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Completed

NCT Number: NCT05541783

Laparoscopic-assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy for Gastric Cancer

The aim of this study is comparing the short-term quality of life between laparoscopy-assisted distal gastrectomy and totally laparoscopic distal gastrectomy for gastric cancer.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai Hospital, Shanghai, Shanghai Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 20-80 years;
  • Patients had an Eastern Cooperative Oncology Group performance status score of 0 or 1;
  • Patients had histologically confirmed gastric adenocarcinoma (tumor size<5cm) at clinical stage I-III with T1-4aN0-2M0 excluding T4b or N3 tumors, according to the of the American Joint Committee on Cancer classification system, eighth edition;
  • Patients were expected to undergo laparoscopic distal gastrectomy with D2 lymphadenectomy.

Exclusion criteria

  • Patients had bulky regional lymph nodes (larger than 3 cm at the long diameter) or possible distant metastasis in preoperative evaluation
  • Patients had history of chemotherapy, radiotherapy, immunotherapy or target therapy;
  • Patients had any concurrent or previous malignant tumor;
  • Patients had unstable cardiovascular, respiratory, kidney, or liver disease and poorly controlled hypertension, diabetes, mental disorders; history of upper abdominal surgery (except laparoscopic cholecystectomy).
  • Patients were histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy).

Treatment and study plan

laparoscopy-assisted distal gastrectomy Group

Procedure

LADG

totally laparoscopic distal gastrectomy

Procedure

TLDG

Primary outcomes

  1. Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire

    Time frame: 30 days postoperatively

    Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire at 30 days postoperatively

Secondary outcomes

  1. Scores on the other scales of EORTC QLQ-C30 questionnaire postoperatively

    Time frame: 30 days postoperatively

    Scores on the other scales of EORTC QLQ-C30 questionnaire at 30 days postoperatively

  2. Scores on EORTC QLQ-C30 questionnaire

    Time frame: 7 days and 90 days postoperatively

    Scores on EORTC QLQ-C30 questionnaire at 7 days and 90 days postoperatively

  3. Scores on the scales of EORTC QLQ-STO22 questionnaire postoperatively

    Time frame: 7，30 and 90 days postoperatively

    Scores on the scales of EORTC QLQ-STO22 questionnaire at 7，30 and 90 days postoperatively

  4. hospital stay cost

    Time frame: 30-day

  5. Intraoperative and postoperative morbidities and mortality

    Time frame: 90-day

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

A Multi-center Prospective Randomized Controlled Trial Comparing the Quality of Life Between Laparoscopic-assisted Distal Gastrectomy (LADG) and Totally Laparoscopic Distal Gastrectomy (TLDG) for Gastric Cancer

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 15, 2022
Registry last updated
Jun 30, 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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