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NCT01761721 Clinical Trial

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

Endometrial Cancer Clinical Trial

— RALH  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01761721
Other study ID # H-2-2012-FSP26
Secondary ID
Status Completed
Phase N/A
First received January 3, 2013
Last updated February 2, 2016
Start date January 2013
Est. completion date February 2016

Study information
Verified date February 2016
Source Copenhagen University Hospital at Herlev
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 139
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Department of Anaesthesiology, Copenhagen University Hospital, Herlev Herlev

Sponsors (1)
Lead Sponsor Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative complications Postoperative complications Postoperative complications Postoperative complications Postoperative complications demanding treatment 0-4 months follow-up No
Secondary Postoperative pain Postoperative pain measured by Brief Pain Inventory, baseline, 1 and 5 weeks and 4 months postoperatively 0-4 months follow-up No
Secondary Health Related Quality of Life Health Related Quality of Life measured by QlQ-C30 and EN 24 (EORTC), EQ -5D, baseline, 1 and 5 weeks and 4 months postoperatively. 0-4 months follow-up No
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