An interventional study of abdomen binder (Sejung Korea, Seoul, Republic of Korea) in Laparoscopy, sponsored by Kangbuk Samsung Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-08.
Sponsored by Kangbuk Samsung Hospital · Not applicable, Interventional, and Treatment
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.
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.
Kangbuk Samsung Hospital is the lead sponsor of 59 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: abdomen binder (Sejung Korea, Seoul, Republic of Korea)
subjects allocated in the control group, subjects were not given any opportunity to ware an abdominal binder.
abdomen binder with a standard height of 22 cm (Sejung Korea, Seoul, Republic of Korea)
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).
Time frame: 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
Time frame: 12 hours after surgery
postoperative pain
Subjects rated postoperative pain intensity using a visual analog scale (0-10, VAS) at 24 hours after surgery
Time frame: 24 hours after surgery
postoperative pain
Subjects rated postoperative pain intensity using a visual analog scale (0-10, VAS) at 48 hours after surgery
Time frame: 48 hours after surgery
Postoperative hospital stay
Postoperative hospital stay days to discharge
Time frame: Until dischage, an average of 2.3 days
Plan to share: No
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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Kangbuk Samsung Hospital