Effect of Abdominal Binder After Laparoscopic Cholecystectomy on Enhanced Recovery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Laparoscopy

Intervention / Treatment
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* Device: abdomen binder (Sejung Korea, Seoul, Republic of Korea)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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)<br>* abdomen binder with a standard height of 22 cm (Sejung Korea, Seoul, Republic of Korea)<br>|
| No Intervention: Control group<br>subjects allocated in the control group, subjects were not given any opportunity to ware an abdominal binder. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | 12 hours after surgery | 
| postoperative pain | Subjects rated postoperative pain intensity using a visual analog scale (0-10, VAS) at 24 hours after surgery | 24 hours after surgery | 
| postoperative pain | Subjects rated postoperative pain intensity using a visual analog scale (0-10, VAS) at 48 hours after surgery | 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative hospital stay | Postoperative hospital stay days to discharge | Until dischage, an average of 2.3 days |