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NCT Number: NCT07076901

Prehabilitation Strategies for Patients Undergoing Laparoscopic Sleeve Gastrectomy

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.

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Key information

Conditions

Obesity &Amp; Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050031, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

psychological support

Behavioral

A structured psychological intervention aimed at alleviating preoperative anxiety. It included one-on-one counseling, providing detailed information about the surgical procedure, introducing relaxation techniques and music therapy, and sharing success stories from previous patients to boost confidence. Support was provided via phone or WeChat video by a qualified psychological counselor.

Supervised exercise program

Behavioral

A daily guided exercise regimen including two components: 1) General physical conditioning consisting of at least 40 minutes of moderate-intensity aerobic and resistance training (e.g., brisk walking, jogging, cycling). 2) Respiratory function training consisting of abdominal breathing (5 times/hour) and balloon-blowing exercises (10 times/day). Patient adherence was monitored daily via a WeChat group.

Lifestyle and Dietary Modification

Behavioral

Focused on optimizing preoperative habits. Nutritional guidance involved a high-protein, high-vitamin diet with six smaller, frequent meals per day to adapt to post-surgery conditions. Lifestyle guidance included advising smoking and alcohol cessation and ensuring 6-8 hours of sleep per night. Daily dietary and sleep status were reported and monitored via a WeChat group.

Routine Perioperative Care

Other

Consisted of standard care practices before, during, and after surgery. Preoperative care included health education and fasting instructions. Intraoperative care included body temperature maintenance and vital signs monitoring. Postoperative care included 12-hour ECG monitoring, gradual reintroduction of a clear liquid diet 24 hours post-surgery, encouragement of early mobilization, and standard nursing for catheters and wounds.

Primary outcomes

  1. Time to recovery of bowel motility

    Time frame: Perioperative

    Time in days from surgery until the first audible bowel sounds.

  2. Time to first flatus

    Time frame: Perioperative

    Time in hours/days from surgery until the patient's first passage of flatus.

  3. Time to first bowel movement

    Time frame: Perioperative

    Time in days from surgery until the patient's first bowel movement.

  4. Time to first eating

    Time frame: Perioperative

    Time in hours/days from surgery until the patient starts clear liquids.

  5. Duration of hospital stay

    Time frame: Perioperative

    Total length of stay in the hospital, measured in days.

Secondary outcomes

  1. Change in Body Mass Index (BMI)

    Time frame: Baseline and 6 months post-surgery

    Change in BMI (kg/m²) from baseline to 6 months post-surgery.

  2. Change in Waist Circumference

    Time frame: Baseline and 6 months post-surgery

    Change in waist circumference (cm) from baseline to 6 months post-surgery.

  3. Quality of Life Score

    Time frame: Baseline and 6 months post-surgery

    Change in score on the Medical Outcomes Study Short Form 36 (MOS SF-36) Health Survey. The scale assesses eight dimensions, with higher scores indicating better quality of life.

  4. Incidence of Postoperative Complications

    Time frame: Perioperative and 6 months post-surgery

    The percentage of patients experiencing complications such as abdominal distention, bleeding, and anastomotic leak.

Sponsors and collaborators

Lead sponsor

The First Hospital of Hebei Medical University

Other

Registry information

Official study title

Effectiveness of Prehabilitation Strategies in Enhancing Recovery and Postoperative Outcomes in Laparoscopic Sleeve Gastrectomy Patients

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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