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

NCT ID: NCT03684304

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-30
• Study Completion Date: 2021-03-22

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.

Conditions

Pelvic Organ Prolapse; Abdominal Surgery; Laparoscopic Surgery; Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control / No Binder

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Abdominal binder

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

Group Type: EXPERIMENTAL

Abdominal binder

Intervention Type: DEVICE

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

Interventions

Abdominal binder

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

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Caitlin Carlton

Resident Physician, Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospitals

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

binder071718

Identifier Type: -

Identifier Source: org_study_id