Elastic Abdominal Binder After Open Abdominal Surgery for Benign Gynecologic Conditions

• ClinicalTrials.gov Identifier: NCT03820115
• Recruitment Status: Completed
• First Posted: January 29, 2019
• Last Update Posted: February 5, 2020
• Sponsor: Chiang Mai University
• Information provided by (Responsible Party): Kittipat Charoenkwan, MD, Chiang Mai University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gynecologic Disease	Device: Elastic abdominal binder	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Effect of Elastic Abdominal Binder on Pain and Functional Recovery After Open Abdominal Surgery for Benign Gynecologic Conditions: a Randomized Controlled Trial
• Actual Study Start Date: October 1, 2018
• Actual Primary Completion Date: May 31, 2019
• Actual Study Completion Date: May 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Rate of postoperative complications [ Time Frame: In the morning, up to 7 days postoperation ]
   The complications of interest include febrile morbidity, wound complication, bowel ileus

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Thailand

Kittipat Charoenkwan

Chiang Mai, Thailand, 50200

Sponsors and Collaborators

Chiang Mai University

Investigators

• Principal Investigator: Kittipat Charoenkwan, MD, MSc; Chiang Mai University

More Information

• Responsible Party: Kittipat Charoenkwan, MD, Associate Professor, Chiang Mai University
• ClinicalTrials.gov Identifier: NCT03820115
• Other Study ID Numbers: OBG-2561-05421
• First Posted: January 29, 2019
• Last Update Posted: February 5, 2020
• Last Verified: February 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No