Prospective Data Collection to Compare RAL for Hysterectomies and Other Indications in to Conventional Laparoscopy

Launched by UNIVERSITY HOSPITAL TUEBINGEN · Nov 4, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a type of surgery called robotic-assisted laparoscopy (RAL) for women who need a hysterectomy or other surgeries related to uterine diseases. The goal is to compare the outcomes of this robotic method with traditional laparoscopy, which is a less invasive surgery. The trial is taking place at the University Hospital Tübingen and is currently recruiting participants aged 18 and older who have specific medical conditions that require surgery. These conditions include benign diseases, cancers of the cervix or endometrium, and various other uterine issues.

To participate in this study, women should be within a certain weight range (BMI ≤ 40) and able to provide written consent. However, some individuals may not be eligible if they have certain medical conditions, such as extensive internal scarring or pregnancy, or if they cannot understand the information provided about the trial. Participants in the trial can expect to undergo surgery using the robotic technique, and their experiences will be monitored and compared to those who have traditional laparoscopic surgery. This research aims to improve surgical options and outcomes for women with uterine diseases.

Gender

FEMALE

Eligibility criteria

• 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