Clinical Trials Directory

Trials / Unknown

UnknownNCT05495217

A Clinical Study for Comparison of the Effects Between Gasless Laparoscopy and Conventional Laparoscopy for Distal Gastric Cancer

A Single-center, Randomized, Controlled Clinical Study for Comparison of the Effects Between Gasless Laparoscopy-assisted and Conventional Laparoscopy-assisted Gastrectomy With D2 Lymphadenectomy for Distal Gastric Cancer

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
200 (estimated)
Sponsor
Xue Yingwei · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

The aim of this trial is to confirm the non-inferiority of Gasless laparoscopy-assisted distal D2 radical gastrectomy to the conventional laparoscopy-assisted distal D2 radical gastrectomy for the treatment of advanced gastric cancer patients (T2-4a, N0-3, M0).

Detailed description

The primary end point was operative time for Gasless laparoscopy-assisted distal D2 radical gastrectomy and conventional laparoscopy-assisted distal D2 radical gastrectomy. The secondary outcomes of interest were intraoperative vital signs; postoperative pain; and surgeon satisfaction for D2 radical gastrectomy.

Conditions

Interventions

TypeNameDescription
DEVICEConventional LaparoscopyA procedure in which a laparoscope (LAPAROSCOPES) is inserted through a small incision near the navel to examine the abdominal and pelvic organs in the PERITONEAL CAVITY using Induced pneumoperitoneum.
DEVICEGasless LaparoscopyA procedure in which a laparoscope (LAPAROSCOPES) is inserted through a small incision near the navel to examine the abdominal and pelvic organs in the PERITONEAL CAVITY without Induced pneumoperitoneum.It mechanically elevates the abdominal wall and allows laparoscopic visualization through a single incision, providing diagnostic and therapeutic procedures.

Timeline

Start date
2021-12-01
Primary completion
2023-06-01
Completion
2023-12-01
First posted
2022-08-10
Last updated
2022-08-10

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05495217. Inclusion in this directory is not an endorsement.