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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Athens.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Athens
ClinicalTrials.gov Identifier:
NCT01094379
First received: March 23, 2010
Last updated: June 24, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention
Cholecystectomy, Laparoscopic
Procedure: Standard laparoscopic cholecystectomy
Procedure: Single incision laparoscopic cholecystectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomised Comparison of Postoperative Pain and Recovery Between Single Incision Laparoscopic Cholecystectomy Using One Port and Standard Laparoscopic Cholecystectomy Using Four Ports

Resource links provided by NLM:


Further study details as provided by University of Athens:

Primary Outcome Measures:
  • Postoperative pain [ Time Frame: 24h ] [ Designated as safety issue: No ]
    Postoperative pain will be assessed using a visual analogue pain score


Secondary Outcome Measures:
  • operating time [ Time Frame: Duration of surgical procedure ] [ Designated as safety issue: No ]
  • nausea or vomiting [ Time Frame: 24 h ] [ Designated as safety issue: No ]
  • tissue damage [ Time Frame: 24h ] [ Designated as safety issue: No ]
  • pulmonary function [ Time Frame: 24h ] [ Designated as safety issue: No ]
  • cosmetic result [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Quality of life questionnaire [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: April 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard lap chole
Laparoscopic cholecystectomy using four entry sites to the abdominal cavity
Procedure: Standard laparoscopic cholecystectomy
Laparoscopic cholecystectomy using four entry sites to the abdominal cavity
Other Name: Traditional laparoscopic cholecystectomy
Active Comparator: Single incision lap chole
Laparoscopic cholecystectomy using one entry site to the abdominal cavity
Procedure: Single incision laparoscopic cholecystectomy
Laparoscopic cholecystectomy using one entry site to the abdominal cavity
Other Name: One port 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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01094379

Contacts
Contact: Antonios Vezakis, Lecturer 00306977405605 avezakis@hotmail.com
Contact: George Polymeneas, Professor 00306944738558 gpolym@med.uoa.gr

Locations
Greece
Academic Department of Surgery, Aretaieion Hospital Recruiting
Athens, Greece, 11528
Principal Investigator: Antonios Vezakis, Lecturer         
Sub-Investigator: George Polymeneas, Professor         
Sponsors and Collaborators
University of Athens
Investigators
Principal Investigator: Antonios Vezakis, lecturer University of Athens
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Antonios Vezakis, University of Athens
ClinicalTrials.gov Identifier: NCT01094379     History of Changes
Other Study ID Numbers: Aretaieion01
Study First Received: March 23, 2010
Last Updated: June 24, 2010
Health Authority: Greece: Ethics Committee

Keywords provided by University of Athens:
cholecystectomy
laparoscopic
pain
single incision

ClinicalTrials.gov processed this record on July 10, 2014