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Pain in Single Incision Laparoscopic Surgery Cholecystectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00872287
First Posted: March 31, 2009
Last Update Posted: March 31, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
G. Hatzikosta General Hospital
  Purpose
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.

Condition Intervention Phase
Laparoscopic Cholecystectomy Procedure: Laparoscopic Cholecystectomy Procedure: SILS Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study of Different Pain Scores in Single Transumbilical Incision Laparoscopic Cholecystectomy Versus Classic Laparoscopic Cholecystectomy

Further study details as provided by G. Hatzikosta General Hospital:

Primary Outcome Measures:
  • SILS cholecystectomy, except the invisible scar, has significantly less abdominal and shoulder pain scores

Enrollment: 40
Study Start Date: September 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Laparoscopic Cholecystectomy
Four ports classic laparoscopic cholecystectomy
Procedure: Laparoscopic Cholecystectomy
Four ports classic laparoscopic cholecystectomy
Active Comparator: SILS
Single transumbilical incision laparoscopic cholecystectomy
Procedure: SILS
Single transumbilical incision laparoscopic cholecystectomy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   28 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body Mass Index less than 30
  • Attacks of cholelithiasis

Exclusion Criteria:

  • Body Mass Index more than 30
  • Signs of acute cholecystitis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872287


Locations
Greece
G. Hatzikosta General Hospital
Ioannina, Epirus, Greece, 45001
Sponsors and Collaborators
G. Hatzikosta General Hospital
Investigators
Study Chair: Evangelos C. Tsimoyiannis, M.D. G. Hatzikosta General Hospital, Ioannina, Greece
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Evangelos C. Tsimoyiannis/G. Hatzikosta General Hospital, Ioannina, Greece, G. Hatzikosta General Hospital, Ioannina, Greece
ClinicalTrials.gov Identifier: NCT00872287     History of Changes
Other Study ID Numbers: GH-1948-01
GHDS-12345-1
First Submitted: March 30, 2009
First Posted: March 31, 2009
Last Update Posted: March 31, 2009
Last Verified: March 2009

Keywords provided by G. Hatzikosta General Hospital:
minimally invasive surgery
scarless cholecystectomy
new techniques in laparoscopy
invisible scar
single port access
abdominal pain
shoulder pain