Single Incision Versus Three Port Laparoscopic Cholecystectomy
1 other identifier
interventional
2
0 countries
N/A
Brief Summary
Laparoscopic cholecystectomy (LC) became the standard treatment for symptomatic gallbladder disease. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing the invasiveness of conventional laparoscopy. The aim of this study was to compare the clinical outcome of single-incision laparoscopic cholecystectomy (SILC) with three port laparoscopic cholecystectomy (TPLC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2014
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 25, 2016
CompletedFirst Posted
Study publicly available on registry
March 1, 2017
CompletedMarch 1, 2017
February 1, 2017
2 years
November 25, 2016
February 23, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
postoperative pain, visual analogue scale (VAS)
Postoperative pain was evaluated according to a visual analogue scale (VAS) from 0 (no pain) to 10 (maximum pain) on the postoperative hour six (VAS-6H).
at 6 hours
postoperative pain, visual analogue scale (VAS)
Postoperative pain was evaluated according to a visual analogue scale (VAS) from 0 (no pain) to 10 (maximum pain) on the postoperative day one (VAS-24H).
at 24 hours
Secondary Outcomes (4)
operative duration
From introduction of first trocar to the recovery of patient, up to 10 hours
post operative opioid requirements (questioner)
24 hours
lenght of hospital stay
from recovery of anaesthesia to discharge of patient, up to 4 days
cosmetic satisfactions (aesthetic scale)
one month
Study Arms (2)
Single incision LC
ACTIVE COMPARATORSingle incision laparoscopic cholecystectomy (SILC) performed through a single infra-umbilical incision using a single port device or three ports closely placed.
Three port LC
SHAM COMPARATORThree port laparoscopic cholecystectomy (TPLC) performed through three different placed trocars
Interventions
Laparoscopic cholecystectomy with single port device
Laparoscopic cholecystectomy with three port
Eligibility Criteria
You may qualify if:
- preoperative diagnosis of symptomatic gallstones
- age from 20 to 60 years,
- American Society of Anesthesiologists (ASA) grade I, II or III,
- agreement to complete the study requirement.
You may not qualify if:
- patients with contraindication to laparoscopy,
- suspected Mirizzi syndrome,
- choledocholithiasis,
- hepatobiliary malignancy,
- previous upper abdominal surgery,
- previous mesh repair of an umbilical hernia,
- long-term anticoagulant treatment,
- pregnant female
- stone more than 2 cm in preoperative ultrasonography.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
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
- Lecturer of GIT surgery and laparoendoscopy
Study Record Dates
First Submitted
November 25, 2016
First Posted
March 1, 2017
Study Start
October 1, 2014
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
March 1, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share