Prehabilitation Strategies for Patients Undergoing Laparoscopic Sleeve Gastrectomy

NCT07076901 | Completed

• 1 other identifier: 2023S00457
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity &Amp; Overweight

Keywords

Prehabilitation strategy; laparoscopic sleeve gastrectomy; weight loss outcomes; quality of life; postoperative complications

Outcome Measures

Primary Outcomes (5)

• Time to recovery of bowel motility

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

  Perioperative

• Time to first flatus

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

  Perioperative

• Time to first bowel movement

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

  Perioperative

• Time to first eating

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

  Perioperative

• Duration of hospital stay

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

  Perioperative

Secondary Outcomes (4)

• 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

Study Arms (2)

Observation Group (Prehabilitation)

EXPERIMENTAL

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.

Behavioral: Psychological Support; Behavioral: Supervised Exercise Program; Behavioral: Lifestyle and Dietary Modification

Control Group (Routine Care)

ACTIVE COMPARATOR

Participants received standard hospital perioperative care as per institutional protocol, without the specific, structured prehabilitation interventions provided to the observation group.

Other: Routine Perioperative Care

Interventions

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.

Observation Group (Prehabilitation)

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.

Observation Group (Prehabilitation)

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.

Observation Group (Prehabilitation)

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.

Control Group (Routine Care)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Hebei Medical University: lead

Study Sites (1)

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050031, China

Location

MeSH Terms

Conditions

Obesity; Overweight; Postoperative Complications

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 22, 2025
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

CN (1)