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

This study is currently recruiting participants.
Verified January 2013 by Copenhagen University Hospital at Herlev
Sponsor:
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT01761721
First received: January 3, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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
Endometrial Cancer
Treatment by Robotic Assisted Laparoscopy Hysterectomy

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Months
Official Title: Robot-assisted Laparoscopic Hysterectomy-RALH- Postoperative Complications, Quality of Life and Health Economics

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • Postoperative complications Postoperative complications Postoperative complications Postoperative complications [ Time Frame: 0-4 months follow-up ] [ Designated as safety issue: No ]
    Postoperative complications demanding treatment


Secondary Outcome Measures:
  • Postoperative pain [ Time Frame: 0-4 months follow-up ] [ Designated as safety issue: No ]
    Postoperative pain measured by Brief Pain Inventory, baseline, 1 and 5 weeks and 4 months postoperatively

  • Health Related Quality of Life [ Time Frame: 0-4 months follow-up ] [ Designated as safety issue: No ]
    Health Related Quality of Life measured by QlQ-C30 and EN 24 (EORTC), EQ -5D, baseline, 1 and 5 weeks and 4 months postoperatively.


Estimated Enrollment: 160
Study Start Date: January 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
RAHL
Women suspected of endometrial cancer planned to be treated by robotic assisted laparoscopy hysterectomy

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women suspected of endometrial cancer and treated with robot-assisted laparoscopic hysterectomy at Copenhagen University Hospital, Herlev.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761721

Contacts
Contact: Suzanne F Herling, RN; MHSc +45 38683595 Suzanne.forsyth.herling@regionh.dk
Contact: Ann M Moeller, DMSc +45 38682879 annmoeller@regionh.dk

Locations
Denmark
Department of Anaesthesiology, Copenhagen University Hospital, Herlev Recruiting
Herlev, Denmark, 2730
Contact: Suzanne F Herling, RN; MHSc     +45 38683595     Suzanne.forsyth.herling@regionh.dk    
Contact: Ann M Moeller, DMSc     +45 38682879     annmoeller@regionh.dk    
Principal Investigator: Suzanne F Herling, RN; MHSc            
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Investigators
Principal Investigator: Suzanne F Herling, RN; MHSc Department of Anaesthesiology, Copenhagen University Hospital, Herlev
  More Information

No publications provided

Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01761721     History of Changes
Other Study ID Numbers: H-2-2012-FSP26
Study First Received: January 3, 2013
Last Updated: January 3, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Copenhagen University Hospital at Herlev:
Endometrial cancer (MeSH)
Robotics (MeSH)

Additional relevant MeSH terms:
Endometrial Neoplasms
Postoperative Complications
Adenoma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Diseases
Genital Diseases, Female
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 23, 2013