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

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ClinicalTrials.gov Identifier: NCT01761721
Recruitment Status : Completed
First Posted : January 7, 2013
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev

Tracking Information
First Submitted Date January 3, 2013
First Posted Date January 7, 2013
Last Update Posted Date February 3, 2016
Study Start Date January 2013
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 3, 2013)
Postoperative complications Postoperative complications Postoperative complications Postoperative complications [ Time Frame: 0-4 months follow-up ]
Postoperative complications demanding treatment
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 3, 2013)
  • Postoperative pain [ Time Frame: 0-4 months follow-up ]
    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 ]
    Health Related Quality of Life measured by QlQ-C30 and EN 24 (EORTC), EQ -5D, baseline, 1 and 5 weeks and 4 months postoperatively.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Robot-assisted Laparoscopic Hysterectomy-RALH- Postoperative Complications, Quality of Life and Health Economics
Official Title Robot-assisted Laparoscopic Hysterectomy-RALH- Postoperative Complications, Quality of Life and Health Economics
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 4 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women suspected of endometrial cancer and treated with robot-assisted laparoscopic hysterectomy at Copenhagen University Hospital, Herlev.
Condition
  • Endometrial Cancer
  • Treatment by Robotic Assisted Laparoscopy Hysterectomy
Intervention Not Provided
Study Groups/Cohorts RAHL
Women suspected of endometrial cancer planned to be treated by robotic assisted laparoscopy hysterectomy
Publications * Herling SF, Møller AM, Palle C, Thomsen T. Health-related quality of life after robotic-assisted laparoscopic hysterectomy for women with endometrial cancer--A prospective cohort study. Gynecol Oncol. 2016 Jan;140(1):107-13. doi: 10.1016/j.ygyno.2015.10.024. Epub 2015 Nov 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 2, 2016)
139
Original Estimated Enrollment
 (submitted: January 3, 2013)
160
Actual Study Completion Date February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT01761721
Other Study ID Numbers H-2-2012-FSP26
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Copenhagen University Hospital at Herlev
Study Sponsor Copenhagen University Hospital at Herlev
Collaborators Not Provided
Investigators
Principal Investigator: Suzanne F Herling, RN; MHSc Department of Anaesthesiology, Copenhagen University Hospital, Herlev
PRS Account Copenhagen University Hospital at Herlev
Verification Date February 2016