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Robot-assisted Laparoscopic Hysterectomy-RALH- Postoperative Complications, Quality of Life and Health Economics

Sponsor
Copenhagen University Hospital at Herlev (Other)
Overall Status
Completed
CT.gov ID
NCT01761721
Collaborator
(none)
139
Enrollment
1
Location
37
Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The propose of this study is to describe recovery and experience of pain and health related quality of life after robot-assisted laparoscopic hysterectomy for women with Endometrial Cancer or Atypical Complex Hyperplasia.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    139 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Robot-assisted Laparoscopic Hysterectomy-RALH- Postoperative Complications, Quality of Life and Health Economics
    Study Start Date :
    Jan 1, 2013
    Actual Primary Completion Date :
    Feb 1, 2016
    Actual Study Completion Date :
    Feb 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    RAHL

    Women suspected of endometrial cancer planned to be treated by robotic assisted laparoscopy hysterectomy

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative complications Postoperative complications Postoperative complications Postoperative complications [0-4 months follow-up]

      Postoperative complications demanding treatment

    Secondary Outcome Measures

    1. Postoperative pain [0-4 months follow-up]

      Postoperative pain measured by Brief Pain Inventory, baseline, 1 and 5 weeks and 4 months postoperatively

    2. Health Related Quality of Life [0-4 months follow-up]

      Health Related Quality of Life measured by QlQ-C30 and EN 24 (EORTC), EQ -5D, baseline, 1 and 5 weeks and 4 months postoperatively.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Women suspected of having Endometrial Cancer or having Atypical Complex hyperplasia

    • Ability to understand and speak Danish

    • Ability to cooperate

    • Provision of written informed consent

    Exclusion Criteria:

    • Having a benign condition after histopathology postoperatively

    • Bing assigned to radiation or chemotherapy postoperatively

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anaesthesiology, Copenhagen University Hospital, Herlev Herlev Denmark 2730

    Sponsors and Collaborators

    • Copenhagen University Hospital at Herlev

    Investigators

    • Principal Investigator: Suzanne F Herling, RN; MHSc, Department of Anaesthesiology, Copenhagen University Hospital, Herlev

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Copenhagen University Hospital at Herlev
    ClinicalTrials.gov Identifier:
    NCT01761721
    Other Study ID Numbers:
    • H-2-2012-FSP26
    First Posted:
    Jan 7, 2013
    Last Update Posted:
    Feb 3, 2016
    Last Verified:
    Feb 1, 2016
    Keywords provided by Copenhagen University Hospital at Herlev
    Endometrial cancer (MeSH)
    Robotics (MeSH)
    Additional relevant MeSH terms:
    Endometrial Neoplasms
    Postoperative Complications

    Study Results

    No Results Posted as of Feb 3, 2016