Effect of Abdominal Binder After Laparoscopic Cholecystectomy on Enhanced Recovery

NCT04787458 | Completed

• 1 other identifier: 202002041
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Postoperative hospital stay

  Until dischage, an average of 2.3 days

Study Arms (2)

Experimental group

EXPERIMENTAL

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)

Control group

NO INTERVENTION

subjects allocated in the control group, subjects were not given any opportunity to ware an abdominal binder.

Interventions

abdomen binder (Sejung Korea, Seoul, Republic of Korea) DEVICE

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• American Society of Anesthesiologists Physical Status classification I and II

You may not qualify if:

• history of ventral hernia
• walking disability
• chronic obstructive respiratory disease
• malignancy
• chronic pain syndrome
• open conversion
• inability to complete the questionnaire

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hepato-biliary and pancreatic department of General Surgery, Assistant Professor

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: March 8, 2021
• Study Start: August 9, 2020
• Primary Completion: December 20, 2020
• Study Completion: February 10, 2021
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)