Effect of Elastic Abdominal Binder on Pain and Functional Recovery Following Gynecologic Cancer Surgery: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gynecologic Cancer
- Sponsor
- Chiang Mai University
- Enrollment
- 109
- Locations
- 1
- Primary Endpoint
- Daily average postoperative pain scores
- Status
- Completed
- Last Updated
- 6 years ago
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.
Investigators
Kittipat Charoenkwan, MD
Associate Professor
Chiang Mai University
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
Outcomes
Primary Outcomes
Daily average postoperative pain scores
Time Frame: 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).
Six-minute walk test score change from baseline
Time Frame: One day before operation and postoperative day 3
Six-minute walk test (6MWT)
Secondary Outcomes
- Quality of life: EuroQol Group's ED-5D-5L questionnaire(In the morning of postoperative day 3)
- Rate of postoperative complications(In the morning, up to 7 days postoperation)