Effect of Abdominal Binder After Laparoscopic Cholecystectomy on Enhanced Recovery

NCT ID: NCT04787458

Last Updated: 2021-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-09
• Study Completion Date: 2021-02-10

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.

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.

Conditions

Laparoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kangbuk Samsung Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sung Ryol Lee

Hepato-biliary and pancreatic department of General Surgery, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kangbuk Samsung Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

202002041

Identifier Type: -

Identifier Source: org_study_id