Prehabilitation Strategies for Patients Undergoing Laparoscopic Sleeve Gastrectomy

NCT ID: NCT07076901

Last Updated: 2025-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity &Amp; Overweight

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Psychological Support

Intervention Type 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

Intervention Type 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

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Routine Perioperative Care

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Psychological Support

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.

Intervention Type BEHAVIORAL

Supervised Exercise Program

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.

Intervention Type BEHAVIORAL

Lifestyle and Dietary Modification

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.

Intervention Type BEHAVIORAL

Routine Perioperative Care

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The First Hospital of Hebei Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yankai Zhao

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023S00457

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.