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Completed

NCT Number: NCT03485859

Effect of Abdominal Binder aftEr Laparoscopic Treatment on Postoperative Recovery

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.

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Key information

Conditions

Laparoscopy

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kangbuk Samsung Hospital

Seoul, Jongno-gu, 03181, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Control group

Device

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Kangbuk Samsung Hospital

Other

Registry information

Official study title

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

Acronym: BELT

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 2, 2018
Registry last updated
Apr 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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