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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Evidence of Cholecystectomy | Procedure: surgery Other: SURGERY | Not Applicable |
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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: single ACCESS cholecystectomy
single ACCESS laparoscopic cholecystectomy
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Procedure: surgery
single ACCESS laparoscopic cholecystectomy
Other Names:
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Active Comparator: traditional
conventional laparoscopic cholecystectomy
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Other: SURGERY
CONVENTIONAL LAPAROSCOPIC CGOLECYSTECTOMY
Other Names:
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- 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.
- operative time [ Time Frame: 2 hours ](defined as the interval between the initial skin incision and skin closure)
- postoperative pain [ Time Frame: 5 days ]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 ]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 ]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 ]NOMBERS OF ANALGESIC TABLETS AND NO. OF DAYS ANALGESIA NEEDED

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- GALL BLADDER STONES
Exclusion Criteria:
- ACUTE CHOLECYSTITIS
- PREVIOUS LAPAROTOMY
- ASA ABOVE 3

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
Egypt | |
Mohamed Abdellatif | |
Mansoura, Egypt, 35516 |
Study Chair: | RAMADAN ELLITHY, MD | Mansoura University |
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 |