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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04295473
Other study ID # 2020002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 2, 2020
Est. completion date March 1, 2027

Study information

Verified date April 2024
Source Nanchong Central Hospital
Contact Yunhong Tian, MD
Phone +86-13508087719
Email drtianyunhong@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Reduced port laparoscopic gastrectomy has been adopted in clinical. The safety and outcome of reduced port laparoscopic gastrectomy has not been systematically evaluated. The investigators sought to compare the short and long-term outcome of patients with gastric cancer who underwent reduced port gastrectomy with patients underwent traditional laparoscopic gastrectomy


Description:

Reduced port laparoscopic gastrectomy has been adopted in clinical. The safety and outcome of reduced port laparoscopic gastrectomy has not been systematically evaluated. The investigators designed a comparative study, which sought to compare the short and long-term outcome of patients with gastric cancer who underwent reduced port gastrectomy with patients underwent traditional laparoscopic gastrectomy. The short-term outcome include surgical complications, postoperative morbidity, postoperative nutrition. The long-term outcome mainly include long-term survival.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date March 1, 2027
Est. primary completion date March 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the stomach, T1-T4 stages. 2. Eastern Cooperative Oncology Group performance status of 0 or 1. 3. Adequate organ function. Exclusion Criteria: 1. Patients had distant metastasis. 2. oesophageal invasion of more than 3 cm. 3. Borrmann type 4 or large (more than 8 cm) type 3 carcinoma. 4. Previous chemotherapy or radiation therapy for any other malignancies.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Reduced port laparoscopic gastrectomy
The ports were reduced in the surgery of intervention arm.

Locations

Country Name City State
China Yunhong Tian Nanchong Sichuan

Sponsors (1)

Lead Sponsor Collaborator
Nanchong Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 5-year survival rate Longterm survival for patients with gastrectomy after reduced port laparoscopic gastrectomy 5 years
Primary 3-year survival rate Survival rate for patients with gastrectomy after reduced port laparoscopic gastrectomy 3 years
Secondary Postoperative morbidity rate Postoperative morbidity rate for patients with gastrectomy after reduced port laparoscopic gastrectomy 6 months
Secondary Malnutrition rate Malnutrition rate for patients with gastrectomy after reduced port 6 months
Secondary Quality of life in PGSAS-45 scale The quality of life were assessed using PGSAS-45 scale for patients with gastrectomy after reduced port laparoscopic gastrectomy. 12 months
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