Pain in Single Incision Laparoscopic Surgery Cholecystectomy

G. Hatzikosta General Hospital

Status and phase: Completed; Phase 4

Conditions: Laparoscopic Cholecystectomy

Treatments: Procedure: Laparoscopic Cholecystectomy; Procedure: SILS

Study type: Interventional

Funder types: Other

Identifiers

NCT00872287

GHDS-12345-1

GH-1948-01

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 28 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body Mass Index less than 30
• Attacks of cholelithiasis

Exclusion criteria

• Body Mass Index more than 30
• Signs of acute cholecystitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Laparoscopic Cholecystectomy

Active Comparator group

Description:

Four ports classic laparoscopic cholecystectomy

Treatment:

Procedure: Laparoscopic Cholecystectomy

SILS

Active Comparator group

Description:

Single transumbilical incision laparoscopic cholecystectomy

Treatment:

Procedure: SILS