Postoperative Restrictions for Patients Undergoing Minimally Invasive Gynecologic Procedures
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Postoperative recovery
研究概览
简要总结
The goal of this randomized controlled trial is to assess recovery in patients undergoing benign laparoscopic gynecologic surgery. The main question it aims to answer is: do liberalized postoperative restrictions improve patient recovery after laparoscopic gynecologic surgery?
Researchers will compare postoperative recovery surveys from the control group (patients given standard postoperative restrictions limiting activity for 2 weeks) to the research group (patients given liberalized postoperative instructions allowing them to engage in their normal activities of daily life at their own discretion without prescribed activity restrictions) to see if liberalized postoperative restrictions improve the recovery experience.
Participants will be asked to fill out a brief questionnaire at two time intervals, 1 week after surgery and 2 weeks after surgery.
详细描述
The questionnaire will consist of the Recovery Index-10 (RI-10), a short recovery-specific instrument to assess subjective postoperative recovery that is specifically validated for gynecologic surgery. It is graded on a 5-point numerical Likert scale ranging from "full disagreement" to "full agreement." The questionnaire asks questions regarding pain, stamina/ability to complete daily chores, energy, and sleep.
In addition to the RI-10 survey, a few additional questions will be asked to assess whether the patient has dependents they are responsible for, if they have returned to work, and if they have resumed driving.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Greater than or equal to 18 years of age
- •English speaking (Spanish speaking to be added once appropriate forms are professionally translated and approved)
- •5-8 mm port sites used during the surgery
排除标准
- •Less than 18 years of age
- •Primary language other than English (or Spanish once forms are professionally translated and approved)
- •Use of port size >8mm
研究组 & 干预措施
Control. Patients to receive standard postoperative instructions.
Participants in the control group will receive standard postoperative instructions which would be given whether the patient was enrolled in this study or not. This includes written and verbal instructions not to lift anything heavier than 10 pounds, or partake in rigorous exercise (weightlifting, sit-ups) for at least 2 weeks postoperatively.
Study. Patients to receive liberalized postoperative instructions.
Participants in the study group will receive liberal postoperative instructions. This includes written and verbal instructions to resume normal activities of daily living without restriction at the discretion of the patient.
干预措施: Study Postoperative Care (Behavioral)
结局指标
主要结局
Postoperative recovery
时间窗: The RI-10 will be completed by the patient at two time points: 1 week post-surgery, and 2 weeks post-surgery
Postoperative recovery will be evaluated using the Recovery Index-10 (RI-10), a recovery-specific instrument to assess subjective postoperative recovery that is specifically validated for gynecologic surgery. It is graded on a 5-point numerical Likert scale ranging from "full disagreement" to "full agreement." The questionnaire asks questions regarding pain, stamina/ability to complete daily chores, energy, and sleep. Prior literature on the use and validation of RI-10 suggests a standard deviation of 20 and an effect size of 15.
次要结局
- Postoperative complications(Within 2 weeks postoperatively)
研究者
Anna Frappaolo
OBGYN Resident Physician
Women and Infants Hospital of Rhode Island