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NCT Number: NCT07328633

Prehabilitation Plus ERAS in Gastric Cancer Surgery

This study aims to evaluate the impact of pre-habilitation combined with Enhanced Recovery After Surgery (ERAS) versus ERAS perioperative management alone on clinical outcomes in patients with gastric cancer undergoing neoadjuvant chemotherapy and laparoscopic (robotic) gastrectomy. The study is a single-center, randomized controlled trial involving patients aged 18-75 years. Participants will be randomly assigned to either a pre-habilitation program plus ERAS or ERAS alone. The primary outcome is the incidence of postoperative complications within 30 days. Secondary outcomes include pathological data, surgical outcomes, patient-reported outcomes, and long-term survival rates.

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Key information

Conditions

Gastric Cancer (GC) Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

About this study

The study is designed as a prospective, single-center, randomized, open-label, controlled clinical trial to compare the effects of pre-habilitation combined with ERAS versus ERAS alone in patients undergoing laparoscopic (robotic) gastrectomy after neoadjuvant chemotherapy for gastric cancer. The study will enroll patients aged 18-75 years who are scheduled for laparoscopic (robotic) gastrectomy following neoadjuvant chemotherapy. Participants will be randomly assigned in a 1:1 ratio to either the pre-habilitation plus ERAS group or the ERAS group. The pre-habilitation program will include a 4-week intervention involving exercise, nutrition, and psychological support prior to surgery. The primary endpoint is the incidence of postoperative complications within 30 days, assessed using the Clavien-Dindo classification. Secondary endpoints include pathological characteristics, surgical outcomes, patient-reported outcomes, and long-term survival rates. Data will be collected from patient records and follow-up visits. Statistical analysis will be performed using SPSS 26.0 or later versions, with significance level set at α=0.05.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age:18-75 years
  • ECOG:0-2
  • ASA:I-III
  • Histologically confirmed gastric adenocarcinoma (cT3-4aN+M0)
  • Fit for radical surgery after MDT
  • Negative pregnancy test within one month
  • Non-pregnant or non-lactating

Exclusion criteria

  • Severe cardiac (LVEF<30% or NYHA IV)
  • Severe hepatic or renal dysfunction (Child-Pugh ≥10; CrCl<25 ml/min)
  • Recent cerebrovascular events
  • Concomitant tumors requiring surgery
  • Emergency surgery for tumor complications,
  • Severe infections

Treatment and study plan

Pre-habilitation Program

Behavioral

A 4-week pre-habilitation program including exercise, nutrition, and psychological support aimed at improving physical and mental readiness for surgery.

Enhanced Recovery After Surgery (ERAS) Protocol

Procedure

Standard protocols for Enhanced Recovery After Surgery aimed at reducing postoperative complications and accelerating recovery.

Primary outcomes

  1. Incidence of Postoperative Complications

    Time frame: Postoperative 30-day

    The primary outcome measure is the incidence of postoperative complications within 30 days after surgery, assessed using the Clavien-Dindo classification system(CDC ≥ II).

Secondary outcomes

  1. Operation time

    Time frame: Intra-operative

    Time from skin incision to skin closure. Unit: minutes.

  2. Estimated blood loss

    Time frame: Intra-operative

    Total volume of intra-operative blood loss. Unit: mL.

  3. Pathological ypT stage

    Time frame: At pathology review (within 2 week after surgery)

    Tumour infiltration depth in the resection specimen according to AJCC 8th edition.

    Unit: n (%) - categories T0, T1, T2, T3, T4.

  4. Pathological ypN stage

    Time frame: At pathology review (within 2 week after surgery)

    Number of metastatic lymph nodes in the resection specimen. Unit: n (%) - categories N0, N1, N2, N3.

  5. AJCC pathological TNM stage

    Time frame: At pathology review (within 2 week after surgery)

    Combined pathological stage. Unit: n (%) - stages I, II, III.

  6. Tumour regression grade (TRG)

    Time frame: At pathology review (within 2 week after surgery)

    Degree of tumour response to neoadjuvant therapy according to Mandard criteria. Unit: n (%) - grades 0, 1, 2, 3.

  7. Time to first flatus

    Time frame: Post-operative period (up to 30 days)

    Interval from end of surgery to first rectal gas passage. Unit: days.

  8. Time to first liquid diet

    Time frame: Post-operative period (up to 30 days)

    Interval from end of surgery to first tolerated liquid intake. Unit: days.

  9. Post-operative hospital stay

    Time frame: Post-operative period.

    Interval from surgery to hospital discharge. Unit: days.

  10. Serum albumin level

    Time frame: Post-operative day 1,3,5.

    Serum albumin measured post-operatively. Unit: g/L.

  11. Tumour differentiation

    Time frame: At pathology review (within 2 week after surgery)

    Histological grade of the tumour. Unit: n (%) - well / moderate / poor.

Other outcomes

  1. Sex distribution

    Time frame: Baseline (day of enrollment)

    Biological sex at enrollment Unit: n (%) - Male, Female

  2. Height

    Time frame: Baseline (day of enrollment)

    Body height measured without shoes Unit: cm

  3. Weight

    Time frame: Baseline (day of enrollment)

    Body weight measured in light indoor clothing Unit: kg

  4. ECOG performance status

    Time frame: Baseline (day of enrollment)

    Eastern Cooperative Oncology Group performance score Unit: n (%) - scores 0, 1, 2

  5. Nutritional risk score (NRS 2002)

    Time frame: Baseline (day of enrollment)

    Nutritional Risk Screening 2002 total score Unit: n (%) - <3 vs ≥3

  6. ASA physical status classification

    Time frame: Baseline (day of enrollment)

    American Society of Anesthesiologists classification Unit: n (%) - classes 1, 2, 3

  7. Tumor diameter

    Time frame: Baseline (after neoadjuvant therapy, before surgery)

    Maximum diameter of the primary tumor on pre-operative imaging Unit: cm

  8. Clinical T stage

    Time frame: Baseline (after neoadjuvant therapy, before surgery)

    Clinical T category per AJCC 8th edition Unit: n (%) - cT2, cT3, cT4

  9. Clinical N stage

    Time frame: Baseline (after neoadjuvant therapy, before surgery)

    Clinical N category per AJCC 8th edition Unit: n (%) - cN0, cN1, cN2, cN3

  10. Six-minute walk test distance

    Time frame: Baseline (after neoadjuvant therapy, before surgery)

    Distance walked in 6 minutes on indoor flat track Unit: meters

  11. Hospital Anxiety and Depression Scale (HADS)

    Time frame: From the end of neoadjuvant therapy to the day before surgery, assessed up to 42 days.

    Anxiety and depression symptoms assessed with the 14-item HADS questionnaire; total score 0-21, higher scores indicate greater symptom severity.

    Unit: score (0-21)

  12. Health-related quality of life (EORTC QLQ-C30)

    Time frame: From the end of neoadjuvant therapy to the day before surgery, assessed up to 42 days.

    Assessed with the 30-item EORTC QLQ-C30 questionnaire; 15 domains (5 functional, 9 symptom/single-item, 1 global QoL). Raw scores are linearly transformed to 0-100 standard scores. Higher functional/global scores = better QoL; higher symptom scores = worse symptoms.

    Unit: score (0-100)

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Official study title

Effect of Pre-habilitation Combined With Enhanced Recovery After Surgery (ERAS) Versus ERAS Perioperative Management on Clinical Outcomes of Laparoscopic (Robotic) Gastrectomy in Patients With Gastric Cancer Receiving Neoadjuvant Chemotherapy: A Single-center Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

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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