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Effect of Abdominal Binder After Laparoscopic Cholecystectomy on Enhanced Recovery

K

Kangbuk Samsung Hospital

Status

Completed

Conditions

Laparoscopy

Treatments

Device: abdomen binder (Sejung Korea, Seoul, Republic of Korea)

Study type

Interventional

Funder types

Other

Identifiers

NCT04787458
202002041

Details and patient eligibility

About

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.

Full 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.

Enrollment

65 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 18-65 years old
  • American Society of Anesthesiologists Physical Status classification I and II

Exclusion criteria

  • history of ventral hernia
  • walking disability
  • chronic obstructive respiratory disease
  • malignancy
  • chronic pain syndrome
  • open conversion
  • inability to complete the questionnaire

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

65 participants in 2 patient groups

Experimental group
Experimental group
Description:
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.
Treatment:
Device: abdomen binder (Sejung Korea, Seoul, Republic of Korea)
Control group
No Intervention group
Description:
subjects allocated in the control group, subjects were not given any opportunity to ware an abdominal binder.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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