Physical ActivitySTIRUPPSNCT03446950
Study Investigating Role of Unalike Patient Positioning on PROMIS Scores
A study testing Vaginal Surgery in people with Physical Activity and Surgery, run by University of Louisville at 1 site in United States.
Trial summary
The primary objective is to assess the impact of patient positioning using the candy cane stirrups as compared to boot stirrups on physical functioning outcomes at 6 weeks post-op 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
- Physical Activity, Surgery, Vaginal Hysterectomy
- What is being tested?
- Vaginal Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2018to 4 May 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- English speaking
- Scheduled to undergo vaginal or urological surgery with University of Louisville Urogynecology physicians
Who cannot join
- Immobile or wheelchair bound
- Pre-existing neurological condition limiting physical function
- Age < 18 years
- Patient's with dementia or unable to give informed consent
- Non-English speaking
- Unwilling to follow up in 6 weeks
Show all 9Show fewer
- Patient's undergoing laparoscopic, robotic or abdominal surgery or surgery through a combined approach
- Patients undergoing surgery under local anesthesia
- Patients who will be awake during positioning
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville Physicians
Louisville, Kentucky, 40205
About this study
Official title: Candy Cane vs. Boot Stirrups in Vaginal Surgery: A Randomized Control Trial
The primary objective is to assess the impact of patient positioning using the candy cane stirrups as compared to boot stirrups on physical functioning outcomes at 6 weeks post-op
Read the detailed description
Patient positioning is an important component of vaginal surgery allowing the surgeon access to the vagina while minimizing patient discomfort and neurological injury. The data on appropriate patient positioning for gynecological vaginal surgery is limited with most providers basing the choice between candy cane and boot stirrups on personal preference. This study has the following aims:
- Aim 1: To perform a randomized controlled trial comparing candy cane stirrups to boot stirrups in patients undergoing vaginal surgery with the primary outcome of change in physical function at 6 weeks post-op as measured by the Patient-Reported Outcomes Measurement and Information System (PROMIS®) 20-Item Physical Functioning Short-Form.
- Aim 2: The investigators aim to measure the angles at the level of hip, knee and foot joints during the surgery in both the candy cane and boot stirrups to assess any association between angles and physical function
- Conditions
- Physical Activity, Surgery, Vaginal Hysterectomy, Vaginal Surgery
- Being tested
- Vaginal Surgery
- Keywords
- vaginal surgery, patient position, stirrups, functional status, urogynecology
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal SurgeryProcedure or surgery
Patients will undergo elective surgery on vagina or bladder
| Study group | Role | What they receive |
|---|---|---|
| Candy Cane | Active comparator | Participants in this arm will be positioned with their legs in candy cane stirrups. Patients will then undergo scheduled vaginal surgery and be asked to complete PROMIS questionnaires before and after surgery. Receives: Procedure: Vaginal Surgery |
| Boot Stirrups | Active comparator | Participants in this arm will have their feet placed in boot stirrups. Patients will then undergo scheduled vaginal surgery and be asked to complete PROMIS questionnaires before and after surgery. Receives: Procedure: Vaginal Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient-Reported Outcomes Measurement and Information System(PROMIS) Physical Function Scale
Patients will complete the 20 point Physical Function short form. The minimum score for this scale is 20 and maximum score is 100. A higher score is associated with a better physical function outcome.
Measured: preop and 6 weeks post op
Secondary outcomes (1)
Angles of positioning
angles at the level of hip, knee and foot joints during the surgery in both the candy cane and boot stirrups to assess any association between angles and physical function
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start6 Mar 2018
- Primary completion22 Nov 2019
- Study completion4 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To compare patient positioning during vaginal surgery we plan to conduct a single site single blinded randomized controlled trial where patients planning elective vaginal surgery will be randomized to be positioned in Candy cane or Boot stirrups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Francis, University of Louisville
- Investigators
- Sean L Francis, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446950
- Sponsor's protocol ID
- 18.0061
- Acronym
- STIRUPPS
- Status last verified
- Jun 2020
- First submitted
- 11 Feb 2018
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fleisch MC, Bremerich D, Schulte-Mattler W, Tannen A, Teichmann AT, Bader W, Balzer K, Renner SP, Romer T, Roth S, Schutz F, Thill M, Tinneberg H, Zarras K. The Prevention of Positioning Injuries during Gynecologic Operations. Guideline of DGGG (S1-Level, AWMF Registry No. 015/077, February 2015). Geburtshilfe Frauenheilkd. 2015 Aug;75(8):792-807. doi: 10.1055/s-0035-1557776.
