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

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ClinicalTrials.gov Identifier: NCT03485859
Recruitment Status : Completed
First Posted : April 2, 2018
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Taejong Song, Kangbuk Samsung Hospital

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.

Condition or disease Intervention/treatment Phase
Laparoscopy Device: Experimental group Device: Control group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Abdominal Binder aftEr Laparoscopic Treatment on Postoperative Recovery (BELT): a Randomized Controlled Trial
Actual Study Start Date : April 20, 2018
Actual Primary Completion Date : August 5, 2018
Actual Study Completion Date : October 31, 2018

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.




Primary Outcome Measures :
  1. postoperative pain [ Time Frame: at 48 hours after surgery ]
    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".


Secondary Outcome Measures :
  1. limitation of walking ability [ Time Frame: at 48 hours after surgery ]
    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.

  2. Incentive spirometry performance [ Time Frame: at 24 hours after surgery ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03485859


Locations
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Korea, Republic of
Kangbuk Samsung Hospital
Seoul, Jongno-gu, Korea, Republic of, 03181
Sponsors and Collaborators
Kangbuk Samsung Hospital
Investigators
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Principal Investigator: Taejong Song, MD PhD Kangbuk Samsung Hospital, Seoul, Republic of Korea
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Responsible Party: Taejong Song, Professor, Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier: NCT03485859    
Other Study ID Numbers: 2018-03-039
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No