NCT05613816

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

Prospective Data Collection to Compare Robotically Assisted Laparoscopy for Hysterectomies and Other Selected Indications in Comparison to Conventional Laparoscopy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 78 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Uterine Diseases

Interventions

Type	Name	Description
PROCEDURE	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

Timeline

• Start date: 2022-09-22
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2022-11-14
• Last updated: 2026-01-29

Locations

1 site across 1 country: Germany