Pain in Single Incision Laparoscopic Surgery Cholecystectomy

Laparoscopic Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872287
• Other study ID #: GH-1948-01
• Secondary ID: GHDS-12345-1
• Status: Completed
• Phase: Phase 4
• First received: March 30, 2009
• Last updated: March 30, 2009
• Start date: September 2008
• Est. completion date: December 2008

Study information

• Verified date: March 2009
• Source: G. Hatzikosta General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 28 Years to 75 Years

Eligibility

Inclusion Criteria:

• Body Mass Index less than 30

• Attacks of cholelithiasis

Exclusion Criteria:

• Body Mass Index more than 30

• Signs of acute cholecystitis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

Procedure:
• Laparoscopic Cholecystectomy
Four ports classic laparoscopic cholecystectomy
• SILS
Single transumbilical incision laparoscopic cholecystectomy

Locations

Country	Name	City	State
Greece	G. Hatzikosta General Hospital	Ioannina	Epirus

Sponsors (1)

Lead Sponsor	Collaborator
G. Hatzikosta General Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SILS cholecystectomy, except the invisible scar, has significantly less abdominal and shoulder pain scores			Yes