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

Uterine Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05613816
• Other study ID #: MT_Asensus_Register
• Status: Recruiting
• Start date: September 22, 2022
• Est. completion date: November 2024

Study information

• Verified date: February 2024
• Source: University Hospital Tuebingen
• Contact: Jürgen Andress, Dr
• Phone: 07071 29-82211
• Email: Juergen.andress[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Uterine Diseases

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital Tuebingen, Department of Women's Health	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operating time	time from first incision to skin closure	60 minutes
Secondary	time under narcosis	duration of time in which the study participant is under the influence of a narcotic substance	60 minutes
Secondary	console time	duration of time during which a surgeon is controlling the surgical robot from a console	60 minutes
Secondary	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
Secondary	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
Secondary	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
Secondary	intraoperative complications	(occurring during the surgical procedure)	60 minutes
Secondary	perioperative complications	(occurring less than 24h after the surgical procedure)	24 hours
Secondary	postoperative complications	(occurring more than 24h after the surgical procedure up to 6 months after surgical procedure)	6 months
Secondary	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
Secondary	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
Secondary	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