Effect of Abdominal Binder After Laparoscopic Cholecystectomy on Enhanced Recovery

Overview

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.

Full Title of Study: “Effect of Abdominal Binder After Laparoscopic Cholecystectomy on Enhanced Recovery(ABC) : a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 20, 2020

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

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

Arms, Groups and Cohorts

  • 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.
  • No Intervention: Control group
    • subjects allocated in the control group, subjects were not given any opportunity to ware an abdominal binder.

Clinical Trial Outcome Measures

Primary Measures

  • degree of comfort
    • Time Frame: 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
    • Time Frame: 12 hours after surgery
    • Subjects rated postoperative pain intensity using a visual analog scale (0-10, VAS) at 12 hours after surgery
  • postoperative pain
    • Time Frame: 24 hours after surgery
    • Subjects rated postoperative pain intensity using a visual analog scale (0-10, VAS) at 24 hours after surgery
  • postoperative pain
    • Time Frame: 48 hours after surgery
    • Subjects rated postoperative pain intensity using a visual analog scale (0-10, VAS) at 48 hours after surgery

Secondary Measures

  • Postoperative hospital stay
    • Time Frame: Until dischage, an average of 2.3 days
    • Postoperative hospital stay days to discharge

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Kangbuk Samsung Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sung Ryol Lee, Hepato-biliary and pancreatic department of General Surgery, Assistant Professor – Kangbuk Samsung Hospital

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