Elastic Abdominal Binder After Open Abdominal Surgery for Benign Gynecologic Conditions

NCT03820115 | Completed

• 1 other identifier: OBG-2561-05421
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Rate of postoperative complications

  In the morning, up to 7 days postoperation

Study Arms (2)

Elastic abdominal binder

EXPERIMENTAL

Device: Elastic abdominal binder

No binder

NO INTERVENTION

Interventions

Elastic abdominal binder DEVICE

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.

Elastic abdominal binder

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Kittipat Charoenkwan

Chiang Mai, 50200, Thailand

Location

MeSH Terms

Conditions

Genital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Kittipat Charoenkwan, MD, MSc

  Chiang Mai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: January 29, 2019
• Study Start: October 1, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

TH (1)