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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01761721

Acronym

RALH

Enrollment

139

Registered

2013-01-07

Start date

2013-01-31

Completion date

2016-02-29

Last updated

2016-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer, Treatment by Robotic Assisted Laparoscopy Hysterectomy

Keywords

Endometrial cancer (MeSH), Robotics (MeSH)

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Postoperative complications Postoperative complications Postoperative complications Postoperative complications	0-4 months follow-up	Postoperative complications demanding treatment

Secondary

Measure	Time frame	Description
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.

Countries

Denmark

Outcome results