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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT01761721
First received: January 3, 2013
Last updated: September 1, 2014
Last verified: September 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Denmark
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
  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: September 1, 2014
Health Authority: Denmark: Danish Dataprotection Agency

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

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014