Clinical Trials Directory

Trials / Completed

CompletedNCT03820115

Elastic Abdominal Binder After Open Abdominal Surgery for Benign Gynecologic Conditions

Effect of Elastic Abdominal Binder on Pain and Functional Recovery After Open Abdominal Surgery for Benign Gynecologic Conditions: a Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
66 (actual)
Sponsor
Chiang Mai University · Academic / Other
Sex
Female
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DEVICEElastic abdominal binderEach woman in the intervention group is fitted with an elastic abdominal binder at the time of procedure completion just before leaving the operating room. The binder is placed snuggly tight (keeping in mind patient's comfort) on top of the hospital gown with the incision positioned at the middle part of the binder. The patients are encouraged to wear binders at all time. However, periods of break from wearing the binder are allowed at their convenience.

Timeline

Start date
2018-10-01
Primary completion
2019-05-31
Completion
2019-05-31
First posted
2019-01-29
Last updated
2020-02-05

Locations

1 site across 1 country: Thailand

Source: ClinicalTrials.gov record NCT03820115. Inclusion in this directory is not an endorsement.