NCT01412996

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 9, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 27, 2012

Status Verified

February 1, 2012

Enrollment Period

2.2 years

First QC Date

August 4, 2011

Last Update Submit

February 24, 2012

Conditions

Evidence of Cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • QUALITY OF LIFE

    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.

    PREOPERATIVEELY, after 1 WEEK, 1 and 6 months postoperative

Secondary Outcomes (5)

  • operative time

    2 hours

  • postoperative pain

    5 days

  • days to return to normal activity (RTNA)

    10 days

  • COSMOSIS OUTCOMES

    1 AND 6 MONTHS

  • ANALGESIC REQUIRMENT

    POSTOPERATIVE PERIOD

Study Arms (2)

single ACCESS cholecystectomy

ACTIVE COMPARATOR

single ACCESS laparoscopic cholecystectomy

Procedure: surgery

traditional

ACTIVE COMPARATOR

conventional laparoscopic cholecystectomy

Other: SURGERY

Interventions

SURGERYPROCEDURE

single ACCESS laparoscopic cholecystectomy

Also known as: SALC, GROUP I
single ACCESS cholecystectomy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • GALL BLADDER STONES

You may not qualify if:

  • ACUTE CHOLECYSTITIS
  • PREVIOUS LAPAROTOMY
  • ASA ABOVE 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Abdellatif

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

  • RAMADAN ELLITHY, MD

    Mansoura University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASS. PROF.

Study Record Dates

First Submitted

August 4, 2011

First Posted

August 9, 2011

Study Start

November 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

February 27, 2012

Record last verified: 2012-02

Locations

EG(1)