Activity, MotorNCT03373513
Robotic-assisted Hysterectomy: Single- vs. Multi-port Laparoscopic Access
A study testing Robotic single-site Hysterectomy and Laparoscopic hysterectomy in people with Activity, Motor and Pain, run by Herning Hospital at 1 site in Denmark.
Trial summary
robotic single site surgery (R-SSH) is a novel technique, which may be superior to conventional multiport hysterectomy in select patients regarding cosmesis and postoperative pain. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Activity, Motor, Pain, Wound
- What is being tested?
- Robotic single-site Hysterectomy and Laparoscopic hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2019to 1 Dec 2022
- Phase
- Interventional
- 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
Who may be able to join
- hysterectomy on benign indication,
- American Society of Anesthetists group 1 or 2,
- BMI less than 35 kg/m2
- uterine size less than 300 g estimated by ultrasound, using Ferraris formula.
Who cannot join
- adhesions
- prior extensive abdominal surgery
- prior midline incision,
- cutis laxa of abdomen surgery
- endometriosis
- more than 1 cesarean section
- malignant disease
Trial locations and contacts
1 site in 1 country.
About this study
robotic single site surgery (R-SSH) is a novel technique, which may be superior to conventional multiport hysterectomy in select patients regarding cosmesis and postoperative pain. We, perform a randomized trial to compare R-SSH with multiport laparoscopic hysterectomy with regard to the postoperative rehabilitation, cosmesis, the operational cost, and the perioperative morbidity.
Read the detailed description
The study is scheduled to start February 2018 and compares robotic single-site hysterectomy to conventional multiport hysterectomy. Procedures are performed by an experienced two-surgeon team. Patients are randomized to either conventional multiport hysterectomy (N=62) or R-SSH (N=62). Eligibility criteria are the same as for study 1. Patient's satisfaction with body image and cosmesis is assessed at different time points pre- and postoperatively by means of validated cosmesis scales and Body Image Questionnaire. Postoperative pain and analgesia use will be registered as well as secondary outcome parameters as described above. A follow-up at 1, 3 and 6 month include evaluation of the scar and registration of port-site hernias and vaginal dehiscence or other complications. Interviews and diaries will include time of return to home and work, daily activities including sexuality The R-SSH is performed using da Vinci, Xi robotic system. One single port, diameter 2 cm is applied. Applying an additional assistant port is defined conversion of procedure The laparoscopy is performed using our standard equipment and 4 trocars, 5 mm each.
Socio-economical consequences of R-SSH versus conventional laparoscopic hysterectomy Study details in preparation
Sample size calculation was based a previous study on fast track hysterectomy, which showed a difference in return to work of 4 days. 62 women in each group is needed with standard deviation ±8 and a power of 80%. To include those not working, we calculated that with an expected visual analog pain score of 0.86 ±0.2 and 62 in each group the sample was sufficient to detect of difference of 0.1 in visual analog pain score with a power of 80%. All calculation are based on two-sided testing with alpha of 0.05.
- Conditions
- Activity, Motor, Pain, Wound
- Being tested
- Robotic single-site Hysterectomy, Laparoscopic hysterectomy
- Keywords
- Return-to-work, Visual analogue pain score, Cosmesis
- Medical subject headings
- Motor Activity, Pain, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic single-site HysterectomyProcedure or surgery
Robotic assisted Periumbilical single incision hysterectomy
Laparoscopic hysterectomyProcedure or surgery
Multiport laparoscopic hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| Robotic single-site hysterectomy | Active comparator | Robotic single-site hysterectomy is performed in this arm Receives: Procedure: Robotic single-site Hysterectomy |
| Multiport Laparoscopy | Active comparator | Multiport Laparoscopic hysterectomy is performed in this other arm Receives: Procedure: Laparoscopic hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return-to-work
Time from operation to return work
Measured: up to six months after operation or until work is resumed, whichever came first
Secondary outcomes (1)
Pain measured by subjective score
Visual analogue pain score with a minimum of '0' up to '10' on a 10 cm continious scale
Measured: Visual analogue pain score first, second, third, fourth, fifth, and six months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start1 Feb 2019 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Why it stopped: hospital never sterted on single site laparoscopy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Activity, MotorStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Women are randomized to either robotic single site or multi port lapsoscopic hystrectomy
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herning Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Finn Lauszus, Herning Hospital
- Investigators
- Finn F Lauszus, MD,PhD, Principal investigator, Gynecology Department, Herning Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373513
- Sponsor's protocol ID
- R-SSH
- Status last verified
- Oct 2024
- First submitted
- 7 Dec 2017
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: via meeting, posters, abstracts, and publications
Publications
El Hachem L, Andikyan V, Mathews S, Friedman K, Poeran J, Shieh K, Geoghegan M, Gretz HF 3rd. Robotic Single-Site and Conventional Laparoscopic Surgery in Gynecology: Clinical Outcomes and Cost Analysis of a Matched Case-Control Study. J Minim Invasive Gynecol. 2016 Jul-Aug;23(5):760-8. doi: 10.1016/j.jmig.2016.03.005. Epub 2016 Mar 15.