PubMed 26365999Bohrer JC, Walters MD, Park A, Polston D, Barber MD. Pelvic nerve injury following gynecologic surgery: a prospective cohort study. Am J Obstet Gynecol. 2009 Nov;201(5):531.e1-7. doi: 10.1016/j.ajog.2009.07.023. Epub 2009 Sep 17.
PubMed 19761997Gumus E, Kendirci M, Horasanli K, Tanriverdi O, Gidemez G, Miroglu C. Neurapraxic complications in operations performed in the lithotomy position. World J Urol. 2002 May;20(1):68-71. doi: 10.1007/s00345-001-0241-4.
PubMed 12088195Cardosi RJ, Cox CS, Hoffman MS. Postoperative neuropathies after major pelvic surgery. Obstet Gynecol. 2002 Aug;100(2):240-4. doi: 10.1016/s0029-7844(02)02052-5.
PubMed 12151144Litwiller JP, Wells RE Jr, Halliwill JR, Carmichael SW, Warner MA. Effect of lithotomy positions on strain of the obturator and lateral femoral cutaneous nerves. Clin Anat. 2004 Jan;17(1):45-9. doi: 10.1002/ca.10168.
PubMed 14695587Power H. Patient positioning outcomes for women undergoing gynaecological surgeries. Can Oper Room Nurs J. 2002 Sep;20(3):7-10, 27-30.
PubMed 12271555Sung VW, Wohlrab KJ, Madsen A, Raker C. Patient-reported goal attainment and comprehensive functioning outcomes after surgery compared with pessary for pelvic organ prolapse. Am J Obstet Gynecol. 2016 Nov;215(5):659.e1-659.e7. doi: 10.1016/j.ajog.2016.06.013. Epub 2016 Jun 16.
PubMed 27319365Gupta A, Meriwether K, Tuller M, Sekula M, Gaskins J, Stewart JR, Hobson D, Cardenas-Trowers O, Francis S. Candy Cane Compared With Boot Stirrups in Vaginal Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2020 Aug;136(2):333-341. doi: 10.1097/AOG.0000000000003954.
PubMed 32649498
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Candy Cane vs. Boot Stirrups in Vaginal Surgery: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03446950
- Acronym / sponsor ID
- STIRUPPS / 18.0061
- Conditions
- Physical Activity, Surgery, Vaginal Hysterectomy, Vaginal Surgery
- Keywords
- vaginal surgery, patient position, stirrups, functional status, urogynecology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 4 May 2020 (actual)
- First posted
- 27 Feb 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.
The primary objective is to assess the impact of patient positioning using the candy cane stirrups as compared to boot stirrups on physical functioning outcomes at 6 weeks post-op
Detailed description
Patient positioning is an important component of vaginal surgery allowing the surgeon access to the vagina while minimizing patient discomfort and neurological injury. The data on appropriate patient positioning for gynecological vaginal surgery is limited with most providers basing the choice between candy cane and boot stirrups on personal preference. This study has the following aims:
- Aim 1: To perform a randomized controlled trial comparing candy cane stirrups to boot stirrups in patients undergoing vaginal surgery with the primary outcome of change in physical function at 6 weeks post-op as measured by the Patient-Reported Outcomes Measurement and Information System (PROMIS®) 20-Item Physical Functioning Short-Form.
