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Post-Operative Pain After Uniportal Vats Lobectomy: Does A Smaller Incision Result In Better Recovery?

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lobectomy via UVATS
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • be aged ≥ 18 years (of either gender)
  • have provided written informed consent prior to participation in the study
  • undergoing to major lung surgery with an Uniportal VideoThoracocopic Access (UVATS).

Exclusion Criteria:

  • rethoracotomy
  • presence of pleural adhesions
  • Neuropathy
  • be a participant in another interventional clinical trial or have received another investigational device or device within the last 30 days (donation of excised tissue [lung or parts of lymph nodes] for biological research may occur in the same patients)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Smaller Incision

    Traditional Incision

    Arm Description

    UVATS access for lobectomy with small skin access 4 cm

    UVATS access for lobectomy with longer skin access 8 cm

    Outcomes

    Primary Outcome Measures

    Operative time reduction
    Operative time reduction in minutes

    Secondary Outcome Measures

    pain score
    VAS score

    Full Information

    First Posted
    July 5, 2017
    Last Updated
    July 11, 2017
    Sponsor
    University of Roma La Sapienza
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03218098
    Brief Title
    Post-Operative Pain After Uniportal Vats Lobectomy: Does A Smaller Incision Result In Better Recovery?
    Official Title
    Post-Operative Pain After Uniportal Vats Lobectomy: Does A Smaller Incision Result In Better Recovery?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    June 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Roma La Sapienza

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Post-Operative Pain After Uniportal Vats Lobectomy: Does A Smaller Incision Result In Better Recovery? Postoperative pain control remains one of the most common problems after major lung resection. Pain is considered a major independent factor responsible for increased perioperative morbidity and mortality: in particular, in patients with preoperative compromised clinical conditions. In fact, acute pain may compromise the patient's mobilization and the secretion's clearance with secondary possible bronchial obstruction and parenchymal lung infection. Today, the treatment of postoperative pain after lung resection is based on association of the pharmacological therapy, including systemic use of opioids and non-steroid drugs, epidural analgesia, intercostal nerve block and cryoanalgesia with the minimally invasive surgery, like use of mini-thoracotomy, a thoracoscopic approach or intercostal nerve protection with the use of muscle sparing. In the literature, reduced tissue damage consequent to the use of limited surgical approaches is reported to be significantly effective in decreasing early postoperative pain. Thus, the use of a minimally invasive surgery for lung resections has proved to produce more tolerable pain and allow quicker functional recovery and lower postoperative complications. The aim of this prospective randomized study was to evaluate the equivalency of a smaller incision (4 cm) when compared to a longer length (8 cm) of incision performing uniportal VATS lobectomy in terms of postoperative pain results. Primarily, to evaluate the differences of operative time between the groups. Secondly, to investigate the differences of pain scores between the two groups and the impact of pain reduction on functional results.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    44 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Smaller Incision
    Arm Type
    Experimental
    Arm Description
    UVATS access for lobectomy with small skin access 4 cm
    Arm Title
    Traditional Incision
    Arm Type
    Active Comparator
    Arm Description
    UVATS access for lobectomy with longer skin access 8 cm
    Intervention Type
    Procedure
    Intervention Name(s)
    Lobectomy via UVATS
    Intervention Description
    lobectomy with small skin access 4 cm
    Primary Outcome Measure Information:
    Title
    Operative time reduction
    Description
    Operative time reduction in minutes
    Time Frame
    up to 180 min
    Secondary Outcome Measure Information:
    Title
    pain score
    Description
    VAS score
    Time Frame
    up to 48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: be aged ≥ 18 years (of either gender) have provided written informed consent prior to participation in the study undergoing to major lung surgery with an Uniportal VideoThoracocopic Access (UVATS). Exclusion Criteria: rethoracotomy presence of pleural adhesions Neuropathy be a participant in another interventional clinical trial or have received another investigational device or device within the last 30 days (donation of excised tissue [lung or parts of lymph nodes] for biological research may occur in the same patients)

    12. IPD Sharing Statement

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