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临床试验/NCT03818633
NCT03818633已完成不适用

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

Chiang Mai University2 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2018年4月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
109
试验地点
2
主要终点
Daily average postoperative pain scores

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Daily average postoperative pain scores

时间窗: 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

时间窗: One day before operation and postoperative day 3

Six-minute walk test (6MWT)

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kittipat Charoenkwan, MD

Associate Professor

Chiang Mai University

研究点 (2)

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