Effect of Abdominal Binder aftEr Laparoscopic Treatment on Postoperative Recovery

NCT03485859 | Completed

• 1 other identifier: 2018-03-039
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

There have been no studies exploring the efficacy of incision support using an elastic abdominal binder after laparoscopy to date. The investigators performed therefore a randomized controlled trial to determine the effect of post-laparoscopic abdominal binder use on enhanced recovery after surgery (ERAS) in patients with gynecologic disease.

Conditions

Laparoscopy

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  Subjects rated postoperative pain intensity using a visual analog scale (VAS) at 12, 24, and 48 hours after surgery. The scale was presented as a 10-cm line with verbal descriptors ranging from "no pain" to "worst imaginable pain".

  at 48 hours after surgery

Secondary Outcomes (2)

• limitation of walking ability

  at 48 hours after surgery

• Incentive spirometry performance

  at 24 hours after surgery

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. The binder was placed on the abdomen across the laparoscopic incision, with the upper border not higher than the lower margin of the rib cage, ensuring minimal restriction of lateral costal expansion and diaphragmatic excursion. 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: Experimental group

Control group

PLACEBO COMPARATOR

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

Device: Control group

Interventions

Experimental group DEVICE

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. The binder was placed on the abdomen across the laparoscopic incision, with the upper border not higher than the lower margin of the rib cage, ensuring minimal restriction of lateral costal expansion and diaphragmatic excursion. 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.

Experimental group

Control group DEVICE

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

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 65 years
• American Society of Anesthesiologists physical status (ASAPS) classification I-II
• absence of pregnancy at the time of surgery

You may not qualify if:

• body mass index (BMI) ≥30 kg/m2
• history of abdominal surgery within 6 months
• history of ventral or incisional hernia
• walking disabilities (or walking with the assistance of crutches or a walker)
• chronic obstructive respiratory disease
• stage IV cancer,
• chronic pain syndrome (defined as daily intake of opioids for chronic back pain, chronic headache, or fibromyalgia)
• inability to fill out the questionnaire

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, Jongno-gu, 03181, South Korea

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Taejong Song, MD PhD

  Kangbuk Samsung Hospital, Seoul, Republic of Korea

  PRINCIPAL INVESTIGATOR

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: Professor

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: April 2, 2018
• Study Start: April 20, 2018
• Primary Completion: August 5, 2018
• Study Completion: October 31, 2018
• Last Updated: April 3, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)