NCT03836365: PREOP

Patient Preparedness for Pelvic Organ Prolapse Surgery

Completed NA Last updated 4 June 2020

What this trial tests

NA trial testing Preoperative counseling office visit in Pelvic Organ Prolapse in 120 participants. Completed in 1 May 2020.

Timeline

2 April 2019

Primary endpoint
1 May 2020

1 May 2020

Quick facts

Lead sponsor	University of Pittsburgh
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	120
Start date	2 April 2019
Primary completion	1 May 2020
Estimated completion	1 May 2020
Sites	1 location across United States

Drugs / interventions tested

• Preoperative counseling office visit
• Preoperative counseling phone call

Conditions studied

• Pelvic Organ Prolapse — all drugs for Pelvic Organ Prolapse →
• Patient Preparedness — all drugs for Patient Preparedness →

Sponsor

University of Pittsburgh

Who can join

Adults 21 to 99, female only, with Pelvic Organ Prolapse or Patient Preparedness. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Patient Preparedness for Pelvic Organ Prolapse Surgery: A Randomized Equivalence Trial of Preoperative Counseling.
   Sassani JC, Grosse PJ, Kunkle L, Baranski L, et al · · 2021 · cited 13× · PMID 33787563 · DOI 10.1097/spv.0000000000001049
2. Preoperative Counseling Method and Postoperative Opioid Usage: A Secondary Analysis of the PREOP Study.
   Sassani JC, Artsen AM, Grosse PJ, Baranski L, et al · · 2021 · cited 4× · PMID 33620901 · DOI 10.1097/spv.0000000000001010