Effect of Abdominal Binder aftEr Laparoscopic Treatment on Postoperative Recovery (BELT): a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Laparoscopy
- Sponsor
- Kangbuk Samsung Hospital
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- postoperative pain
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
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.
Investigators
Taejong Song
Professor
Kangbuk Samsung Hospital
Eligibility 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
Outcomes
Primary Outcomes
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
- Incentive spirometry performance(at 24 hours after surgery)
- limitation of walking ability(at 48 hours after surgery)