Effect of Abdominal Binder After Laparoscopic Cholecystectomy on Enhanced Recovery

Laparoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04787458
• Other study ID #: 202002041
• Status: Completed
• Phase: N/A
• Start date: August 9, 2020
• Est. completion date: February 10, 2021

Study information

• Verified date: March 2021
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 10, 2021
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopy

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Kangbuk Samsung Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	postoperative pain	Subjects rated postoperative pain intensity using a visual analog scale (0-10, VAS) at 12 hours after surgery	12 hours after surgery
Primary	postoperative pain	Subjects rated postoperative pain intensity using a visual analog scale (0-10, VAS) at 24 hours after surgery	24 hours after surgery
Primary	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	Postoperative hospital stay	Postoperative hospital stay days to discharge	Until dischage, an average of 2.3 days