Status:
COMPLETED
Comparative Prospective Data Collection in Connection With Two Different Treatment Methods: Robotic Assisted Laparoscopy and Conventional Laparoscopy
Lead Sponsor:
University Hospital Tuebingen
Conditions:
Uterine Diseases
Eligibility:
FEMALE
18+ years
Brief Summary
This is a prospective, randomized, single-center, observational clinical trial at the Department of Women's Health of the University Clinic Tübingen. Four hundred patients affected by uterine diseases...
Eligibility Criteria
Inclusion
- age ≥18 years
- BMI ≤40 kg/m2
- indication for hysterectomy for benign disease or prophylactic surgery due to hereditary cancer
- indication for radical hysterectomy and/or pelvic-/para-aortic (sentinel-node) lymphadenectomy for cervical cancer
- indication for modified radical hysterectomy and/or pelvic-/para-aortic (sentinel-node) lymphadenectomy for endometrial cancer
- size of uterus and vagina allows for retrieval by the vaginal route in cancer patients
- written informed consent
Exclusion
- known extensive intra-abdominal adhesions
- anaesthesiological contraindications to laparoscopy
- women with pacemaker or other implants where electrosurgery is to be avoided
- women with known defects of the hemostasis
- pregnancy
- other internal or anatomical criteria that preclude a minimal invasive approach
- inability to understand patient information
Key Trial Info
Start Date :
March 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT03861195
Start Date
March 1 2019
End Date
June 30 2023
Last Update
May 16 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Tuebingen, Department of Women's Health
Tübingen, Germany, 72076