Clinical trial NCT03485859: Effect of Abdominal Binder aftEr Laparoscopic Treatment on Postoperative Recovery
Official title: Effect of Abdominal Binder aftEr Laparoscopic Treatment on Postoperative Recovery (BELT): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopy
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: postoperative pain
timeFrame: at 48 hours after surgery
Secondary outcomes:
measure: limitation of walking ability
timeFrame: at 48 hours after surgery
measure: Incentive spirometry performance
timeFrame: at 24 hours after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
state: Jongno-gu
Study officials:
affiliation: Kangbuk Samsung Hospital, Seoul, Republic of Korea
name: Taejong Song, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: