Effectiveness of Prehabilitation Strategies in Enhancing Recovery and Postoperative Outcomes in Laparoscopic Sleeve Gastrectomy Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Time to first flatus
研究概览
简要总结
This study aims to evaluate the effectiveness of prehabilitation strategies in patients undergoing laparoscopic sleeve gastrectomy (LSG). The study compares a group receiving prehabilitation (including exercise, nutritional, and psychological support) with a control group receiving routine care. The primary goal is to determine if prehabilitation improves postoperative recovery, enhances weight loss, improves quality of life, and reduces complications.
详细描述
Obesity is a significant global health issue, and laparoscopic sleeve gastrectomy (LSG) is a common surgical treatment. However, the procedure is invasive and can cause physical and psychological stress, impacting postoperative recovery. Prehabilitation, a process of enhancing a patient's functional capacity before surgery, has shown promise in various surgical fields. This study investigates a "triad prehabilitation management mode," incorporating psychological intervention, nutritional support, and exercise training for patients undergoing LSG. This prospective, randomized controlled trial enrolled 120 patients assigned to either a prehabilitation group or a control group. The prehabilitation group received a structured program of exercise, nutritional guidance, and psychological support for 5-7 days before surgery, in addition to routine care. The control group received routine care only. The study hypothesizes that the prehabilitation strategy will lead to faster gastrointestinal function recovery, better weight loss outcomes, improved quality of life, and a lower rate of postoperative complications compared to routine care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obesity, defined by a body mass index (BMI) ≥35 kg/m².
- •Age between 18 and 50 years.
- •Failure of non-surgical weight loss methods.
- •Surgical eligibility for LSG based on clinical assessment.
- •Willingness to participate in the study and sign an informed consent form.
排除标准
- •Incomplete clinical data.
- •Inability to strictly adhere to dietary instructions.
- •Inability to complete follow-up visits.
- •Secondary obesity.
- •Presence of mental disorders, cognitive impairment, or consciousness disturbance.
- •Planned pregnancy within 1 year post-surgery.
研究组 & 干预措施
Observation Group (Prehabilitation)
Participants received a multi-component prehabilitation program for 5-7 days before surgery. The program consisted of structured psychological, exercise, and lifestyle interventions administered by a multidisciplinary team, in addition to routine perioperative care.
干预措施: Psychological Support (Behavioral)
Observation Group (Prehabilitation)
Participants received a multi-component prehabilitation program for 5-7 days before surgery. The program consisted of structured psychological, exercise, and lifestyle interventions administered by a multidisciplinary team, in addition to routine perioperative care.
干预措施: Supervised Exercise Program (Behavioral)
Observation Group (Prehabilitation)
Participants received a multi-component prehabilitation program for 5-7 days before surgery. The program consisted of structured psychological, exercise, and lifestyle interventions administered by a multidisciplinary team, in addition to routine perioperative care.
干预措施: Lifestyle and Dietary Modification (Behavioral)
Control Group (Routine Care)
Participants received standard hospital perioperative care as per institutional protocol, without the specific, structured prehabilitation interventions provided to the observation group.
干预措施: Routine Perioperative Care (Other)
结局指标
主要结局
Time to first flatus
时间窗: Perioperative
Time in hours/days from surgery until the patient's first passage of flatus.
Time to recovery of bowel motility
时间窗: Perioperative
Time in days from surgery until the first audible bowel sounds.
Time to first bowel movement
时间窗: Perioperative
Time in days from surgery until the patient's first bowel movement.
Time to first eating
时间窗: Perioperative
Time in hours/days from surgery until the patient starts clear liquids.
Duration of hospital stay
时间窗: Perioperative
Total length of stay in the hospital, measured in days.
次要结局
- Change in Body Mass Index (BMI)(Baseline and 6 months post-surgery)
- Change in Waist Circumference(Baseline and 6 months post-surgery)
- Quality of Life Score(Baseline and 6 months post-surgery)
- Incidence of Postoperative Complications(Perioperative and 6 months post-surgery)
研究者
Yankai Zhao
Principal Investigator
The First Hospital of Hebei Medical University