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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00872287
Other study ID # GH-1948-01
Secondary ID GHDS-12345-1
Status Completed
Phase Phase 4
First received March 30, 2009
Last updated March 30, 2009
Start date September 2008
Est. completion date December 2008

Study information

Verified date March 2009
Source G. Hatzikosta General Hospital
Contact n/a
Is FDA regulated No
Health authority Greece: Ethics Committee
Study type Interventional

Clinical Trial Summary

The attempt to further reduce the operative trauma in laparoscopic cholecystectomy led in new techniques, as Natural Orifice Transluminal Endoscopic Surgery (NOTES) and Single Incision Laparoscopic Surgery (SILS). These new techniques are considered as painless procedures, but there are not any publications to study a possible different pain score in new techniques versus classic laparoscopic cholecystectomy. In this randomized controlled study the researchers have investigated the pain scores, the incidence of nausea and vomiting and analgesics request after the procedure.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 28 Years to 75 Years
Eligibility Inclusion Criteria:

- Body Mass Index less than 30

- Attacks of cholelithiasis

Exclusion Criteria:

- Body Mass Index more than 30

- Signs of acute cholecystitis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Laparoscopic Cholecystectomy
Four ports classic laparoscopic cholecystectomy
SILS
Single transumbilical incision laparoscopic cholecystectomy

Locations

Country Name City State
Greece G. Hatzikosta General Hospital Ioannina Epirus

Sponsors (1)

Lead Sponsor Collaborator
G. Hatzikosta General Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary SILS cholecystectomy, except the invisible scar, has significantly less abdominal and shoulder pain scores Yes
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