Robot-assisted Laparoscopic Hysterectomy-RALH- Postoperative Complications, Quality of Life and Health Economics (RALH)
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ClinicalTrials.gov Identifier: NCT01761721 |
Recruitment Status :
Completed
First Posted : January 7, 2013
Last Update Posted : February 3, 2016
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Condition or disease |
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Endometrial Cancer Treatment by Robotic Assisted Laparoscopy Hysterectomy |
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 139 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 4 Months |
Official Title: | Robot-assisted Laparoscopic Hysterectomy-RALH- Postoperative Complications, Quality of Life and Health Economics |
Study Start Date : | January 2013 |
Actual Primary Completion Date : | February 2016 |
Actual Study Completion Date : | February 2016 |

Group/Cohort |
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RAHL
Women suspected of endometrial cancer planned to be treated by robotic assisted laparoscopy hysterectomy
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- Postoperative complications Postoperative complications Postoperative complications Postoperative complications [ Time Frame: 0-4 months follow-up ]Postoperative complications demanding treatment
- 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.

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761721
Denmark | |
Department of Anaesthesiology, Copenhagen University Hospital, Herlev | |
Herlev, Denmark, 2730 |
Principal Investigator: | Suzanne F Herling, RN; MHSc | Department of Anaesthesiology, Copenhagen University Hospital, Herlev |
Publications of Results:
Responsible Party: | Copenhagen University Hospital at Herlev |
ClinicalTrials.gov Identifier: | NCT01761721 |
Other Study ID Numbers: |
H-2-2012-FSP26 |
First Posted: | January 7, 2013 Key Record Dates |
Last Update Posted: | February 3, 2016 |
Last Verified: | February 2016 |
Endometrial cancer (MeSH) Robotics (MeSH) |
Endometrial Neoplasms Postoperative Complications Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site Neoplasms Uterine Diseases Pathologic Processes |