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The Effect of Abdominal Binder Use on Postoperative Pain and Mobility in Patients Undergoing Pelvic Surgery

Primary Purpose

Pelvic Organ Prolapse, Abdominal Surgery, Laparoscopic Surgery

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Abdominal binder
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Sites / Locations

  • University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control / No Binder

Abdominal binder

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To Assess Whether Post Operative Abdominal Binder Usage Shortens the Time to First Ambulation After Surgery.
Difference in the first time of ambulation after surgery during inpatient admission between non-abdominal binder patients and abdominal binder patients.
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.
Difference in VAS pain scores will be obtained only while the patient is admitted to the hospital post operatively between non-abdominal binder patients and abdominal binder patients.

Full Information

First Posted
April 24, 2018
Last Updated
April 13, 2022
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03684304
Brief Title
The Effect of Abdominal Binder Use on Postoperative Pain and Mobility in Patients Undergoing Pelvic Surgery
Official Title
The Effect of Abdominal Binder Use on Postoperative Pain and Mobility in Patients Undergoing Pelvic Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Patients no longer staying overnight in the hospital following this procedure type.
Study Start Date
October 30, 2017 (Actual)
Primary Completion Date
March 22, 2021 (Actual)
Study Completion Date
March 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, Abdominal Surgery, Laparoscopic Surgery, Post Operative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control / No Binder
Arm Type
No Intervention
Arm Description
Patients randomized to routine care / no abdominal binder use will not use an abdominal binder during their post operative course.
Arm Title
Abdominal binder
Arm Type
Experimental
Arm Description
Patients randomized abdominal binder use will have an abdominal binder placed on them in the operating room once their surgery has been completed.
Intervention Type
Device
Intervention Name(s)
Abdominal binder
Intervention Description
The abdominal binder is an elastic abdominal compression / support device that will be placed on the patient after surgery has been completed.
Primary Outcome Measure Information:
Title
To Assess Effect of Abdominal Binder on Total Post-operative Narcotic Use Within Seven Days Following Pelvic Surgery
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
To Assess Whether Post Operative Abdominal Binder Usage Shortens the Time to First Ambulation After Surgery.
Description
Difference in the first time of ambulation after surgery during inpatient admission between non-abdominal binder patients and abdominal binder patients.
Time Frame
1 day
Title
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.
Description
Difference in VAS pain scores will be obtained only while the patient is admitted to the hospital post operatively between non-abdominal binder patients and abdominal binder patients.
Time Frame
1 day

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Based on female biological sex due to requirement of pelvic surgery.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Facility Information:
Facility Name
University Hospitals
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Abdominal Binder Use on Postoperative Pain and Mobility in Patients Undergoing Pelvic Surgery

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