Effect of Abdominal Binder aftEr Laparoscopic Treatment on Postoperative Recovery (BELT)

Effect of Abdominal Binder aftEr Laparoscopic Treatment on Postoperative Recovery (BELT): a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopy
• Intervention / Treatment: Device: Experimental group; Device: Control group

Detailed Description

An abdominal elastic binder (girdles, trusses, abdominal belts, longuette, etc.) is a wide belt that surrounds the abdomen and supports the incision . Abdominal binder is routinely used after open surgery and Cesarean section, because it has been reported, according to a recent systematic review, to facilitate enhanced recovery after surgery (ERAS) such as pain relief, reduced risk of seroma formation, improved respiratory function, and assisted physical function using additional support to the lower abdominal musculature.

However, the routine use of abdominal binder after laparoscopy has been challenged due to a potential risk of postoperative pulmonary complications and deep venous thrombosis due to increased intra-abdominal pressure. Also, abdominal binders after laparoscopy have been criticized for being uncomfortable and hot to wear and for impinging the breast line in females. Therefore, some laparoscopists prefer the use of abdominal binder in patients undergoing laparoscopy, while other laparoscopists did not. However, 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 ERAS in patients with gynecologic disease.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 03181
      • Kangbuk Samsung Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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. 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; 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.
Placebo Comparator: Control group; In subjects allocated in the control group, subjects were not given any opportunity to ware an abdominal binder.	Device: Control group; In subjects allocated in the control group, subjects were not given any opportunity to ware an abdominal binder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
limitation of walking ability	Subjects were instructed to place a mark on a 10-cm line corresponding to the percentage of full-walking ability, with 0 cm representing no activity limitation and 10 cm being the maximal activity limitation.	at 48 hours after surgery
Incentive spirometry performance	Volumetric incentive spirometry (Hyupsung Medical Co., Ltd, Yangju, Republic of Korea) was performed in all subjects at 24 hours after surgery, because inspiratory spirometry can be used as a simple mean to follow lung volume, especially vital capacity and inspiratory reserve volume, in postoperative period in spontaneous breathing patients.	at 24 hours after surgery

Collaborators and Investigators

• Sponsor: Kangbuk Samsung Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2018
• Primary Completion (Actual): August 5, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: March 30, 2018
• First Posted (Actual): April 2, 2018

Study Record Updates

• Last Update Posted (Actual): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2018-03-039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No