Post-operative MilestonesABSNCT04414384
Abdominal Binder and Steps Trial
A study testing Abdominal Binder and Step Counter in people with Post-operative Milestones, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-operative Milestones
- What is being tested?
- Abdominal Binder and Step Counter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2020to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- English-speaking
- Female
- Patients undergoing benign hysterectomy or myomectomy via low-transverse laparotomy.
Who cannot join
- ASA classification of three or higher
- Malignancy
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Abdominal Binder and Steps (ABS): A Way to Improve Ambulation Post-Laparotomy in Benign GYN Surgery
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.
Read the detailed description
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.
- Conditions
- Post-operative Milestones
- Being tested
- Abdominal Binder, Step Counter
- Keywords
- Post-operative ambulation, Post-operative pain, Abdominal binder, Step counter
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal BinderOther
Abdominal Binder placement
Step CounterOther
step counter to track steps
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Binder | Experimental | During this time they will wear a step counter and track their steps. This step counter will be returned at the time of their two week visit. Receives: Other: Abdominal Binder; Other: Step Counter |
| Control | Other | This group of patients will not wear abdominal binders, but during this time they will wear a step counter and track their steps. This step counter will be returned at the time of their two week visit. Receives: Other: Step Counter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily step counts
Daily step counts taken via electronic step counter over the course of two weeks.
Measured: Two weeks (until post-operative appointment when step counter is returned)
Secondary outcomes (4)
Time to Ambulation
Time it takes for patient to begin ambulating post-operatively.
Measured: Within 24 hours (post-operative day one)
Narcotic utilization
Quantitative narcotic utilization while inpatient.
Measured: 24-48 hours post-operatively (the typical time from surgery to discharge)
Visual analogue pain scale
Patient's average pain scale as reported to nursing via analogue pain scale. Total scale from 0-10, higher score indicates more pain
Measured: 24-48 hours post-operatively (the typical time from surgery to discharge)
Number of participants who thinks there was a benefit
Number of participants who thinks they benefitted from wearing the abdominal binder as reported retrospectively at the two week post-operative visit.
Measured: Two weeks (at time of post-operative visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start28 Jun 2020
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative MilestonesStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomized to either the investigational group (abdominal binder) or control group (no abdominal binder). Those two groups are then both given step counters and their steps are recorded over a two week period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Ascher-Walsh, Icahn School of Medicine at Mount Sinai
- Investigators
- Charles Ascher-Walsh, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414384
- Sponsor's protocol ID
- GCO 19-2072
- Acronym
- ABS
- Status last verified
- Aug 2024
- First submitted
- 1 Jun 2020
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Binder and Steps (ABS): A Way to Improve Ambulation Post-Laparotomy in Benign GYN Surgery
- ClinicalTrials.gov ID
- NCT04414384
- Acronym / sponsor ID
- ABS / GCO 19-2072
- Conditions
- Post-operative Milestones
- Keywords
- Post-operative ambulation, Post-operative pain, Abdominal binder, Step counter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 28 Jun 2020 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are randomized to either the investigational group (abdominal binder) or control group (no abdominal binder). Those two groups are then both given step counters and their steps are recorded over a two week period.
| Arm | Type | Receives |
|---|---|---|
| Abdominal Binder | Experimental | Other: Abdominal Binder, Other: Step CounterDuring this time they will wear a step counter and track their steps. This step counter will be returned at the time of their two week visit. |
| Control | Other | Other: Step CounterThis group of patients will not wear abdominal binders, but during this time they will wear a step counter and track their steps. This step counter will be returned at the time of their two week visit. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- English-speaking
- Female
- Patients undergoing benign hysterectomy or myomectomy via low-transverse laparotomy.
Key exclusion criteria (3 listed)
- ASA classification of three or higher
- Malignancy
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal BinderAbdominal Binder placement | Other | Abdominal Binder |
| Step Counterstep counter to track steps | Other | Abdominal Binder, Control |
Primary outcome
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.
4 secondary outcomes
Time to Ambulation
Time frame: Within 24 hours (post-operative day one)
Narcotic utilization
Time frame: 24-48 hours post-operatively (the typical time from surgery to discharge)
Visual analogue pain scale
Time frame: 24-48 hours post-operatively (the typical time from surgery to discharge)
Number of participants who thinks there was a benefit
Time frame: Two weeks (at time of post-operative visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Ascher-Walsh, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Binder and Step Counter in people with Post-operative Milestones, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily step counts (time frame: Two weeks (until post-operative appointment when step counter is returned)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.