Elastic Abdominal Binder After Open Abdominal Surgery for Benign Gynecologic Conditions

Not Applicable

Completed

• Conditions: Gynecologic Disease
• Interventions: Device: Elastic abdominal binder

• Registration Number: NCT03820115
• Lead Sponsor: Chiang Mai University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-29
• Primary Completion: 2019-05-31
• Study Completion: 2019-05-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Elastic abdominal binder	Elastic abdominal binder	-

Primary Outcome Measures

Name	Time	Method
Six-minute walk test score change from baseline	One day before operation and postoperative day 3	Six-minute walk test (6MWT)
Daily average postoperative pain scores	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).

Secondary Outcome Measures

Name	Time	Method
Rate of postoperative complications	In the morning, up to 7 days postoperation	The complications of interest include febrile morbidity, wound complication, bowel ileus

Trial Locations

Locations (1)

Kittipat Charoenkwan; 🇹🇭 Chiang Mai, Thailand