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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MOHAMED ABDELLATIF, Mansoura University
ClinicalTrials.gov Identifier:
NCT01412996
First received: August 4, 2011
Last updated: February 24, 2012
Last verified: February 2012
History of Changes

August 4, 2011
February 24, 2012
November 2009
January 2012   (final data collection date for primary outcome measure)
QUALITY OF LIFE [ Time Frame: PREOPERATIVEELY, after 1 WEEK, 1 and 6 months postoperative ] [ Designated as safety issue: Yes ]
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.
cosmetic outcome [ Time Frame: after 1 and 6 months postoperative ] [ Designated as safety issue: Yes ]
1 and 6 months after surgery using Patient and Observer Scar Assessment Scale (POSAS), 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).
Complete list of historical versions of study NCT01412996 on ClinicalTrials.gov Archive Site
  • operative time [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
    (defined as the interval between the initial skin incision and skin closure)
  • postoperative pain [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    using verbal analogue scale (VAS) from 0 to 10 (0 = no pain, 10 = severe pain)
  • days to return to normal activity (RTNA) [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
    patients were contacted by phone every day until they are able to return to their normal daily works
  • COSMOSIS OUTCOMES [ Time Frame: 1 AND 6 MONTHS ] [ Designated as safety issue: Yes ]
    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)
  • ANALGESIC REQUIRMENT [ Time Frame: POSTOPERATIVE PERIOD ] [ Designated as safety issue: Yes ]
    NOMBERS OF ANALGESIC TABLETS AND NO. OF DAYS ANALGESIA NEEDED
  • operative time [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
    (defined as the interval between the initial skin incision and skin closure)
  • postoperative pain [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    using verbal analogue scale (VAS) from 0 to 10 (0 = no pain, 10 = severe pain)
  • days to return to normal activity (RTNA) [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
    patients were contacted by phone every day until they are able to return to their normal daily works
Not Provided
Not Provided
 
Quality of Life Measures After Single Access Vs Conventional Laparoscopic Cholecystectomy: Prospective Randomized Study.
Single Access Laparoscopic Cholecystectomy

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

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Evidence of Cholecystectomy
  • Procedure: surgery
    single ACCESS laparoscopic cholecystectomy
    Other Names:
    • SALC
    • GROUP I
  • Other: SURGERY
    CONVENTIONAL LAPAROSCOPIC CGOLECYSTECTOMY
    Other Names:
    • CLC
    • GROUP II
  • Active Comparator: single ACCESS cholecystectomy
    single ACCESS laparoscopic cholecystectomy
    Intervention: Procedure: surgery
  • Active Comparator: traditional
    conventional laparoscopic cholecystectomy
    Intervention: Other: SURGERY
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • GALL BLADDER STONES

Exclusion Criteria:

  • ACUTE CHOLECYSTITIS
  • PREVIOUS LAPAROTOMY
  • ASA ABOVE 3
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT01412996
Single access chOLECYSTECTOMY
Yes
MOHAMED ABDELLATIF, Mansoura University
Mansoura University
Not Provided
Study Chair: RAMADAN ELLITHY, MD Mansoura University
Mansoura University
February 2012

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