Primary study design	Observational
Secondary study design	Case-control study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	Uijeongbu St. Mary's Hospital Institutional Review Board, 22/01/2015, Study No. UC15RISI0004
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	14/10/2011
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	485
Key inclusion criteria	Patients who underwent laparoscopic cholecystectomy for acute and chronic cholecystitis at a single institution
Key exclusion criteria	1. Acute cholecystitis 2. Obese patients 3. History of previous abdominal surgery
Date of first enrolment	14/10/2011
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

Korea, South

Study participating centre

Uijeongbu St Mary's Hospital

College of Medicine
The Catholic University of Korea
Uijeongbu
480-717
Korea, South

Sponsor information

Uijeongbu St Mary's Hospital (South Korea)
Hospital/treatment centre

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

"ROR"	https://ror.org/02ezaf703

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	To be confirmed at a later date
IPD sharing plan