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Patient Preparedness for Pelvic Organ Prolapse Surgery

Patient Preparedness for Pelvic Organ Prolapse Surgery: A Randomized Controlled Trial of Preoperative Counseling

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03836365
Acronym
PREOP
Enrollment
120
Registered
2019-02-11
Start date
2019-04-02
Completion date
2020-05-01
Last updated
2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Preparedness, Pelvic Organ Prolapse

Keywords

Pelvic organ prolapse, Patient preparedness, Randomized controlled trial

Brief summary

Patient preparedness has been associated with increased patient satisfaction, decreased postoperative pain and decreased postoperative narcotic use; however, little is known regarding the optimal way to prepare patients prior to pelvic reconstructive surgery. The primary aim of this study is to determine if a preoperative counseling in person visit has similar rates of patient preparedness as a preoperative counseling phone call for women undergoing same-day pelvic organ prolapse surgery. Secondary aims evaluate patient satisfaction, postoperative pain scores and postoperative narcotic usage. Women who plan to undergo pelvic organ prolapse surgery will be randomized to a preoperative in person counseling visit or a preoperative counseling phone call. Participants will complete questionnaires to assess their preparedness, satisfaction and postoperative pain. The goal of this study is to gather information that will allow clinicians to improve patient surgical preparedness and satisfaction.

Detailed description

This will be a randomized controlled trial to assess patient preparedness following a preoperative counseling in person visit when compared to a preoperative counseling phone call. Recruitment & Enrollment: Participants will be recruited and enrolled from the urogynecology office during their surgical planning visit. The study will be introduced at this visit and participants will have the opportunity to bring the consent home to review and consider their participation prior to signing. Randomization: Participants will be block randomized in a 1:1 ratio in block size of 2. Randomization will be done by REDCap. The participant will not be blinded given the nature of the intervention. Additionally, the attending surgeon, fellow and office staff (advanced practice providers, research staff, medical assistants) will be aware of the randomization group as they will be participating in the preoperative intervention or perioperative clinical care. Intervention: Both the preoperative counseling visit and preoperative phone call will contain the same components of discussion and counseling which include surgical details, risks and benefits, preoperative and postoperative instructions and expectations. The visit will take place in the urogynecology office and the visits and phone calls will be done by either a fellow or advanced practice provider, all of whom have extensive experience with the standardized preoperative visit. Follow up: A postoperative phone call will be completed either POD#1 or POD#2 to remind the participant to complete their daily pain diary. Each participant will follow up for their standard postoperative visit approximately 4-6 weeks postoperative. All patients routinely receive a call on POD#1 from our nurses to assess how they are doing postoperatively. This phone call will continue unchanged for all participants.

Interventions

OTHERPreoperative counseling office visit

All patients undergo a preoperative counseling session prior to surgery. Participants in this arm will have an in person preoperative counseling office visit.

OTHERPreoperative counseling phone call

All patients undergo a preoperative counseling session prior to surgery. Participants in this arm will have a preoperative counseling phone call.

Sponsors

University of Pittsburgh Medical Center
CollaboratorOTHER
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Women planning to undergo same-day surgery to correct pelvic organ prolapse by the University of Pittsburgh Division of Urogynecology. Women remain eligible if they are admitted for observation following their surgery.

Exclusion criteria

* Non-English speaking patients * A preoperative exam requirement that would necessitate an in person office visit (i.e. need for pessary removal, self-catheterization teaching) * Plan for concomitant surgical management with gynecology oncology or colorectal surgery * Residence in a nursing home

Design outcomes

Primary

MeasureTime frameDescription
Patient preparednessAt postoperative visit (about 4-6 weeks after surgery)The percent of patients reporting preparedness on Preoperative Preparedness Questionnaire. Participants who answer strongly agree or agree to the statement Overall, I felt prepared for my surgery will be considered prepared. This instrument is a 9-item questionnaire and scored on a 5-point Likert scale with answers ranging from 5=strongly disagree to 1=strongly agree with 3=neutral. Therefore, scores of 1=strongly agree or 2=agree will be considered a positive answer for preparedness. It was adopted from a study by Kenton et al in 2007.

Secondary

MeasureTime frameDescription
Patient satisfaction: Decision Scale-Pelvic Floor Disorders questionnaireAt postoperative visit (about 4-6 weeks after surgery)The percent of patients reporting satisfaction on the Satisfaction with Decision Scale-Pelvic Floor Disorders questionnaire. This is a validated, 5-item questionnaire with answers on a 5-point likert scale with 1=strongly agree, 3=neutral and 5=strongly disagree. Answers of 1=strongly agree or 2=agree to the statement I am satisfied with my decision will be considered satisfied.
Postoperative pain scoresPostoperative days #1-7Postoperative pain scores on postoperative days #1-7 on a scale of 0-10. Participants will complete a daily pain diary which will assess their pain score with 0=no pain and 10=worst pain imaginable.
Postoperative narcotic usePostoperative days #1-7Postoperative narcotics used which will be assessed by the daily pain diary (question: How many narcotic pills did you use today? with the answer being the number of pills used that day).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026