Its main objective is to evaluate the clinical outcome (including patient reported outcomes) and health economic assessment (HTA) of a new re-usable system for Single Port Laparoscopic Surgery - ENDOCONE SYSTEM developed by Prof Cuschieri by undertaking a randomised controlled prospective clinical trial (RCT) on specific operations performed (on a random allocation basis) by either the traditional multi-port laparoscopic approach or the Single Port- ENDOCONE system by Karl Storz. To this effect, 300 patients meeting the trial inclusion criteria will be randomised over a three year period to have the operation by either of the two approaches.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Multiport and single-port laparoscopic cholecystectomy in patient with symptomatic gallstone disease
Ospedale San Donato
Arezzo, AR, Italy
NOT_YET_RECRUITINGOspedale Campo di Marte
Lucca, LU, Italy
NOT_YET_RECRUITINGOspedinale di Cisanello
Pisa, PI, Italy
RECRUITINGOspedale Felice Lotti
Pontedera, PI, Italy
NOT_YET_RECRUITINGConversion rate
1 = if the intervention is converted to open surgery 0 = if the intervention is completed using standard laparoscopy or single port
Time frame: During the intervention
Morbidity
1 = if the patient has surgical complications 0 = no complications
Time frame: 30 days
Mortality
Time frame: 30 days
Postoperative course
pain, measured using 1) visual linear analogue scale and 2) analgesic administration
Time frame: 1 week
Duration of hospital stay
Date of the operation Date of hospital discharge
Time frame: 6 days
Return of bowel function
Passage of flatus and/or bowel motion
Time frame: 12, 24, 48 hours
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