Study Investigating Role of Unalike Patient Positioning on PROMIS Scores

NCT03446950 | Completed

• 1 other identifier: 18.0061
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Physical Activity; Surgery; Vaginal Hysterectomy; Vaginal Surgery

Keywords

vaginal surgery; patient position; stirrups; functional status; urogynecology

Outcome Measures

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.

  preop and 6 weeks post op

Secondary Outcomes (1)

• Angles of positioning

  Intra-operative

Study Arms (2)

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.

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.

Procedure: Vaginal Surgery

Interventions

Vaginal Surgery PROCEDURE

Patients will undergo elective surgery on vagina or bladder

Boot Stirrups; Candy Cane

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville Physicians

Louisville, Kentucky, 40205, United States

Location

Related Publications (8)

• 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.

  PMID: 26365999 BACKGROUND

• 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.

  PMID: 19761997 BACKGROUND

• 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.

  PMID: 12088195 BACKGROUND

• 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.

  PMID: 12151144 BACKGROUND

• 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.

  PMID: 14695587 BACKGROUND

• Power H. Patient positioning outcomes for women undergoing gynaecological surgeries. Can Oper Room Nurs J. 2002 Sep;20(3):7-10, 27-30.

  PMID: 12271555 BACKGROUND

• 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.

  PMID: 27319365 BACKGROUND

• 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.

  PMID: 32649498 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Sean L Francis, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to their intervention group. Investigators following up with participants at 6 weeks will be blinded to the group allocation of the participants
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairperson & Assoc Professor

Model Details: 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

Study Record Dates

• First Submitted: February 11, 2018
• First Posted: February 27, 2018
• Study Start: March 6, 2018
• Primary Completion: November 22, 2019
• Study Completion: May 4, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)