NCT03684304

Brief Summary

To determine the effect of post-operative abdominal binder usage on total narcotic usage after undergoing surgery. To determine if abdominal binder usage results in decreased visual analog scale (VAS) pain scores and shorter time to first ambulation post operatively.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2021

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 11, 2022

Completed
Last Updated

May 11, 2022

Status Verified

April 1, 2022

Enrollment Period

3.4 years

First QC Date

April 24, 2018

Results QC Date

March 6, 2022

Last Update Submit

April 13, 2022

Conditions

Pelvic Organ ProlapseAbdominal SurgeryLaparoscopic SurgeryPost Operative Pain

Outcome Measures

Primary Outcomes (1)

  • To Assess Effect of Abdominal Binder on Total Post-operative Narcotic Use Within Seven Days Following Pelvic Surgery

    Total narcotic usage, calculated in morphine equivalents, during the first seven days post operatively to be calculated and a difference in the amount used by non-abdominal binder patients and abdominal binder patients will be determined. Will review medical record to determine amount of medication used while inpatient, amount / type of narcotic medication prescribed for discharge home, and will call patients to determine how many narcotic pills they have remaining on post operative day seven and calculate the amount used which will then be converted to morphine equivalents.

    7 days

Secondary Outcomes (2)

  • To Assess Whether Post Operative Abdominal Binder Usage Shortens the Time to First Ambulation After Surgery.

    1 day

  • To Compare Post Operative Pain Scores Using Visual Analog Scale (VAS) Scores in Post Operatives Patients Who Use and do Not Use an Abdominal Binder.

    1 day

Study Arms (2)

Control / No Binder

NO INTERVENTION

Patients randomized to routine care / no abdominal binder use will not use an abdominal binder during their post operative course.

Abdominal binder

EXPERIMENTAL

Patients randomized abdominal binder use will have an abdominal binder placed on them in the operating room once their surgery has been completed.

Device: Abdominal binder

Interventions

Abdominal binderDEVICE

The abdominal binder is an elastic abdominal compression / support device that will be placed on the patient after surgery has been completed.

Abdominal binder

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBased on female biological sex due to requirement of pelvic surgery.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must be 18 years or older.
  • Willing and able to provide informed consent.
  • Patients must be undergoing scheduled pelvic surgery.
  • Patients must be admitted overnight (at least one night) after surgery.

You may not qualify if:

  • Patients who are younger than 18 years old.
  • Patients who are unable or unwilling to provide informed consent.
  • Patients who are illiterate.
  • Patients who are non-English speaking or reading.
  • Patients who are unwilling to be contacted by phone after surgery.
  • Patients who are undergoing pelvic surgery that does not warrant observation or admission after surgery for at least one night.
  • Patients who are having surgery for any other indication other than pelvic surgery.
  • Patients with a chronic pain syndrome (as evidenced by daily intake of opioids).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Pelvic Organ ProlapsePain, Postoperative

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPainNeurologic ManifestationsSigns and Symptoms

Results Point of Contact

Title
University Hospitals
Organization
University Hospitals
info@uhhospitals.org
216-844-1000

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician, Primary Investigator

Study Record Dates

First Submitted

April 24, 2018

First Posted

September 25, 2018

Study Start

October 30, 2017

Primary Completion

March 22, 2021

Study Completion

March 22, 2021

Last Updated

May 11, 2022

Results First Posted

May 11, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)