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

NCT01348620 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2011-05-05

No results posted yet for this study

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.

Conditions

  • Postoperative Pain

Interventions

DEVICE

Single 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)

PROCEDURE

Four port laparoscopic cholecystectomy surgery

Four port laparoscopic cholecystectomy surgery

Sponsors & Collaborators

  • IRCCS Sacro Cuore Don Calabria di Negrar

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01348620 on ClinicalTrials.gov