PubMed 26992935Golkar FC, Ross SB, Sperry S, Vice M, Luberice K, Donn N, Morton C, Hernandez JM, Rosemurgy AS. Patients' perceptions of laparoendoscopic single-site surgery: the cosmetic effect. Am J Surg. 2012 Nov;204(5):751-61. doi: 10.1016/j.amjsurg.2011.07.026.
PubMed 23140831Sandberg EM, la Chapelle CF, van den Tweel MM, Schoones JW, Jansen FW. Laparoendoscopic single-site surgery versus conventional laparoscopy for hysterectomy: a systematic review and meta-analysis. Arch Gynecol Obstet. 2017 May;295(5):1089-1103. doi: 10.1007/s00404-017-4323-y. Epub 2017 Mar 29.
PubMed 28357561Yeung PP Jr, Bolden CR, Westreich D, Sobolewski C. Patient preferences of cosmesis for abdominal incisions in gynecologic surgery. J Minim Invasive Gynecol. 2013 Jan-Feb;20(1):79-84. doi: 10.1016/j.jmig.2012.09.008.
PubMed 23312246Aarts JW, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2015 Aug 12;2015(8):CD003677. doi: 10.1002/14651858.CD003677.pub5.
PubMed 26264829
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-assisted Hysterectomy: Single- vs. Multi-port Laparoscopic Access
- ClinicalTrials.gov ID
- NCT03373513
- Acronym / sponsor ID
- R-SSH
- Conditions
- Activity, Motor, Pain, Wound
- Keywords
- Return-to-work, Visual analogue pain score, Cosmesis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: hospital never sterted on single site laparoscopy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Herning HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 14 Dec 2017 (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.
robotic single site surgery (R-SSH) is a novel technique, which may be superior to conventional multiport hysterectomy in select patients regarding cosmesis and postoperative pain. We, perform a randomized trial to compare R-SSH with multiport laparoscopic hysterectomy with regard to the postoperative rehabilitation, cosmesis, the operational cost, and the perioperative morbidity.
Detailed description
The study is scheduled to start February 2018 and compares robotic single-site hysterectomy to conventional multiport hysterectomy. Procedures are performed by an experienced two-surgeon team. Patients are randomized to either conventional multiport hysterectomy (N=62) or R-SSH (N=62). Eligibility criteria are the same as for study 1. Patient's satisfaction with body image and cosmesis is assessed at different time points pre- and postoperatively by means of validated cosmesis scales and Body Image Questionnaire. Postoperative pain and analgesia use will be registered as well as secondary outcome parameters as described above. A follow-up at 1, 3 and 6 month include evaluation of the scar and registration of port-site hernias and vaginal dehiscence or other complications. Interviews and diaries will include time of return to home and work, daily activities including sexuality The R-SSH is performed using da Vinci, Xi robotic system. One single port, diameter 2 cm is applied. Applying an additional assistant port is defined conversion of procedure The laparoscopy is performed using our standard equipment and 4 trocars, 5 mm each.
