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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01094379
Other study ID # Aretaieion01
Secondary ID
Status Recruiting
Phase N/A
First received March 23, 2010
Last updated June 24, 2010
Start date April 2010
Est. completion date April 2011

Study information

Verified date June 2010
Source University of Athens
Contact Antonios Vezakis, Lecturer
Phone 00306977405605
Email avezakis@hotmail.com
Is FDA regulated No
Health authority Greece: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 15 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Standard laparoscopic cholecystectomy
Laparoscopic cholecystectomy using four entry sites to the abdominal cavity
Single incision laparoscopic cholecystectomy
Laparoscopic cholecystectomy using one entry site to the abdominal cavity

Locations

Country Name City State
Greece Academic Department of Surgery, Aretaieion Hospital Athens

Sponsors (1)

Lead Sponsor Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

References & Publications (2)

Chow A, Purkayastha S, Aziz O, Paraskeva P. Single-incision laparoscopic surgery for cholecystectomy: an evolving technique. Surg Endosc. 2010 Mar;24(3):709-14. doi: 10.1007/s00464-009-0655-4. Epub 2009 Aug 18. — View Citation

Tacchino R, Greco F, Matera D. Single-incision laparoscopic cholecystectomy: surgery without a visible scar. Surg Endosc. 2009 Apr;23(4):896-9. doi: 10.1007/s00464-008-0147-y. Epub 2008 Sep 25. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative pain Postoperative pain will be assessed using a visual analogue pain score 24h No
Secondary operating time Duration of surgical procedure No
Secondary nausea or vomiting 24 h No
Secondary tissue damage 24h No
Secondary pulmonary function 24h No
Secondary cosmetic result 4 weeks No
Secondary Quality of life questionnaire Quality-of-life will be assessed using the EuroQoL EQ-5D questionnaire preoperatively and 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. 1 week No
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