Uterine DiseasesNCT03861195
Comparative Prospective Data Collection in Connection With Two Different Treatment Methods: Robotic Assisted Laparoscopy and Conventional Laparoscopy
An observational study of Uterine Diseases, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
This is a prospective, randomized, single-center, observational clinical trial at the Department of Women's Health of the University Clinic Tübingen. Four hundred patients affected by uterine diseases that undergo treatment with robotic assisted laparoscopic procedures using the Da Vinci Robotic Surgical System (200… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Diseases
- What is being tested?
- laparoscopic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2019to 30 Jun 2023
- 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
- Healthy volunteers accepted
- 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
- 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
This is a prospective, randomized, single-center, observational clinical trial at the Department of Women's Health of the University Clinic Tübingen. Four hundred patients affected by uterine diseases that undergo treatment with robotic assisted laparoscopic procedures using the Da Vinci Robotic Surgical System (200 patients) or conventional laparoscopic surgery (200 patients) will be recruited. In addition retrospective data of 200 patients that underwent conventional laparoscopic surgery in the past will be documented. At the end of patient recruitment, surgical procedure times, the technical limits encountered, 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.
- Conditions
- Uterine Diseases
- Being tested
- laparoscopic surgery
- Medical subject headings
- Uterine Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic surgeryProcedure or surgery
patients affected by uterine diseases that undergo treatment
| Study group | Role | What they receive |
|---|---|---|
| Da Vinci Robotic Surgical System | Not described Receives: Procedure: laparoscopic surgery | |
| conventional laparoscopic surgery | Not described Receives: Procedure: laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
(minutes from first incision to skin closure)
Measured: 60 minutes
time under narcosis
Measured: 60 minutes
console time
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
Measured: 60 minutes
time to discharge
Measured: 60 minutes
intraoperative complications
occurring during the surgical procedure
Measured: 60 minutes
perioperative complications
occurring less than 24h after the surgical procedure, according to the Clavien-Dindo classification of surgical complications
Measured: 24 hours
postoperative complications
occurring more than 24h after the surgical procedure up to 6 months after surgical procedure, according to the Clavien-Dindo classification of surgical complications
Measured: 6 months
German version of the Short Form-36health survey questionnaire Medical Outcomes Trust
Medical Outcomes Trust: SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting.
Measured: 3 and 6 months
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
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start1 Mar 2019
- Primary completion31 Mar 2023
- Study completion30 Jun 2023
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.
- 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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861195
- Sponsor's protocol ID
- MT_SOS I
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2019
- Last updated
- 16 May 2024
- 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 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Prospective Data Collection in Connection With Two Different Treatment Methods: Robotic Assisted Laparoscopy and Conventional Laparoscopy
- ClinicalTrials.gov ID
- NCT03861195
- Acronym / sponsor ID
- MT_SOS I
- Conditions
- Uterine Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 4 Mar 2019 (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, randomized, single-center, observational clinical trial at the Department of Women's Health of the University Clinic Tübingen. Four hundred patients affected by uterine diseases that undergo treatment with robotic assisted laparoscopic procedures using the Da Vinci Robotic Surgical System (200 patients) or conventional laparoscopic surgery (200 patients) will be recruited. In addition retrospective data of 200 patients that underwent conventional laparoscopic surgery in the past will be documented. At the end of patient recruitment, surgical procedure times, the technical limits encountered, 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Da Vinci Robotic Surgical System | – | Procedure: laparoscopic surgery |
| conventional laparoscopic surgery | – | Procedure: laparoscopic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (7 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 |
|---|---|---|
| laparoscopic surgerypatients affected by uterine diseases that undergo treatment | Procedure or surgery | Da Vinci Robotic Surgical System, conventional laparoscopic surgery |
Primary outcome
operative time
Time frame: 60 minutes
(minutes from first incision to skin closure)
time under narcosis
Time frame: 60 minutes
console time
Time frame: 60 minutes
estimated blood loss (milliliters)
Time frame: 60 minutes
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
conversion to other surgical procedures
Time frame: 60 minutes
time to discharge
Time frame: 60 minutes
intraoperative complications
Time frame: 60 minutes
occurring during the surgical procedure
perioperative complications
Time frame: 24 hours
occurring less than 24h after the surgical procedure, according to the Clavien-Dindo classification of surgical complications
postoperative complications
Time frame: 6 months
occurring more than 24h after the surgical procedure up to 6 months after surgical procedure, according to the Clavien-Dindo classification of surgical complications
German version of the Short Form-36health survey questionnaire Medical Outcomes Trust
Time frame: 3 and 6 months
Medical Outcomes Trust: SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting.
German version of the female sexual function index (FSFI) questionnaire
Time frame: 3 and 6 months
female sexual function index: a multidimensional self-report instrument for the assessment of female sexual function
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 16 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 7 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 16 May 2024. 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?
operative time (time frame: 60 minutes). The study lists 11 primary outcomes in all. 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 16 May 2024.