Socio-economical consequences of R-SSH versus conventional laparoscopic hysterectomy Study details in preparation
Sample size calculation was based a previous study on fast track hysterectomy, which showed a difference in return to work of 4 days. 62 women in each group is needed with standard deviation ±8 and a power of 80%. To include those not working, we calculated that with an expected visual analog pain score of 0.86 ±0.2 and 62 in each group the sample was sufficient to detect of difference of 0.1 in visual analog pain score with a power of 80%. All calculation are based on two-sided testing with alpha of 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Women are randomized to either robotic single site or multi port lapsoscopic hystrectomy
| Arm | Type | Receives |
|---|---|---|
| Robotic single-site hysterectomy | Active comparator | Procedure: Robotic single-site HysterectomyRobotic single-site hysterectomy is performed in this arm |
| Multiport Laparoscopy | Active comparator | Procedure: Laparoscopic hysterectomyMultiport Laparoscopic hysterectomy is performed in this other arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- hysterectomy on benign indication,
- American Society of Anesthetists group 1 or 2,
- BMI less than 35 kg/m2
- uterine size less than 300 g estimated by ultrasound, using Ferraris formula.
Key exclusion criteria (7 listed)
- adhesions
- prior extensive abdominal surgery
- prior midline incision,
- cutis laxa of abdomen surgery
- endometriosis
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 |
|---|---|---|
| Robotic single-site HysterectomyRobotic assisted Periumbilical single incision hysterectomy | Procedure or surgery | Robotic single-site hysterectomy |
| Laparoscopic hysterectomyMultiport laparoscopic hysterectomy | Procedure or surgery | Multiport Laparoscopy |
Primary outcome
Return-to-work
Time frame: up to six months after operation or until work is resumed, whichever came first
Time from operation to return work
1 secondary outcome
Pain measured by subjective score
Time frame: Visual analogue pain score first, second, third, fourth, fifth, and six months after operation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Background: PubMed 26992935El Hachem L, Andikyan V, Mathews S, Friedman K, Poeran J, Shieh K, Geoghegan M, Gretz HF 3rd. Robotic Single-Site and Conventional Laparoscopic Surgery in Gynecology: Clinical Outcomes and Cost Analysis of a Matched Case-Control Study. J Minim Invasive Gynecol. 2016 Jul-Aug;23(5):760-8. doi: 10.1016/j.jmig.2016.03.005. Epub 2016 Mar 15.
- Background: PubMed 23140831Golkar FC, Ross SB, Sperry S, Vice M, Luberice K, Donn N, Morton C, Hernandez JM, Rosemurgy AS. Patients' perceptions of laparoendoscopic single-site surgery: the cosmetic effect. Am J Surg. 2012 Nov;204(5):751-61. doi: 10.1016/j.amjsurg.2011.07.026.
- Background: PubMed 28357561Sandberg EM, la Chapelle CF, van den Tweel MM, Schoones JW, Jansen FW. Laparoendoscopic single-site surgery versus conventional laparoscopy for hysterectomy: a systematic review and meta-analysis. Arch Gynecol Obstet. 2017 May;295(5):1089-1103. doi: 10.1007/s00404-017-4323-y. Epub 2017 Mar 29.
- Background: PubMed 23312246Yeung PP Jr, Bolden CR, Westreich D, Sobolewski C. Patient preferences of cosmesis for abdominal incisions in gynecologic surgery. J Minim Invasive Gynecol. 2013 Jan-Feb;20(1):79-84. doi: 10.1016/j.jmig.2012.09.008.
- Background: PubMed 26264829Aarts JW, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2015 Aug 12;2015(8):CD003677. doi: 10.1002/14651858.CD003677.pub5.
- Individual participant dataSharing planned: Undecided. via meeting, posters, abstracts, and publications
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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.
Finn F Lauszus, MD,PhD principal investigator
Gynecology Department, Herning Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic single-site Hysterectomy and Laparoscopic hysterectomy in people with Activity, Motor and Pain, run by Herning Hospital at 1 site in Denmark.
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 4 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: withdrawn, as of the sponsor's last update on 16 Oct 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 Denmark. 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 was withdrawn before enrolling participants, so there are no results.
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?
Return-to-work (time frame: up to six months after operation or until work is resumed, whichever came first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03373513, which also lists 5 linked publications.
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 Oct 2024.