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

Condition Intervention
Evidence of Cholecystectomy
 Procedure: surgery
Other: SURGERY

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single Access Laparoscopic Cholecystectomy

Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Enrollment: 250
Study Start Date: November 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility
Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • GALL BLADDER STONES

Exclusion Criteria:

  • ACUTE CHOLECYSTITIS
  • PREVIOUS LAPAROTOMY
  • ASA ABOVE 3
  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: NCT01412996

Locations
Egypt
Mohamed Abdellatif
Mansoura, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
Study Chair: RAMADAN ELLITHY, MD Mansoura University
  More Information

Responsible Party: MOHAMED ABDELLATIF, ASS. PROF., Mansoura University
ClinicalTrials.gov Identifier: NCT01412996     History of Changes
Other Study ID Numbers: Single access chOLECYSTECTOMY 
Study First Received: August 4, 2011
Last Updated: February 24, 2012
Health Authority: Egypt: Ministry of Health and Population

ClinicalTrials.gov processed this record on September 27, 2016