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

University Hospital Tuebingen

Status: Enrolling

Conditions: Uterine Diseases

Treatments: Procedure: Senhance Surgical System

Study type: Observational

Funder types: Other

Identifiers

NCT05613816

MT_Asensus_Register

Details and patient eligibility

About

This is a prospective, single-center, observational clinical trial at the Department of Women's Health of the University Hospital Tübingen.

Full description

This is a prospective, single-center, observational clinical trial at the Department of Women's Health of the University Hospital Tübingen.

100 patients affected by uterine diseases with indication for hysterectomy undergo treatment with robotically assisted laparoscopic procedures using the Senhance Surgical System (See Synopsis - Indication A) and are compared to a cohort of 200 patients treated with conventional laparoscopic surgery from a similar ongoing study (Ethics vote: 621 /2018BO1).

100 patients affected by other uterine conditions / adnexal conditions that require uterine/adnexal/tubal surgery (see Synopsis - Indication B) undergo treatment with robotically assisted laparoscopic procedures using the Senhance Surgical System and are compared to a cohort of 200 patients with indication for other uterine conditions / adnexal conditions that require uterine/adnexal/tubal surgery (see Synopsis - Indication B) who underwent conventional laparoscopic surgery at the Department of Women's Health in the past.

At the end of patient recruitment, surgical procedure times, 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.

Patients will answer questionnaires (German version of the Short Form-36health survey questionnaire (Medical Outcomes Trust), German version of the female sexual function index (FSFI)) at baseline and at 3 and 6 months of follow-up. A questionnaire for patient satisfaction will be answered one day post procedural, at discharge and at 3 and 6 months follow-up.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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
• 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

Trial design

100 participants in 1 patient group

Senhance Surgical System

Description:

100 patients affected by uterine diseases with indication for hysterectomy undergo treatment with robotically assisted laparoscopic procedures using the Senhance Surgical System

Treatment:

Procedure: Senhance Surgical System