Oxidative Stress in Standard Laparoscopic vs Single Port Cholecystectomy

G. Hatzikosta General Hospital

Status and phase: Completed; Phase 4

Conditions: Single Port Laparoscopy; Standard Technique; Laparoscopy; Cholecystectomy; Uncomplicated Cholelithiasis

Treatments: Other: Single incision laparoscopic cholecystectomy; Other: Laparoscopic cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01211743

GH-1948-06

Details and patient eligibility

About

Study of Oxidative Stress Markers in order to assess whether there are differences between standard laparoscopic cholecystectomy vs single port cholecystectomy for uncomplicated cholelithiasis

Enrollment: 20 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:Uncomplicated cholelithiasis American Society of Anesthesiologists (ASA) I or II No previous operations in upper abdomen Body mass index (BMI) -

Exclusion Criteria:Cholecystitis ASA > II BMI>30 Previous operations in upper abdomen Previous operations in intestine Smokers Alcohol Drugs

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

Lap Group

Active Comparator group

Description:

Patients in this group are operated for uncomplicated cholelithiasis with standard 4 port laparoscopic cholecystectomy

Treatment:

Other: Laparoscopic cholecystectomy

Other: Single incision laparoscopic cholecystectomy

SILS group

Active Comparator group

Description:

Patients in this group are operated for uncomplicated cholelithiasis with Single Incision Laparoscopic Cholecystectomy

Treatment:

Other: Single incision laparoscopic cholecystectomy