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

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

Study Overview

• Status: Recruiting
• Conditions: Uterine Diseases
• Intervention / Treatment: Procedure: Senhance Surgical System

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Jürgen Andress, Dr; Phone Number: 07071 29-82211; Email: Juergen.andress@med.uni-tuebingen.de
• Study Contact Backup: Name: Bernhard Krämer, Prof. Dr.; Phone Number: 07071 29-82211

Study Locations

• Germany
  • Tübingen, Germany, 72076
    • Recruiting
    • University Hospital Tuebingen, Department of Women's Health
    • Contact: Jürgen Andress, Dr.; Phone Number: 07071 29-82211; Email: Juergen.andress@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 100 patients affected by uterine diseases with indication for hysterectomy undergo treatment with robotically assisted laparoscopic procedures using the Senhance Surgical System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operating time	time from first incision to skin closure	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
estimated blood loss (milliliters)	using the following formula: ((Hemoglobin concentration preoperative (g/l)) - (Hemoglobin 1st day postoperative (g/l)))/((Hemoglobin preoperative (g/l)) - (Hemoglobin 1st day postoperative (g/l)))/2) × 1000	60 minutes
intraoperative complications	(occurring during the surgical procedure)	60 minutes
perioperative complications	(occurring less than 24h after the surgical procedure)	24 hours
postoperative complications	(occurring more than 24h after the surgical procedure up to 6 months after surgical procedure)	6 months
time under narcosis	duration of time in which the study participant is under the influence of a narcotic substance	60 minutes
console time	duration of time during which a surgeon is controlling the surgical robot from a console	60 minutes
conversion to other surgical procedures (e. g. open)	if the original surgical plan during surgery is altered and switched to a different type of surgery to address unforeseen complications or difficulties that arise during the operation	60 minutes
time to discharge	length of time that a patient spends in the hospital before they are well enough to be released and sent home	60 minutes
German version of the Short Form-36health survey questionnaire (Medical Outcomes Trust)	The SF-36 questionnaire (Short Form 36 Health Survey) is a widely used measure of health status and quality of life. The questionnaire consists of 36 items that measure eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. The scores range from 0 to 100 for each domain, with higher scores indicating better health status. Therefore, higher scores on the SF-36 indicate a better outcome.	at baseline, and at 3 and 6 months of follow-up
German version of the female sexual function index (FSFI) questionnaire	female sexual function index: a multidimensional self-report instrument for the assessment of female sexual function; The total composite sexual function score is a sum of domain scores and ranges from 2.0 (not sexually active and no desire) to 36.0. Higher scores on the FSFI indicate better sexual function.	at baseline, and at 3 and 6 months of follow-up
Questionnaire for patient satisfaction	Including A Pain Score ( No Pain 0 - Worst Possible Pain 10) and B Satisfaction with: the severity of the pain; the quality of recovery; the scars; the surgery overall (Scale satisfaction: Extremely dissatisfied -- Dissatisfied -- Somewhat dissatisfied -- Neither satisfied nor dissatisfied -- Somewhat satisfied -- Satisfied -- Extremely satisfied)	at one day post procedural, at discharge and at 3 and 6 months follow-up

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Principal Investigator: Jürgen Andress, Dr, Department für Frauengesundheit am Universitätsklinikum Tübingen

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2022
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: November 4, 2022
• First Submitted That Met QC Criteria: November 4, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Diseases
• Other Study ID Numbers: MT_Asensus_Register

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No