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OpenTrials
Completed

NCT Number: NCT04414384

Abdominal Binder and Steps Trial

Large lower abdominal incisions are still used in many types of common gynecologic surgeries. Patients may experience pain and restrictions to ambulation because of this, which can make healing after surgery harder and more complicated. Abdominal binders, through their added abdominal support, may provide a low cost intervention to help people heal. The study team aims to investigate the effects of abdominal binders on walking in the post- gynecologic surgery period.

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Key information

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

New York, 10128, United States

About this study

Laparotomy is a commonly utilized modality for abdominal entry in benign gynecologic surgery despite preference for minimally invasive techniques when surgically feasible. As with other major abdominal surgeries, patients may experience pain and restrictions to ambulation related to the abdominal incision that complicate the postoperative period. Abdominal binders, through their added abdominal support, may provide a low cost, noninvasive intervention to enhance this vital recovery period. Though the use of abdominal binders have been studied extensively in the postcesarean section patient, no report to date exists assessing the effects on abdominal binders in the postoperative course of benign gynecologic surgeries. The study team aims to investigate the effects of abdominal binders on ambulation in the postoperative period after laparotomy for benign gynecologic surgery. The primary outcome is quantitative ambulation via electronic step counter. Secondary outcomes include time to ambulation, quantitative narcotic utilization, visual analogue pain scale, subjective overall wellbeing. With 85% power the study team attempts to calculate a 1200 step difference in means between abdominal binder and control groups using 67 patients per study arm.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English-speaking
  • Female
  • Patients undergoing benign hysterectomy or myomectomy via low-transverse laparotomy.

Exclusion criteria

  • ASA classification of three or higher
  • Malignancy
  • Non-English speaking

Treatment and study plan

Abdominal binder

Other

Abdominal Binder placement

Step Counter

Other

step counter to track steps

Primary outcomes

  1. Daily step counts

    Time frame: Two weeks (until post-operative appointment when step counter is returned)

    Daily step counts taken via electronic step counter over the course of two weeks.

Secondary outcomes

  1. Time to Ambulation

    Time frame: Within 24 hours (post-operative day one)

    Time it takes for patient to begin ambulating post-operatively.

  2. Narcotic utilization

    Time frame: 24-48 hours post-operatively (the typical time from surgery to discharge)

    Quantitative narcotic utilization while inpatient.

  3. Visual analogue pain scale

    Time frame: 24-48 hours post-operatively (the typical time from surgery to discharge)

    Patient's average pain scale as reported to nursing via analogue pain scale. Total scale from 0-10, higher score indicates more pain

  4. Number of participants who thinks there was a benefit

    Time frame: Two weeks (at time of post-operative visit)

    Number of participants who thinks they benefitted from wearing the abdominal binder as reported retrospectively at the two week post-operative visit.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Abdominal Binder and Steps (ABS): A Way to Improve Ambulation Post-Laparotomy in Benign GYN Surgery

Acronym: ABS

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 4, 2020
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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