Effect of Abdominal Binder aftEr Laparoscopic Treatment on Postoperative Recovery

NCT ID: NCT03485859

Last Updated: 2019-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-20
• Study Completion Date: 2018-10-31

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.

Conditions

Laparoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Experimental group

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Control group

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Control group

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kangbuk Samsung Hospital

OTHER

Sponsor Role: lead

Responsible Party

Taejong Song

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Taejong Song, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Kangbuk Samsung Hospital, Seoul, Republic of Korea

Locations

Kangbuk Samsung Hospital

Seoul, Jongno-gu, South Korea

Countries

South Korea

Other Identifiers

2018-03-039

Identifier Type: -

Identifier Source: org_study_id