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A Randomised Comparison Between Single Incision Laparoscopic Cholecystectomy and Standard Laparoscopic Cholecystectomy

NCT01094379 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-06-25

No results posted yet for this study

Summary

Laparoscopic cholecystectomy has been established as the treatment of choice for symptomatic gallstone disease. The main advantages of laparoscopic surgery are the cosmetic result, reduced postoperative pain, shorter hospital stay and rapid return to normal activity. Although reduced, however, pain is still substantial and constitutes the main clinical problem after laparoscopic cholecystectomy, especially for planned day case procedures.

Recently, a new technique of laparoscopic cholecystectomy has been developed, in which all instruments are inserted through the same umbilical incision. The single incision laparoscopic surgery (SILS) technique for cholecystectomy has been proved to be feasible and safe by several studies.

The purpose of the study is to compare postoperative pain and operating time, nausea, vomiting, tissue damage, pulmonary function, cosmetic result, quality of life between SILS and standard laparoscopic cholecystectomy.

Conditions

  • Cholecystectomy, Laparoscopic

Interventions

PROCEDURE

Standard laparoscopic cholecystectomy

Laparoscopic cholecystectomy using four entry sites to the abdominal cavity

PROCEDURE

Single incision laparoscopic cholecystectomy

Laparoscopic cholecystectomy using one entry site to the abdominal cavity

Sponsors & Collaborators

  • University of Athens

    lead OTHER

Principal Investigators

  • Antonios Vezakis, lecturer · University of Athens

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • Greece

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 NCT01094379 on ClinicalTrials.gov