Effect of Abdominal Binder After Laparoscopic Cholecystectomy on Enhanced Recovery

Not Applicable

Completed

• Conditions: Laparoscopy
• Interventions: Device: abdomen binder (Sejung Korea, Seoul, Republic of Korea)

• Registration Number: NCT04787458
• Lead Sponsor: Kangbuk Samsung Hospital

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.

Study Timeline

• Study Start: 2020-08-09
• Primary Completion: 2020-12-20
• Study First Submitted: 2021-02-09
• Study Completion: 2021-02-10
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-05
• Last Update Submitted: 2021-03-05
• Study First Posted: 2021-03-08
• Last Update Posted: 2021-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	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.

Primary Outcome Measures

Name	Time	Method
degree of comfort	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	48 hours after surgery	Subjects rated postoperative pain intensity using a visual analog scale (0-10, VAS) at 48 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Postoperative hospital stay	Until dischage, an average of 2.3 days	Postoperative hospital stay days to discharge

Trial Locations

Locations (1)

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of