Elastic Abdominal Binder Following Gynecologic Cancer Surgery

Chiang Mai University

Status: Completed

Conditions: Gynecologic Cancer

Treatments: Device: Elastic abdominal binder

Study type: Interventional

Funder types: Other

Identifiers

NCT03818633

OBG-2560-05147

Details and patient eligibility

About

Surgery is the primary treatment for gynecologic malignancies. The surgical approach provides opportunities for removal of the affected organs and complete assessment of extent of cancer spread. However, the procedures are often associated with significant morbidity. This is especially true with open laparotomy, the most frequently employed approach in developing countries. 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 cancer patients who use versus do not use the elastic abdominal binder to support incisional site.

Enrollment: 109 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women, diagnosed with gynecologic malignancies (carcinoma of the cervix, endometrium, and ovary), undergoing open abdominal surgery

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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109 participants in 2 patient groups

Elastic abdominal binder

Experimental group

Treatment:

Device: Elastic abdominal binder

No binder

No Intervention group