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

Completed

• Conditions: Treatment by Robotic Assisted Laparoscopy Hysterectomy; Endometrial Cancer

• Registration Number: NCT01761721
• Lead Sponsor: Copenhagen University Hospital at Herlev

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 available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-03
• Study First Submitted QC: 2013-01-03
• Study First Posted: 2013-01-07
• Status Verified: 2016-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-02-02
• Last Update Posted: 2016-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 139

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative complications Postoperative complications Postoperative complications Postoperative complications	0-4 months follow-up	Postoperative complications demanding treatment

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	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	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.

Trial Locations

Locations (1)

Department of Anaesthesiology, Copenhagen University Hospital, Herlev; 🇩🇰 Herlev, Denmark