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A prospective, multicenter, randomized controlled clinical trial of the safety of radical surgery for total laparoscopic distal gastrectomy for gastric cancer via natural orifice specimen extraction

A prospective, multicenter, randomized controlled clinical trial of the safety of radical surgery for total laparoscopic distal gastrectomy for gastric cancer via natural orifice specimen extraction

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071942
Enrollment
Unknown
Registered
2023-05-30
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Gastric cancer

Interventions

TLDG-NOSE:Complete laparoscopic radical resection of distal gastric cancer (D2) with transrectal or vaginal removal of the surgical specimen (no auxiliary incision in the anterior abdominal wall) and
LADG:Laparoscopic radical resection of distal gastric cancer (D2) with transabdominal incision.

Sponsors

Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 20 years old = age = 70 years old, regardless of gender, informed consent; The tumor was located in the middle and lower part of the stomach and was expected to undergo distal gastrectomy and D2 lymph node dissection. The clinical stage of the tumor was C/ycT1-3 N0-2M0; Maximum tumor diameter = 3 cm (male), = 5 cm (female); BMI < 25 kg/m2 (male), < 30 kg/m2 (female); Nutritional risk screening (NRS 2002) = 1 point There was no history of pelvic surgery; Gastric adenocarcinoma was diagnosed by endoscopic biopsy histopathology; Karnofsky score = 70, Eastern Cooperative Oncology Group (ECOG) performance status score = 2

Exclusion criteria

Exclusion criteria: Women who are unmarried and do not have children or plan to have children again, or women with acute gynecological infection or vaginal deformity; men with perianal diseases or anal stenosis; obese patients (male BMI > 25 kg/m2, female BMI > 30 kg/m2); preoperative imaging suggests distant organ metastasis, such as liver metastasis, lung metastasis, etc.;Patients with tumors complicated with acute gastrointestinal obstruction, perforation or bleeding, or requiring emergency surgery; patients with other malignant diseases or other malignant diseases within 5 years, or patients with other diseases requiring simultaneous surgery; patients with a history of continuous systemic corticosteroid or immunosuppressive drug therapy within 1 month;Severe heart, brain, liver, lung, kidney, hematopoietic system and other important organ diseases or dysfunction, can not be operated on.

Design outcomes

Primary

MeasureTime frame
postoperative complications;overall survival;

Secondary

MeasureTime frame
Intraoperative conversion to laparotomy rate;Postoperative abdominal pain scores;Time of first flatus after operation;Time of first food intake after surgery;Time of first defecation after operation;Average postoperative hospital stay;Assessment of postoperative quality of life;

Countries

China

Contacts

Public ContactBo Wei

Third Affiliated Hospital of Sun Yat-sen University

weibo3@mail.sysu.edu.cn+86 135 2779 4069

Outcome results

None listed

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