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:


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
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Pathologic Processes

ClinicalTrials.gov processed this record on April 22, 2014