Laparoscopic Cholecystectomy Clinical Trial
Official title:
Randomized Controlled Study of Different Pain Scores in Single Transumbilical Incision Laparoscopic Cholecystectomy Versus Classic Laparoscopic Cholecystectomy
Verified date | March 2009 |
Source | G. Hatzikosta General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ethics Committee |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Greece | G. Hatzikosta General Hospital | Ioannina | Epirus |
Lead Sponsor | Collaborator |
---|---|
G. Hatzikosta General Hospital |
Greece,
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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