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Clinical Trials/NCT00872287
NCT00872287
Completed
Phase 4

Randomized Controlled Study of Different Pain Scores in Single Transumbilical Incision Laparoscopic Cholecystectomy Versus Classic Laparoscopic Cholecystectomy

G. Hatzikosta General Hospital1 site in 1 country40 target enrollmentSeptember 2008

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Laparoscopic Cholecystectomy
Sponsor
G. Hatzikosta General Hospital
Enrollment
40
Locations
1
Primary Endpoint
SILS cholecystectomy, except the invisible scar, has significantly less abdominal and shoulder pain scores
Status
Completed
Last Updated
17 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
December 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
G. Hatzikosta General Hospital

Eligibility Criteria

Inclusion Criteria

  • Body Mass Index less than 30
  • Attacks of cholelithiasis

Exclusion Criteria

  • Body Mass Index more than 30
  • Signs of acute cholecystitis

Outcomes

Primary Outcomes

SILS cholecystectomy, except the invisible scar, has significantly less abdominal and shoulder pain scores

Study Sites (1)

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