Uterine DiseasesNCT05613816
Prospective Data Collection to Compare RAL for Hysterectomies and Other Indications in to Conventional Laparoscopy
An observational study of Uterine Diseases, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
This is a prospective, single-center, observational clinical trial at the Department of Women's Health of the University Hospital Tübingen. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Diseases
- What is being tested?
- Senhance Surgical System
- Type of treatment
- Surgery or procedure
- How many people
- 78 participants
- Where
- 1 siteGermany
- Study dates
- 22 Sep 2022to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Tuebingen, Department of Women's Health
Tübingen, 72076
About this study
Official title: 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.
Read the 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
- Being tested
- Senhance Surgical System
- Medical subject headings
- Uterine Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senhance Surgical SystemProcedure or surgery
100 patients affected by uterine diseases with indication for hysterectomy undergo treatment with robotically assisted laparoscopic procedures using the Senhance Surgical System
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Senhance Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
operating time
time from first incision to skin closure
Measured: 60 minutes
Secondary outcomes (11)
time under narcosis
duration of time in which the study participant is under the influence of a narcotic substance
Measured: 60 minutes
console time
duration of time during which a surgeon is controlling the surgical robot from a console
Measured: 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
Measured: 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
Measured: 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
Measured: 60 minutes
intraoperative complications
(occurring during the surgical procedure)
Measured: 60 minutes
perioperative complications
(occurring less than 24h after the surgical procedure)
Measured: 24 hours
postoperative complications
(occurring more than 24h after the surgical procedure up to 6 months after surgical procedure)
Measured: 6 months
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.
Measured: 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.
Measured: 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)
Measured: at one day post procedural, at discharge and at 3 and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start22 Sep 2022
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jürgen Andress, Dr, Principal investigator, Department für Frauengesundheit am Universitätsklinikum Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613816
- Sponsor's protocol ID
- MT_Asensus_Register
- Status last verified
- Jan 2026
- First submitted
- 4 Nov 2022
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Data Collection to Compare Robotically Assisted Laparoscopy for Hysterectomies and Other Selected Indications in Comparison to Conventional Laparoscopy
- ClinicalTrials.gov ID
- NCT05613816
- Acronym / sponsor ID
- MT_Asensus_Register
- Conditions
- Uterine Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Senhance Surgical System | – | Procedure: Senhance Surgical System100 patients affected by uterine diseases with indication for hysterectomy undergo treatment with robotically assisted laparoscopic procedures using the Senhance Surgical System |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Senhance Surgical System100 patients affected by uterine diseases with indication for hysterectomy undergo treatment with robotically assisted laparoscopic procedures using the Senhance Surgical System | Procedure or surgery | Senhance Surgical System |
Primary outcome
operating time
Time frame: 60 minutes
time from first incision to skin closure
11 secondary outcomes
time under narcosis
Time frame: 60 minutes
console time
Time frame: 60 minutes
estimated blood loss (milliliters)
Time frame: 60 minutes
conversion to other surgical procedures (e. g. open)
Time frame: 60 minutes
time to discharge
Time frame: 60 minutes
intraoperative complications
Time frame: 60 minutes
perioperative complications
Time frame: 24 hours
postoperative complications
Time frame: 6 months
German version of the Short Form-36health survey questionnaire (Medical Outcomes Trust)
Time frame: at baseline, and at 3 and 6 months of follow-up
German version of the female sexual function index (FSFI) questionnaire
Time frame: at baseline, and at 3 and 6 months of follow-up
Questionnaire for patient satisfaction
Time frame: at one day post procedural, at discharge and at 3 and 6 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jürgen Andress, Dr principal investigator
Department für Frauengesundheit am Universitätsklinikum Tübingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Diseases, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operating time (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.