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Pain in Single Incision Laparoscopic Surgery Cholecystectomy

This study has been completed.
Sponsor:
Information provided by:
G. Hatzikosta General Hospital
ClinicalTrials.gov Identifier:
NCT00872287
First received: March 30, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:

U.S. FDA Resources

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 [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   28 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 30, 2009
Last Updated: March 30, 2009
Health Authority: Greece: Ethics Committee

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

ClinicalTrials.gov processed this record on June 18, 2013