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Quality of Life Measures After Single Access Vs Conventional Laparoscopic Cholecystectomy: Prospective Randomized Study.

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ClinicalTrials.gov Identifier: NCT01412996
Recruitment Status : Completed
First Posted : August 9, 2011
Last Update Posted : February 27, 2012
Sponsor:
Information provided by (Responsible Party):
MOHAMED ABDELLATIF, Mansoura University

Study Description
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Brief Summary:
This study aimed to compare the short term outcomes between SALC and conventional laparoscopic cholecystectomy (CLC).

Condition or disease Intervention/treatment Phase
Evidence of Cholecystectomy Procedure: surgery Other: SURGERY Not Applicable

Detailed Description:
In a prospective study, two hundred fifty patients with symptomatic gall bladder stone were randomized to SALC or conventional laparoscopic cholecystectomy (CLC) (125 in each group). The primary endpoint of this study was to assess the total outcomes of quality of life using EuroQoL EQ-5D questionnaire. The secondary endpoints were postoperative pain, analgesia requirement and duration, operative time, perioperative complications, estimated blood loss, hospital stay, cosmoses outcomes and number of days required to return to normal activities.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single Access Laparoscopic Cholecystectomy
Study Start Date : November 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: single ACCESS cholecystectomy
single ACCESS laparoscopic cholecystectomy
 Procedure: surgery
single ACCESS laparoscopic cholecystectomy
Other Names:
  • SALC
  • GROUP I
Active Comparator: traditional
conventional laparoscopic cholecystectomy
 Other: SURGERY
CONVENTIONAL LAPAROSCOPIC CGOLECYSTECTOMY
Other Names:
  • CLC
  • GROUP II


Outcome Measures
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Primary Outcome Measures :
  1. QUALITY OF LIFE [ Time Frame: PREOPERATIVEELY, after 1 WEEK, 1 and 6 months postoperative ]
    Quality of life was the primary endpoint of this study assessed by EuroQoL EQ-5D 9 questionnaire preoperatively, 1 week, 1 and 6 months after surgery. The EQ-5D is a validated questionnaire which consists of 2 pages: the EQ-5D descriptive system and EQ visual analogue scale (EQ VAS). The WQ-5D-descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.


Secondary Outcome Measures :
  1. operative time [ Time Frame: 2 hours ]
    (defined as the interval between the initial skin incision and skin closure)

  2. postoperative pain [ Time Frame: 5 days ]
    using verbal analogue scale (VAS) from 0 to 10 (0 = no pain, 10 = severe pain)

  3. days to return to normal activity (RTNA) [ Time Frame: 10 days ]
    patients were contacted by phone every day until they are able to return to their normal daily works

  4. COSMOSIS OUTCOMES [ Time Frame: 1 AND 6 MONTHS ]
    cosmetic outcomes 1 and 6 months after surgery using Patient and Observer Scar Assessment Scale (POSAS)(10), it comprises two distinct series of Visual Analogue Scale (VAS) instruments: one is self-assessed by the patient and one by an independent doctor, ranging from 1 (poor) to 10 (excellent)

  5. ANALGESIC REQUIRMENT [ Time Frame: POSTOPERATIVE PERIOD ]
    NOMBERS OF ANALGESIC TABLETS AND NO. OF DAYS ANALGESIA NEEDED


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • GALL BLADDER STONES

Exclusion Criteria:

  • ACUTE CHOLECYSTITIS
  • PREVIOUS LAPAROTOMY
  • ASA ABOVE 3
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412996


Locations
Egypt
Mohamed Abdellatif
Mansoura, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
Study Chair: RAMADAN ELLITHY, MD Mansoura University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: MOHAMED ABDELLATIF, ASS. PROF., Mansoura University
ClinicalTrials.gov Identifier: NCT01412996     History of Changes
Other Study ID Numbers: Single access chOLECYSTECTOMY
First Posted: August 9, 2011    Key Record Dates
Last Update Posted: February 27, 2012
Last Verified: February 2012