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Effect of Abdominal Binder After Laparoscopic Cholecystectomy on Enhanced Recovery

Effect of Abdominal Binder After Laparoscopic Cholecystectomy on Enhanced Recovery(ABC) : a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04787458
Enrollment
65
Registered
2021-03-08
Start date
2020-08-09
Completion date
2021-02-10
Last updated
2021-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopy

Brief 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. 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.

Interventions

DEVICEabdomen binder (Sejung Korea, Seoul, Republic of Korea)

abdomen binder with a standard height of 22 cm (Sejung Korea, Seoul, Republic of Korea)

Sponsors

Kangbuk Samsung Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
degree of comfortUntil dischage, an average of 2.5 daysQuestionnaire response options ranged from very comfortable (5) to very Questionnaire response options ranged from very comfortable (5) to very uncomfortable (0).
postoperative pain12 hours after surgerySubjects rated postoperative pain intensity using a visual analog scale (0-10, VAS) at 12 hours after surgery

Secondary

MeasureTime frameDescription
Postoperative hospital stayUntil dischage, an average of 2.3 daysPostoperative hospital stay days to discharge

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026