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Prehabilitation Strategies for Patients Undergoing Laparoscopic Sleeve Gastrectomy

H

Hebei Medical University

Status

Completed

Conditions

Obesity &Amp; Overweight

Treatments

Other: Routine Perioperative Care
Behavioral: Supervised Exercise Program
Behavioral: Psychological Support
Behavioral: Lifestyle and Dietary Modification

Study type

Interventional

Funder types

Other

Identifiers

NCT07076901
2023S00457

Details and patient eligibility

About

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.

Full description

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.

Enrollment

120 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Observation Group (Prehabilitation)
Experimental group
Description:
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.
Treatment:
Behavioral: Lifestyle and Dietary Modification
Behavioral: Psychological Support
Behavioral: Supervised Exercise Program
Control Group (Routine Care)
Active Comparator group
Description:
Participants received standard hospital perioperative care as per institutional protocol, without the specific, structured prehabilitation interventions provided to the observation group.
Treatment:
Other: Routine Perioperative Care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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