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

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.

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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Treatment by Robotic Assisted Laparoscopy Hysterectomy Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Sex eligibility

Female

Study type

Observational

Primary location

Department of Anaesthesiology, Copenhagen University Hospital, Herlev

Herlev, 2730, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Postoperative complications Postoperative complications Postoperative complications Postoperative complications

Time frame: 0-4 months follow-up

Postoperative complications demanding treatment

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital at Herlev

Other

Registry information

Acronym: RALH

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Jan 7, 2013
Registry last updated: Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed