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Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy: Impact on Postoperative Pain

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01348620
Enrollment
58
Registered
2011-05-05
Start date
2011-03-31
Completion date
Unknown
Last updated
2011-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

single port cholecystectomy

Brief summary

This is a single-institution, prospective, randomized controlled trial. Subjects determined to need a cholecystectomy will be consented for surgery and study participation prior to enrollment in this study. Patients will then be randomized to receive either a single port laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.

Detailed description

The main advantages of laparoscopic surgery are reduced postoperative pain, shorter hospital stay and the cosmetic result. Although reduced, however, pain is still substantial and constitutes the main clinical problem after laparoscopic cholecystectomy, in particular for future daily planned procedures. Recently, a new technique of laparoscopic cholecystectomy has been developed, in which all instruments are inserted through the same port placed in the umbilical incision. This technique for cholecystectomy has been proved to be feasible and safe by several studies. The purpose of the study is to compare postoperative pain, operating time, cosmetic result, between one port and standard laparoscopic cholecystectomy.

Interventions

DEVICESingle port laparoscopic cholecystectomy SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa)

Single port laparoscopic cholecystectomy. SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa)

PROCEDUREFour port laparoscopic cholecystectomy surgery

Four port laparoscopic cholecystectomy surgery

Sponsors

IRCCS Sacro Cuore Don Calabria di Negrar
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Biliary cholic * Biliary dyskinesia * Gallbladder polyps * Other diagnosis at the discretion of the surgeon

Exclusion criteria

* History of Acute cholecystitis * Jaundice * Choledocolithiasis * History of Pancreatitis * Severe comorbidity * BMI \> 30

Design outcomes

Primary

MeasureTime frame
Post-operative pain scores (visual analogue pain scale from 0-10)Before surgery (baseline) and 2 hrs, 4 hrs, 6hrs, 12hrs, 24hrs and 48hrs after surgery

Secondary

MeasureTime frame
Patient-assessed cosmesis on the Visual Analogue Scale30 days after surgery

Countries

Italy

Contacts

Primary ContactGiuliano Barugola, MD
barugolagiuliano@hotmail.com00390456013111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026