- Aim 2: The investigators aim to measure the angles at the level of hip, knee and foot joints during the surgery in both the candy cane and boot stirrups to assess any association between angles and physical function
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- To compare patient positioning during vaginal surgery we plan to conduct a single site single blinded randomized controlled trial where patients planning elective vaginal surgery will be randomized to be positioned in Candy cane or Boot stirrups
| Arm | Type | Receives |
|---|---|---|
| Candy Cane | Active comparator | Procedure: Vaginal SurgeryParticipants in this arm will be positioned with their legs in candy cane stirrups. Patients will then undergo scheduled vaginal surgery and be asked to complete PROMIS questionnaires before and after surgery. |
| Boot Stirrups | Active comparator | Procedure: Vaginal SurgeryParticipants in this arm will have their feet placed in boot stirrups. Patients will then undergo scheduled vaginal surgery and be asked to complete PROMIS questionnaires before and after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- English speaking
- Scheduled to undergo vaginal or urological surgery with University of Louisville Urogynecology physicians
Key exclusion criteria (9 listed)
- Immobile or wheelchair bound
- Pre-existing neurological condition limiting physical function
- Age < 18 years
- Patient's with dementia or unable to give informed consent
- Non-English speaking
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 |
|---|---|---|
| Vaginal SurgeryPatients will undergo elective surgery on vagina or bladder | Procedure or surgery | Boot Stirrups, Candy Cane |
Primary outcome
Change in Patient-Reported Outcomes Measurement and Information System(PROMIS) Physical Function Scale
Time frame: preop and 6 weeks post op
Patients will complete the 20 point Physical Function short form. The minimum score for this scale is 20 and maximum score is 100. A higher score is associated with a better physical function outcome.
1 secondary outcome
Angles of positioning
Time frame: Intra-operative
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 9 Jun 2020.
- Background: PubMed 26365999Fleisch MC, Bremerich D, Schulte-Mattler W, Tannen A, Teichmann AT, Bader W, Balzer K, Renner SP, Romer T, Roth S, Schutz F, Thill M, Tinneberg H, Zarras K. The Prevention of Positioning Injuries during Gynecologic Operations. Guideline of DGGG (S1-Level, AWMF Registry No. 015/077, February 2015). Geburtshilfe Frauenheilkd. 2015 Aug;75(8):792-807. doi: 10.1055/s-0035-1557776.
- Background: PubMed 19761997Bohrer JC, Walters MD, Park A, Polston D, Barber MD. Pelvic nerve injury following gynecologic surgery: a prospective cohort study. Am J Obstet Gynecol. 2009 Nov;201(5):531.e1-7. doi: 10.1016/j.ajog.2009.07.023. Epub 2009 Sep 17.
- Background: PubMed 12088195Gumus E, Kendirci M, Horasanli K, Tanriverdi O, Gidemez G, Miroglu C. Neurapraxic complications in operations performed in the lithotomy position. World J Urol. 2002 May;20(1):68-71. doi: 10.1007/s00345-001-0241-4.
- Background: PubMed 12151144Cardosi RJ, Cox CS, Hoffman MS. Postoperative neuropathies after major pelvic surgery. Obstet Gynecol. 2002 Aug;100(2):240-4. doi: 10.1016/s0029-7844(02)02052-5.
- Background: PubMed 14695587Litwiller JP, Wells RE Jr, Halliwill JR, Carmichael SW, Warner MA. Effect of lithotomy positions on strain of the obturator and lateral femoral cutaneous nerves. Clin Anat. 2004 Jan;17(1):45-9. doi: 10.1002/ca.10168.
- Background: PubMed 12271555Power H. Patient positioning outcomes for women undergoing gynaecological surgeries. Can Oper Room Nurs J. 2002 Sep;20(3):7-10, 27-30.
- Background: PubMed 27319365Sung VW, Wohlrab KJ, Madsen A, Raker C. Patient-reported goal attainment and comprehensive functioning outcomes after surgery compared with pessary for pelvic organ prolapse. Am J Obstet Gynecol. 2016 Nov;215(5):659.e1-659.e7. doi: 10.1016/j.ajog.2016.06.013. Epub 2016 Jun 16.
- Derived from this study: PubMed 32649498Gupta A, Meriwether K, Tuller M, Sekula M, Gaskins J, Stewart JR, Hobson D, Cardenas-Trowers O, Francis S. Candy Cane Compared With Boot Stirrups in Vaginal Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2020 Aug;136(2):333-341. doi: 10.1097/AOG.0000000000003954.
- Individual participant dataSharing planned: No
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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.
Sean L Francis, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal Surgery in people with Physical Activity and Surgery, run by University of Louisville at 1 site in United States.
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 3 inclusion and 9 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 9 Jun 2020. 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 United States. 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?
Change in Patient-Reported Outcomes Measurement and Information System(PROMIS) Physical Function Scale (time frame: preop and 6 weeks post op). 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 NCT03446950, which also lists 8 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 9 Jun 2020.