Elastic Abdominal Binder Following Gynecologic Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Effect of Elastic Abdominal Binder on Pain and Functional Recovery Following Gynecologic Cancer Surgery: a Randomized Controlled Trial

Conditions
-----------------
Gynecologic Cancer

Intervention / Treatment
-----------------
* Device: Elastic abdominal binder


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elastic abdominal binder<br> | Device: Elastic abdominal binder<br>* 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.<br>|
| No Intervention: No binder<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life: EuroQol Group's ED-5D-5L questionnaire | The EuroQol Group's ED-5D-5L questionnaire is employed. The health dimensions assessed include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, the participants are asked to indicate their health state related to that dimension as no problems (score '1'), slight problems (score '2'), moderate problems (score '3'), severe problems (score '4'), and extreme problems (score '5'). For this study, a score of 1-2 is considered normal while a scores of 3-5 is regarded as problem. In addition, the participants are asked to rate their overall health status according to a visual analog scale EQ VAS with '0' corresponding to the worst health imaginable and '100' indicating the best health imaginable. | In the morning of postoperative day 3 | 
| Rate of postoperative complications | The complications of interest include febrile morbidity, wound complication, bowel ileus | In the morning, up to 7 days postoperation |