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

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopy
• Intervention / Treatment: Device: abdomen binder (Sejung Korea, Seoul, Republic of Korea)

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Kangbuk Samsung Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental group; 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); abdomen binder with a standard height of 22 cm (Sejung Korea, Seoul, Republic of Korea)
NO_INTERVENTION: Control group; subjects allocated in the control group, subjects were not given any opportunity to ware an abdominal binder.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kangbuk Samsung Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 9, 2020
• Primary Completion (ACTUAL): December 20, 2020
• Study Completion (ACTUAL): February 10, 2021

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (ACTUAL): March 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 8, 2021
• Last Update Submitted That Met QC Criteria: March 5, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 202002041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No