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

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.

Study Overview

• Status: Completed
• Conditions: Gynecologic Disease
• Intervention / Treatment: Device: Elastic abdominal binder

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Chiang Mai, Thailand, 50200
    • Kittipat Charoenkwan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Elastic abdominal binder	Device: Elastic abdominal binder; Each 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.
NO_INTERVENTION: No binder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily average postoperative pain scores	The participants are asked to rate postoperative pain according to 10-cm visual analog scales from '0' (no pain) to '10' (worst possible pain).	An average of pain scores at 8:00 am and 4:00 pm, up to 7 days postoperation
Six-minute walk test score change from baseline	Six-minute walk test (6MWT)	One day before operation and postoperative day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of postoperative complications	The complications of interest include febrile morbidity, wound complication, bowel ileus	In the morning, up to 7 days postoperation

Collaborators and Investigators

• Sponsor: Chiang Mai University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2018
• Primary Completion (ACTUAL): May 31, 2019
• Study Completion (ACTUAL): May 31, 2019

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (ACTUAL): January 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: OBG-2561-05421

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No