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Pain in Single Incision Laparoscopic Surgery Cholecystectomy

This study has been completed.
Information provided by:
G. Hatzikosta General Hospital Identifier:
First received: March 30, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
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 Blind (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


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

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
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Please refer to this study by its identifier: NCT00872287

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Evangelos C. Tsimoyiannis/G. Hatzikosta General Hospital, Ioannina, Greece, G. Hatzikosta General Hospital, Ioannina, Greece Identifier: NCT00872287     History of Changes
Other Study ID Numbers: GH-1948-01
Study First Received: March 30, 2009
Last Updated: March 30, 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 processed this record on May 22, 2017