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Recruiting NCT04037956

Tubeless NOSES Versus Laparoscopic Radical Resection for Rectosigmoid Cancers

No phase Interventional Tubeless NOSES Traditional Laparoscopic Radical Resection Rectosigmoid Cancers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tubeless NOSES, traditional laparoscopic radical resection.
Who it may be relevant to
Registry conditions: Tubeless NOSES, Traditional Laparoscopic Radical Resection, Rectosigmoid Cancers. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Perspective Study to Compare the Tubeless NOSES and Traditional Laparoscopic Radical Resection in Rectosigmoid Cancers (CORNER)

Overview

This study is designed to evaluate the short-term and long-term results after Tubeless NOSES for the resection of Rectosigmoid Cancers compared with traditional laparoscopic radical resection.

Detailed description

This is a randomized, single-center, open-label, non- inferiority study designed to evaluate the safety, efficacy and potential benefits of Tubeless NOSES compared with traditional laparoscopic radical resection in approximately 458 subjects with Rectosigmoid Cancers.

Interventions

  • Procedure Tubeless NOSES
    The whole procedures undergo by total laparoscopic surgery with no specimen extraction incision in the abdominal wall. The specimen then will be removed through natural orifice such (anal).
  • Procedure traditional laparoscopic radical resection
    The traditional laparoscopic operation undergo and then a small incision(5-8cm) is made in the middle of the lower abdominal wall to remove the specimen.

Primary outcome measures

  • 3-year disease free survival rate [Time frame: 36 months after surgery]
Secondary outcome measures (9)
  • 5-year overall survival rate [Time frame: 60 months after surgery]
  • Incidence of postoperative complications [Time frame: 1 month after surgery]
  • the functional outcome of defecation [Time frame: 60 months after surgery]
  • the operation time [Time frame: in the perioperative period]
  • the blood loss during the operation [Time frame: in the perioperative period]
  • Postoperative recovery of intestinal peristalsis [Time frame: in the perioperative period]
  • Pain score [Time frame: in the perioperative period]
  • number of cases converted to laparotomy [Time frame: in the perioperative period]
  • the mean postoperative hospitalization day [Time frame: in the perioperative period]

Eligibility criteria

Inclusion criteria

  • Histologically or cytologically confirmed Rectosigmoid Cancers
  • Clinical stage at T 1-3 N0-2 M0
  • Tumors on peritoneal reflection，Tumor size is no more than 3 cm
  • Eastern Cooperative Oncology Group (ECOG) scale is 0-2
  • American Society of Anesthesiologists (ASA) score is Ⅰ-Ⅲ
  • BMI ≤ 30 kg/m2
  • Subjects must be willing and able to comply with scheduled visits, treatment schedule,and laboratory testing.

Exclusion criteria

  • Heart, lung, liver or renal or any organ function that are intolerance for surgery
  • History of treated colorectal malignant disease
  • Subjects with medical condition, such as intestinal obstruction, intestinal perforation, bleeding, requires emergency surgery
  • Subjects with previous malignancies
  • History of inflammatory bowl disease(IBD) or familial adenomatous polyposis (FAP)
  • Treatment with any other clinical trial within 28 days prior to randomization
  • History of severe mentally disease
  • pregnant or lactating women
  • The researchers believe that the patients are unsuitable to participate in the researchers with other cases.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Sixth Affiliate Hospital of Sun Yat-Sen University — Guangzhou

Identifiers

NCT: NCT04037956 · SixthSunYetSen-Lyx

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