A Randomised Comparison Between Single Incision Laparoscopic Cholecystectomy and Standard Laparoscopic Cholecystectomy
A Randomised Comparison Between Single Incision Laparoscopic Cholecystectomy and Standard Laparoscopic Cholecystectomy
Laparoscopic cholecystectomy has been established as the treatment of choice for symptomatic
 gallstone disease. The main advantages of laparoscopic surgery are the cosmetic result,
 reduced postoperative pain, shorter hospital stay and rapid return to normal activity.
 Although reduced, however, pain is still substantial and constitutes the main clinical
 problem after laparoscopic cholecystectomy, especially for planned day case procedures.

 Recently, a new technique of laparoscopic cholecystectomy has been developed, in which all
 instruments are inserted through the same umbilical incision. The single incision
 laparoscopic surgery (SILS) technique for cholecystectomy has been proved to be feasible and
 safe by several studies.

 The purpose of the study is to compare postoperative pain and operating time, nausea,
 vomiting, tissue damage, pulmonary function, cosmetic result, quality of life between SILS
 and standard laparoscopic cholecystectomy.
Laparoscopic cholecystectomy has been established as the treatment of choice for symptomatic
 gallstone disease. The main advantages of laparoscopic surgery are the cosmetic result,
 reduced postoperative pain, shorter hospital stay and rapid return to normal activity.
 Although reduced, however, pain is still substantial and constitutes the main clinical
 problem after laparoscopic cholecystectomy, especially for planned day case procedures.

 Recently, a new technique of laparoscopic cholecystectomy has been developed, in which all
 instruments are inserted through the same umbilical incision. The single incision
 laparoscopic surgery (SILS) technique for cholecystectomy has been proved to be feasible and
 safe by several studies. However, there is not for the moment any randomized study between
 standard and SILS cholecystectomy published.

 The primary end point of the study is to compare postoperative pain and secondary end points
 operating time, nausea, vomiting, tissue damage, pulmonary function, cosmetic result and
 quality of life.

 Patients admitted for laparoscopic cholecystectomy to Aretaieion Hospital, under the care of
 four surgeons, will be entered into the study after signed consent is obtained. Randomization
 will be carried out preoperatively using blocks of random numbers. Anaesthesia will be
 standardized.

 The same waterproof dressings, at the same sites, will be applied in all patients in order to
 prevent nursing and other staff from knowing what variant of operation has been carried out.

 Postoperatively, all patients will receive and identical protocol of care. Postoperative pain
 will be assessed using a visual analogue pain score. The same analgesia will be prescribed in
 all the patients, if required. Postoperative analgesia, nausea or vomiting will be recorded.

 Pulmonary function tests will be measured, in the sitting position, using a spirometer before
 and after the operation.

 Tissue damage will be assessed by measuring CRP and Interleukin-6 (IL-6). Injury or
 inflammation of the human body results in increased concentrations of the acute-phase
 reactant proteins. CRP is very consistent in response and is, therefore, the most
 satisfactory single screening test for an acute phase reactant. IL-6 is one of the most
 important mediators of the acute phase response. It is secreted by T cells and macrophages to
 stimulate immune response to trauma.

 The cosmetic result will be assessed by the patient.

 Quality-of-life will be assessed using the EuroQoL EQ-5D questionnaire preoperatively and at
 1 week postoperatively. The EQ-5D questionnaire is a generic measure of the quality of life,
 in which health status is defined in terms of 5 dimensions: mobility, self-care, usual
 activities, pain/discomfort and anxiety/depression.

 Reevaluation of the patients will take place 1 week and 4 weeks after the operation in the
 outpatient clinic.

 If we consider that we reduce postoperative pain at 35%, then with α: 0.05 and β: 0.20 we
 need 20 patients in each arm.
Inclusion Criteria:

 -  Patients with symptomatic cholelithiasis, admitted for laparoscopic cholecystectomy

 Exclusion Criteria:

 -  Patients with acute cholecystitis

 -  Patients with extensive upper abdominal incisions

 -  Patients with body mass index >30

 -  Patients on regular analgesic medication