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
• 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

• Endometrial Cancer
• Postoperative Complications
• Treatment by Robotic Assisted Laparoscopy Hysterectomy

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