NCT03820115

Elastic Abdominal Binder After Open Abdominal Surgery for Benign Gynecologic Conditions

Completed NA Last updated 5 February 2020

What this trial tests

NA trial testing Elastic abdominal binder in Gynecologic Disease in 66 participants. Completed in 31 May 2019.

Timeline

1 October 2018

Primary endpoint
31 May 2019

31 May 2019

Quick facts

Lead sponsor	Chiang Mai University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	66
Start date	1 October 2018
Primary completion	31 May 2019
Estimated completion	31 May 2019
Sites	1 location across Thailand

Drugs / interventions tested

• Elastic abdominal binder

Conditions studied

• Gynecologic Disease — all drugs for Gynecologic Disease →

Sponsor

Chiang Mai University

Who can join

Adults 18 to 65, female only, with Gynecologic Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Surgery remains the backbone of modern management of benign gynecologic conditions. Some common surgical procedures include hysterectomy for uterine leiomyoma or adenomyosis, adnexectomy for ovarian and tubal pathology, and other conservative surgeries. These procedures can be accomplished by different surgical approaches comprising abdominal, vaginal, and laparoscopic routes. Although the use of vaginal and laparoscopic approach has increased in recent years, the open abdominal route is still the most commonly employed approach. This is especially the case in developing countries where resources to support the more expensive approach such as laparoscopy are quite limited. However, the procedure can be associated with significant morbidity. Delayed functional recovery influenced by pain and immobilization are important contributing factors for increased morbidity. Elastic abdominal binder, a wide elastic belt that is wore around the patient's abdomen to support surgical incision after surgery, has been employed by clinicians for pain relief, wound complications prevention, improved pulmonary function, and stabilization. Benefits of the abdominal binder use in this patient population have not been properly examined.

The aim of this study is to examine the effect of postoperative elastic abdominal binder use on recovery by comparing pain scores and mobility function (through the 6-minute walk test \[6MWT\]) in postoperative gynecologic patients who use versus do not use the elastic abdominal binder to support incisional site.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.