Clinical trial NCT03820115: Elastic Abdominal Binder After Open Abdominal Surgery for Benign Gynecologic Conditions
Official title: Effect of Elastic Abdominal Binder on Pain and Functional Recovery After Open Abdominal Surgery for Benign Gynecologic Conditions: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Disease
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2019-01-29
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: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Women, diagnosed with benign gynecologic conditions, undergoing open abdominal surgery

Exclusion Criteria:

* Surgeries performed for cancer
* Intraoperative accidental injury to urinary or gastrointestinal organs
* Postoperative admission to intensive care unit (ICU)
* Postoperative intraperitoneal drain placement
* Unable to understand and follow oral/written instructions
* Severe neuromuscular or circulatory disorders

Primary outcomes:
measure: Daily average postoperative pain scores
timeFrame: An average of pain scores at 8:00 am and 4:00 pm, up to 7 days postoperation
measure: Six-minute walk test score change from baseline
timeFrame: One day before operation and postoperative day 3
Secondary outcomes:
measure: Rate of postoperative complications
timeFrame: In the morning, up to 7 days postoperation
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Kittipat Charoenkwan
Study officials:
affiliation: Chiang Mai University
name: Kittipat Charoenkwan, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: