Comparative Prospective Data Collection in Connection With Two Different Treatment Methods: Robotic Assisted Laparoscopy and Conventional Laparoscopy

University Hospital Tuebingen

Status: Completed

Conditions: Uterine Diseases

Treatments: Procedure: laparoscopic surgery

Study type: Observational

Funder types: Other

Identifiers

NCT03861195

MT_SOS I

Details and patient eligibility

About

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 that undergo treatment with robotic assisted laparoscopic procedures using the Da Vinci Robotic Surgical System (200 patients) or conventional laparoscopic surgery (200 patients) will be recruited. In addition retrospective data of 200 patients that underwent conventional laparoscopic surgery in the past will be documented. At the end of patient recruitment, surgical procedure times, the technical limits encountered, estimated blood loss, intra- and post-operative complications and the percentage of conversions from the robotic assisted treatment /conventional laparoscopic surgery to multiple access and/or to a laparotomic (open) approach will be documented.

Enrollment: 400 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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
• 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

Trial design

400 participants in 2 patient groups

Da Vinci Robotic Surgical System

Treatment:

Procedure: laparoscopic surgery

conventional laparoscopic surgery

Treatment:

Procedure: laparoscopic surgery