Clinical trial NCT05613816: Prospective Data Collection to Compare RAL for Hysterectomies and Other Indications in to Conventional Laparoscopy
Official title: Prospective Data Collection to Compare Robotically Assisted Laparoscopy for Hysterectomies and Other Selected Indications in Comparison to Conventional Laparoscopy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Uterine Diseases
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: operating time
timeFrame: 60 minutes
Secondary outcomes:
measure: time under narcosis
timeFrame: 60 minutes
measure: console time
timeFrame: 60 minutes
measure: estimated blood loss (milliliters)
timeFrame: 60 minutes
measure: conversion to other surgical procedures (e. g. open)
timeFrame: 60 minutes
measure: time to discharge
timeFrame: 60 minutes
measure: intraoperative complications
timeFrame: 60 minutes
measure: perioperative complications
timeFrame: 24 hours
measure: postoperative complications
timeFrame: 6 months
measure: German version of the Short Form-36health survey questionnaire (Medical Outcomes Trust)
timeFrame: at baseline, and at 3 and 6 months of follow-up
measure: German version of the female sexual function index (FSFI) questionnaire
timeFrame: at baseline, and at 3 and 6 months of follow-up
measure: Questionnaire for patient satisfaction
timeFrame: at one day post procedural, at discharge and at 3 and 6 months follow-up
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tuebingen, Department of Women's Health
Study officials:
affiliation: Department für Frauengesundheit am Universitätsklinikum Tübingen
name: Jürgen Andress, Dr
role: PRINCIPAL_INVESTIGATOR
References: