LaparoscopyNCT04787458
Effect of Abdominal Binder After Laparoscopic Cholecystectomy on Enhanced Recovery
A study testing abdomen binder (Sejung Korea, Seoul, Republic of Korea) in people with Laparoscopy, run by Kangbuk Samsung Hospital at 1 site in South Korea.
Trial summary
There have been reports that abdominal binder use after laparoscopic or open surgery affects postoperative respiratory function, walking performance, and pain but no study has evaluated binder use solely for laparoscopic cholecystectomy surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopy
- What is being tested?
- abdomen binder (Sejung Korea, Seoul, Republic of Korea)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Aug 2020to 10 Feb 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years old
- American Society of Anesthesiologists Physical Status classification I and II
Who cannot join
- history of ventral hernia
- walking disability
- chronic obstructive respiratory disease
- malignancy
- chronic pain syndrome
- open conversion
- inability to complete the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Abdominal Binder After Laparoscopic Cholecystectomy on Enhanced Recovery(ABC) : a Randomized Controlled Trial
There have been reports that abdominal binder use after laparoscopic or open surgery affects postoperative respiratory function, walking performance, and pain but no study has evaluated binder use solely for laparoscopic cholecystectomy surgery. Therefore, the investigators performed a randomized controlled trial to evaluate the effect of abdominal binders after laparoscopic cholecystectomy by comparing postoperative outcomes in two patient groups.
Read the detailed description
Abdominal binders help to prevent postoperative complications, however, their use is controversial because of a lack of evidence for their effectiveness and because they also confer disadvantages. The purpose of this randomized controlled trial was to compare the effects of abdominal binder after laparoscopic cholecystectomy on pain, degree of comfort, time until ambulation, walking ability, return of bowel function, and diet resumption.
- Conditions
- Laparoscopy
- Being tested
- abdomen binder (Sejung Korea, Seoul, Republic of Korea)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdomen binder (Sejung Korea, Seoul, Republic of Korea)Device
abdomen binder with a standard height of 22 cm (Sejung Korea, Seoul, Republic of Korea)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | In subjects allocated to the abdominal binder group, the abdomen binder with a standard height of 22 cm (Sejung Korea, Seoul, Republic of Korea) was applied before leaving the operating room. Subjects were carefully instructed to use the abdominal binder during at least the first 2 consecutive days and night, and to reposition the abdominal binder correctly when needed. Receives: Device: abdomen binder (Sejung Korea, Seoul, Republic of Korea) |
| Control group | No intervention | subjects allocated in the control group, subjects were not given any opportunity to ware an abdominal binder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of comfort
Questionnaire response options ranged from very comfortable (5) to very Questionnaire response options ranged from very comfortable (5) to very uncomfortable (0).
Measured: Until dischage, an average of 2.5 days
postoperative pain
Subjects rated postoperative pain intensity using a visual analog scale (0-10, VAS) at 12 hours after surgery
Measured: 12 hours after surgery
postoperative pain
Subjects rated postoperative pain intensity using a visual analog scale (0-10, VAS) at 24 hours after surgery
Measured: 24 hours after surgery
postoperative pain
Subjects rated postoperative pain intensity using a visual analog scale (0-10, VAS) at 48 hours after surgery
Measured: 48 hours after surgery
Secondary outcomes (1)
Postoperative hospital stay
Postoperative hospital stay days to discharge
Measured: Until dischage, an average of 2.3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start9 Aug 2020
- Primary completion20 Dec 2020
- Study completion10 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparoscopyStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Ryol Lee, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787458
- Sponsor's protocol ID
- 202002041
- Status last verified
- Mar 2021
- First submitted
- 9 Feb 2021
- Last updated
- 8 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Abdominal Binder After Laparoscopic Cholecystectomy on Enhanced Recovery(ABC) : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04787458
- Acronym / sponsor ID
- 202002041
- Conditions
- Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- 9 Aug 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 8 Mar 2021 (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.
There have been reports that abdominal binder use after laparoscopic or open surgery affects postoperative respiratory function, walking performance, and pain but no study has evaluated binder use solely for laparoscopic cholecystectomy surgery. Therefore, the investigators performed a randomized controlled trial to evaluate the effect of abdominal binders after laparoscopic cholecystectomy by comparing postoperative outcomes in two patient groups.
Detailed description
Abdominal binders help to prevent postoperative complications, however, their use is controversial because of a lack of evidence for their effectiveness and because they also confer disadvantages. The purpose of this randomized controlled trial was to compare the effects of abdominal binder after laparoscopic cholecystectomy on pain, degree of comfort, time until ambulation, walking ability, return of bowel function, and diet resumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: abdomen binder (Sejung Korea, Seoul, Republic of Korea)In subjects allocated to the abdominal binder group, the abdomen binder with a standard height of 22 cm (Sejung Korea, Seoul, Republic of Korea) was applied before leaving the operating room. Subjects were carefully instructed to use the abdominal binder during at least the first 2 consecutive days and night, and to reposition the abdominal binder correctly when needed. |
| Control group | No intervention | –subjects allocated in the control group, subjects were not given any opportunity to ware an abdominal binder. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 years old
- American Society of Anesthesiologists Physical Status classification I and II
Key exclusion criteria (7 listed)
- history of ventral hernia
- walking disability
- chronic obstructive respiratory disease
- malignancy
- chronic pain syndrome
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 |
|---|---|---|
| abdomen binder (Sejung Korea, Seoul, Republic of Korea)abdomen binder with a standard height of 22 cm (Sejung Korea, Seoul, Republic of Korea) | Device | Experimental group |
Primary outcome
degree of comfort
Time frame: Until dischage, an average of 2.5 days
Questionnaire response options ranged from very comfortable (5) to very Questionnaire response options ranged from very comfortable (5) to very uncomfortable (0).
postoperative pain
Time frame: 12 hours after surgery
Subjects rated postoperative pain intensity using a visual analog scale (0-10, VAS) at 12 hours after surgery
postoperative pain
Time frame: 24 hours after surgery
Subjects rated postoperative pain intensity using a visual analog scale (0-10, VAS) at 24 hours after surgery
postoperative pain
Time frame: 48 hours after surgery
Subjects rated postoperative pain intensity using a visual analog scale (0-10, VAS) at 48 hours after surgery
1 secondary outcome
Postoperative hospital stay
Time frame: Until dischage, an average of 2.3 days
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 8 Mar 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing abdomen binder (Sejung Korea, Seoul, Republic of Korea) in people with Laparoscopy, run by Kangbuk Samsung Hospital at 1 site in South Korea.
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 2 inclusion and 7 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 8 Mar 2021. 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 South Korea. 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?
degree of comfort (time frame: Until dischage, an average of 2.5 days). The study lists 4 primary outcomes in all. 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 8 Mar 2021.