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Completed

NCT Number: NCT01412996

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

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

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Key information

Conditions

Evidence of Cholecystectomy

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohamed Abdellatif

Al Mansurah, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • GALL BLADDER STONES

Exclusion criteria

  • ACUTE CHOLECYSTITIS
  • PREVIOUS LAPAROTOMY
  • ASA ABOVE 3

Treatment and study plan

Surgery

Procedure

single ACCESS laparoscopic cholecystectomy

Other names: SALC, GROUP I

SURGERY

Other

CONVENTIONAL LAPAROSCOPIC CGOLECYSTECTOMY

Other names: CLC, GROUP II

Primary outcomes

  1. 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.

Secondary outcomes

  1. operative time

    Time frame: 2 hours

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

  2. postoperative pain

    Time frame: 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)

    Time frame: 10 days

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

  4. 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)

  5. ANALGESIC REQUIRMENT

    Time frame: POSTOPERATIVE PERIOD

    NOMBERS OF ANALGESIC TABLETS AND NO. OF DAYS ANALGESIA NEEDED

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Single Access Laparoscopic Cholecystectomy

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 9, 2011
Registry last updated
Feb 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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