RehabilitationNCT03662451
Single Site Versus Multi Site Robotic Hysterectomy
A study testing Robotic assisted hysterectomy in people with Rehabilitation and Pain, Postoperative, 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 multi site hysterectomy (R-MSH) in select patients regarding cosmesis and postoperative pain. A randomized trial is performed to compare R-SSH with R-MSH with regard to the postoperative rehabilitation, cosmesis, the operational cost… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Rehabilitation, Pain, Postoperative, Wound Infection
- What is being tested?
- Robotic assisted 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
- 15 Oct 2024to 1 Nov 2026
- 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 to 85 years
- 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 30 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 multi site hysterectomy (R-MSH) in select patients regarding cosmesis and postoperative pain. A randomized trial is performed to compare R-SSH with R-MSH with regard to the postoperative rehabilitation, cosmesis, the operational cost, and the perioperative morbidity.
Read the detailed description
The study is scheduled to start November 2018 and compares robotic single site to multi site hysterectomy. Procedures are performed on two locations, Herning and Herlev Hospitals, by experienced surgeons. Patients are randomized to either R-SSH (No.=62) or R-MSH (No.=62). 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 and photo-evaluations.
Postoperative pain and split times spent at the operation theatre will be registered as secondary outcome parameters.
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 R-MSH is performed using standard equipment and 4 trocars, 5 mm each.
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, the calculation was performed with an expected visual analog pain score of 0.86 ±0.2 and 62 in each group and suggested that 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
- Rehabilitation, Pain, Postoperative, Wound Infection
- Being tested
- Robotic assisted hysterectomy
- Keywords
- Return-to-work, Cosmesis, Visual analogue pain score
- Medical subject headings
- Pain, Postoperative, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic assisted hysterectomyProcedure or surgery
Periumbilical single incision vs multiple abdominal incisions for 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 assisted hysterectomy |
| Robotic multi-site hysterectomy | Active comparator | Robotic multi-site hysterectomy is performed in this arm Receives: Procedure: Robotic assisted hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar appearance and satisfaction
Appearance and evaluation of scar by POSAS scale (see www.posas.org and reference below) which has a scale from 1-10, where 1 is minimum and 10 is maximum; on scar's pain, its itching, on difference from normal skin, on stiffness, on thickness, on irregularity and general satisfaction
Measured: Six months after operation
Secondary outcomes (1)
Scoring of abdominal pain
Visual analogue pain score with a minimum '0' and maximum '10'
Measured: Visual analogue pain score at first, second, third, fourth, fifth, and sixth month after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start15 Oct 2024 (estimated)
- Primary completion16 Oct 2024 (estimated)
- Study completion1 Nov 2026 (estimated)
Why it stopped: Hospital never started on single site laparoscopy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for RehabilitationStudies 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 site hysterectomy
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herning Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital
- Responsible party
- Principal investigator, Finn Lauszus, Herning Hospital
- Investigators
- Finn F Lauszus, PhD, Principal investigator, Herning Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662451
- Sponsor's protocol ID
- Single site robot study
- Status last verified
- Oct 2024
- First submitted
- 7 Jun 2018
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Awaiting consensus in the steering Group on 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 26264829Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010 Jun 21;10:e43.
PubMed 20596233
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
- Single Site Versus Multi Site Robotic Hysterectomy
- ClinicalTrials.gov ID
- NCT03662451
- Acronym / sponsor ID
- Single site robot study
- Conditions
- Rehabilitation, Pain, Postoperative, Wound Infection
- Keywords
- Return-to-work, Cosmesis, Visual analogue pain score
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Hospital never started on single site laparoscopy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Herning HospitalUniversity, hospital or other
- Collaborators
- Herlev Hospital
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 16 Oct 2024 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 7 Sep 2018 (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 multi site hysterectomy (R-MSH) in select patients regarding cosmesis and postoperative pain. A randomized trial is performed to compare R-SSH with R-MSH with regard to the postoperative rehabilitation, cosmesis, the operational cost, and the perioperative morbidity.
Detailed description
The study is scheduled to start November 2018 and compares robotic single site to multi site hysterectomy. Procedures are performed on two locations, Herning and Herlev Hospitals, by experienced surgeons. Patients are randomized to either R-SSH (No.=62) or R-MSH (No.=62). 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 and photo-evaluations.
Postoperative pain and split times spent at the operation theatre will be registered as secondary outcome parameters.
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 R-MSH is performed using standard equipment and 4 trocars, 5 mm each.
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, the calculation was performed with an expected visual analog pain score of 0.86 ±0.2 and 62 in each group and suggested that 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 site hysterectomy
| Arm | Type | Receives |
|---|---|---|
| Robotic single-site hysterectomy | Active comparator | Procedure: Robotic assisted hysterectomyRobotic single-site hysterectomy is performed in this arm |
| Robotic multi-site hysterectomy | Active comparator | Procedure: Robotic assisted hysterectomyRobotic multi-site hysterectomy is performed in this arm |
Who may qualify
- Ages
- 18 to 85 years
- 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 30 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 assisted hysterectomyPeriumbilical single incision vs multiple abdominal incisions for hysterectomy | Procedure or surgery | Robotic multi-site hysterectomy, Robotic single-site hysterectomy |
Primary outcome
Scar appearance and satisfaction
Time frame: Six months after operation
Appearance and evaluation of scar by POSAS scale (see www.posas.org and reference below) which has a scale from 1-10, where 1 is minimum and 10 is maximum; on scar's pain, its itching, on difference from normal skin, on stiffness, on thickness, on irregularity and general satisfaction
1 secondary outcome
Scoring of abdominal pain
Time frame: Visual analogue pain score at first, second, third, fourth, fifth, and sixth month 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.
- Background: PubMed 20596233Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010 Jun 21;10:e43.
- Individual participant dataSharing planned: Undecided. Awaiting consensus in the steering Group on 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, PhD principal investigator
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 assisted hysterectomy in people with Rehabilitation and Pain, Postoperative, 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?
Scar appearance and satisfaction (time frame: Six months after operation). 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 NCT03662451, which also lists 6 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.