Pain in Single Incision Laparoscopic Surgery Cholecystectomy
Randomized Controlled Study of Different Pain Scores in Single Transumbilical Incision Laparoscopic Cholecystectomy Versus Classic Laparoscopic Cholecystectomy
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2008
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 30, 2009
CompletedFirst Posted
Study publicly available on registry
March 31, 2009
CompletedMarch 31, 2009
March 1, 2009
3 months
March 30, 2009
March 30, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SILS cholecystectomy, except the invisible scar, has significantly less abdominal and shoulder pain scores
Study Arms (2)
Laparoscopic Cholecystectomy
ACTIVE COMPARATORFour ports classic laparoscopic cholecystectomy
SILS
ACTIVE COMPARATORSingle transumbilical incision laparoscopic cholecystectomy
Interventions
Four ports classic laparoscopic cholecystectomy
Eligibility Criteria
You may qualify if:
- Body Mass Index less than 30
- Attacks of cholelithiasis
You may not qualify if:
- Body Mass Index more than 30
- Signs of acute cholecystitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
G. Hatzikosta General Hospital
Ioannina, Epirus, 45001, Greece
Related Publications (1)
Tsimoyiannis EC, Tsimogiannis KE, Pappas-Gogos G, Farantos C, Benetatos N, Mavridou P, Manataki A. Different pain scores in single transumbilical incision laparoscopic cholecystectomy versus classic laparoscopic cholecystectomy: a randomized controlled trial. Surg Endosc. 2010 Aug;24(8):1842-8. doi: 10.1007/s00464-010-0887-3. Epub 2010 Feb 20.
PMID: 20174950DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Evangelos C. Tsimoyiannis, M.D.
G. Hatzikosta General Hospital, Ioannina, Greece
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 30, 2009
First Posted
March 31, 2009
Study Start
September 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
March 31, 2009
Record last verified: 2009-03