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A Randomised Comparison Between Single Incision Laparoscopic Cholecystectomy and Standard Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT01094379
Recruitment Status : Unknown
Verified June 2010 by University of Athens.
Recruitment status was:  Recruiting
First Posted : March 26, 2010
Last Update Posted : June 25, 2010
Sponsor:
Information provided by:
University of Athens

Tracking Information
First Submitted Date  ICMJE March 23, 2010
First Posted Date  ICMJE March 26, 2010
Last Update Posted Date June 25, 2010
Study Start Date  ICMJE April 2010
Estimated Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2010)
Postoperative pain [ Time Frame: 24h ]
Postoperative pain will be assessed using a visual analogue pain score
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2010)
  • operating time [ Time Frame: Duration of surgical procedure ]
  • nausea or vomiting [ Time Frame: 24 h ]
  • tissue damage [ Time Frame: 24h ]
  • pulmonary function [ Time Frame: 24h ]
  • cosmetic result [ Time Frame: 4 weeks ]
  • Quality of life questionnaire [ Time Frame: 1 week ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomised Comparison Between Single Incision Laparoscopic Cholecystectomy and Standard Laparoscopic Cholecystectomy
Official Title  ICMJE A Randomised Comparison of Postoperative Pain and Recovery Between Single Incision Laparoscopic Cholecystectomy Using One Port and Standard Laparoscopic Cholecystectomy Using Four Ports
Brief 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.

Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Cholecystectomy, Laparoscopic
Intervention  ICMJE
  • Procedure: Standard laparoscopic cholecystectomy
    Laparoscopic cholecystectomy using four entry sites to the abdominal cavity
    Other Name: Traditional laparoscopic cholecystectomy
  • Procedure: Single incision laparoscopic cholecystectomy
    Laparoscopic cholecystectomy using one entry site to the abdominal cavity
    Other Name: One port laparoscopic cholecystectomy
Study Arms  ICMJE
  • Active Comparator: Standard lap chole
    Laparoscopic cholecystectomy using four entry sites to the abdominal cavity
    Intervention: Procedure: Standard laparoscopic cholecystectomy
  • Active Comparator: Single incision lap chole
    Laparoscopic cholecystectomy using one entry site to the abdominal cavity
    Intervention: Procedure: Single incision laparoscopic cholecystectomy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 25, 2010)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2011
Estimated Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01094379
Other Study ID Numbers  ICMJE Aretaieion01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Antonios Vezakis, University of Athens
Study Sponsor  ICMJE University of Athens
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Antonios Vezakis, lecturer University of Athens
PRS Account University of Athens
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP