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Total laparoscopic gastrectomy with double circular stapler for reconstruction of digestive system through natural orifice

Total laparoscopic gastrectomy with double circular stapler for reconstruction of digestive system through natural orifice

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052716
Enrollment
Unknown
Registered
2021-11-04
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric carcinoma

Interventions

experimental group 1:The digestive tract was reconstructed through a posterior fornix incision and specimens were removed
experimental group 2:The digestive tract was reconstructed through rectal incision and specimens were removed
control group:Routine five-hole laparoscopic assisted total gastrectomy

Sponsors

Second Affiliated Hospital of Army Military Medical University (Xinqiao Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with stage II and III gastric cancer and gastric tumors requiring total gastrectomy. 2. Aged 25-75 years. 3. Agree to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Contraindications for laparoscopic gastrectomy such as: severe cardiopulmonary dysfunction, severe abdominal adhesions, etc.; 2. Those who are unmarried or have no children or those who plan to have children again; 3. Those who have gynecological diseases are not suitable for vaginal operation; 4. Those with insufficient bowel preparation; 5. Those with rectal stricture or rectal disease who are not suitable for rectal operation; 6. Acute gastric retention and perforation caused by tumor; 7. There are high-risk factors for anastomotic leakage (diabetes, application of immunosuppressive agents, severe malnutrition, radiotherapy and chemotherapy, etc.); 8. Patients who participate in other clinical trials at the same time; 9. The distance from the xiphoid process to the pubic tubercle is >30cm (limited by the working length of the stapler handle (35cm)); 10. Patients or their family members refuse to sign the informed consent; 11. Other conditions in which the investigator believes that the patient should not participate in this trial.

Design outcomes

Primary

MeasureTime frame
Surgical safety and feasibility indicators;Evaluation of surgical efficacy;Evaluation of minimally invasive effect;Evaluation of surgical complications;

Secondary

MeasureTime frame
Evaluation of operation time;Surgical cost evaluation;Length of stay and hospitalization costs of subjects;

Countries

China

Contacts

Public ContactMa Dan

Second Affiliated Hospital of Army Military Medical University (Xinqiao Hospital)

1054727918@qq.com+86 15823555665

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026