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

NCT05613816 | Completed

• 1 other identifier: MT_Asensus_Register
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Uterine Diseases

Outcome Measures

Primary Outcomes (1)

• operating time

  time from first incision to skin closure

  60 minutes

Secondary Outcomes (11)

• time under narcosis

  60 minutes

• console time

  60 minutes

• estimated blood loss (milliliters)

  60 minutes

• conversion to other surgical procedures (e. g. open)

  60 minutes

• time to discharge

  60 minutes

Study Arms (1)

Senhance Surgical System

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

Procedure: Senhance Surgical System

Interventions

Senhance Surgical System PROCEDURE

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

Senhance Surgical System

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tuebingen, Department of Women's Health

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Uterine Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Jürgen Andress, Dr

  Department für Frauengesundheit am Universitätsklinikum Tübingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 14, 2022
• Study Start: September 22, 2022
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

DE (1)