ClinicalTrials.gg
CompletedNCT03446950STIRUPPSUpdated Jun 9, 2020

Study Investigating Role of Unalike Patient Positioning on PROMIS Scores

An interventional study of Vaginal Surgery in Physical Activity, Surgery and Vaginal Hysterectomy, sponsored by University of Louisville. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-09.

Sponsored by University of Louisville · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
155
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 2,858 studies in Motor Activity with a site in United States — 423 open to participants now, 564 under way, 9 of them phase 3. Motor Activity · United States.

Enrollment
612th of 2,605
155 · median 55
Started
2018
with 169 others
No phase
2,243 of 2,858
353 open now
Registered
1,434th of 2,858
by date

Among the 2,858 studies in Motor Activity with a site in United States, this one is the 612th largest by enrollment of the 2,605 interventional ones that give a count, is one of 170 that started in 2018, is one of 2,243 with no phase, and was the 1,434th registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

423 of the 2,858 studies in Motor Activity with a site in United States are open now. Recruiting first, the newest first:

418 more — sign in →

All 423 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 18 Years and older · female · healthy volunteers too.

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02

Study 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 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
03

Conditions studied

  • Physical Activity
  • Surgery
  • Vaginal Hysterectomy
  • Vaginal Surgery

Browse trials for

Keywords

  • vaginal surgery
  • patient position
  • stirrups
  • functional status
  • urogynecology
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age > 18 years
  • English speaking
  • Scheduled to undergo vaginal or urological surgery with University of Louisville Urogynecology physicians

Exclusion criteria

Exclusion Criteria:

  • Immobile or wheelchair bound
  • Pre-existing neurological condition limiting physical function
  • Age \< 18 years
  • Patient's with dementia or unable to give
  • Non-English speaking
  • Unwilling to follow up in 6 weeks
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
155 participants (actual)

Study arms

  • Active comparator
    Candy Cane

    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.

    Procedure: Vaginal Surgery

  • Active comparator
    Boot Stirrups

    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.

    Procedure: Vaginal Surgery

Interventions

  • ProcedureVaginal Surgery

    Patients will undergo elective surgery on vagina or bladder

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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

    Time frame: Intra-operative

07

Study locations

1 site
  • University of Louisville Physicians
    Louisville, Kentucky 40205, United States
08

References and documents

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 26365999 ↗
  • Bohrer 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 19761997 ↗
  • Gumus 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 12088195 ↗
  • Cardosi 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 12151144 ↗
  • Litwiller 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 14695587 ↗
  • Power H. Patient positioning outcomes for women undergoing gynaecological surgeries. Can Oper Room Nurs J. 2002 Sep;20(3):7-10, 27-30. PubMed 12271555 ↗
  • Sung 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 27319365 ↗
  • Gupta 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Nov 2019, 20 months.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 20 months is above that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 11, 2018
First posted
Feb 27, 2018
StartActual
Mar 6, 2018
Primary completionActual
Nov 22, 2019
CompletionActual
May 4, 2020
Last update
Jun 9, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03446950
Responsible party
Sean Francis (Chairperson & Assoc Professor, University of Louisville) — Principal investigator
First posted
Feb 27, 2018
Start date
Mar 6, 2018
Primary completion
Nov 22, 2019
Completion
May 4, 2020
Last update
Jun 9, 2020

Study contacts

Sean L Francis, MD
principal investigator · University of Louisville

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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