Prospective Data Collection to Compare RAL for Hysterectomies and Other Indications in to Convent… (NCT05613816) | Clinical Trial Compass
CompletedNot Applicable
Prospective Data Collection to Compare RAL for Hysterectomies and Other Indications in to Conventional Laparoscopy
Germany78 participantsStarted 2022-09-22
Plain-language summary
This is a prospective, single-center, observational clinical trial at the Department of Women's Health of the University Hospital Tübingen.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* 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
* indication for other uterine conditions / adnexal conditions that require uterine/adnexal/tubal surgery: Fibroids, Endometriomas, Cystic masses, Ectopic pregnancies, Sactosalpinx, Inflammatory adnexal disease, Opportunistic salpingectomy as part of hysterectomy or exclusively, Cervico-/Sacrokolpopexy
* size of uterus and vagina allows for retrieval by the vaginal route in cancer patients
* written informed consent
Exclusion Criteria:
* 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