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

Sponsor
Mansoura University (Other)
Overall Status
Completed
CT.gov ID
NCT01412996
Collaborator
(none)
250
Enrollment
1
Location
2
Arms
26
Duration (Months)
9.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aimed to compare the short term outcomes between SALC and conventional laparoscopic cholecystectomy (CLC).

Condition or Disease Intervention/Treatment Phase
  • Procedure: surgery
  • Other: SURGERY
 N/A

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

Study Type:
Interventional
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 :
Nov 1, 2009
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Jan 1, 2012

Arms and Interventions

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

    Primary Outcome Measures

    1. QUALITY OF LIFE [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 [2 hours]

      (defined as the interval between the initial skin incision and skin closure)

    2. postoperative pain [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) [10 days]

      patients were contacted by phone every day until they are able to return to their normal daily works

    4. COSMOSIS OUTCOMES [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 [POSTOPERATIVE PERIOD]

      NOMBERS OF ANALGESIC TABLETS AND NO. OF DAYS ANALGESIA NEEDED

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • GALL BLADDER STONES
    Exclusion Criteria:

    • ACUTE CHOLECYSTITIS

    • PREVIOUS LAPAROTOMY

    • ASA ABOVE 3

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mohamed Abdellatif Mansoura Egypt 35516

    Sponsors and Collaborators

    • Mansoura University

    Investigators

    • Study Chair: RAMADAN ELLITHY, MD, Mansoura University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MOHAMED ABDELLATIF, ASS. PROF., Mansoura University
    ClinicalTrials.gov Identifier:
    NCT01412996
    Other Study ID Numbers:
    • Single access chOLECYSTECTOMY
    First Posted:
    Aug 9, 2011
    Last Update Posted:
    Feb 27, 2012
    Last Verified:
    Feb 1, 2012

    Study Results

    No Results Posted as of Feb 27, 2012