Elastic Abdominal Binder After Open Abdominal Surgery for Benign Gynecologic Conditions

NCT ID: NCT03820115

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Elastic abdominal binder

Group Type: EXPERIMENTAL

Elastic abdominal binder

Intervention Type: 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.

No binder

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chiang Mai University

OTHER

Sponsor Role: lead

Responsible Party

Kittipat Charoenkwan, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kittipat Charoenkwan, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Chiang Mai University

Locations

Kittipat Charoenkwan

Chiang Mai, , Thailand

Countries

Thailand

Other Identifiers

OBG-2561-05421

Identifier Type: -

Identifier Source: org_study_id