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

University Hospital Tuebingen78 enrolled

Overview

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

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

Conditions

Uterine Diseases

Interventions

Senhance Surgical SystemPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Tuebingen, Department of Women's Health

Tübingen, Germany

Outcomes

Primary Outcomes

operating time

time from first incision to skin closure

Time frame: 60 minutes

Secondary Outcomes

time under narcosis

duration of time in which the study participant is under the influence of a narcotic substance

Time frame: 60 minutes

console time

duration of time during which a surgeon is controlling the surgical robot from a console

Time frame: 60 minutes

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

Time frame: 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

Time frame: 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

Time frame: 60 minutes

intraoperative complications

(occurring during the surgical procedure)

Time frame: 60 minutes

perioperative complications

(occurring less than 24h after the surgical procedure)

Data from ClinicalTrials.gov

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