Tubeless NOSES Versus Laparoscopic Radical Resection for Rectosigmoid Cancers

Not Applicable

Recruiting

• Conditions: Traditional Laparoscopic Radical Resection; Tubeless NOSES; Rectosigmoid Cancers
• Interventions: Procedure: Tubeless NOSES; Procedure: traditional laparoscopic radical resection

• Registration Number: NCT04037956
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief Summary

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.

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2019-07-16
• Study First Submitted QC: 2019-07-28
• Study First Posted: 2019-07-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-03-31
• Primary Completion: 2025-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 458

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tubeless NOSES	Tubeless NOSES	Patients receive Tubeless NOSES.
traditional laparoscopic	traditional laparoscopic radical resection	Patients receive traditional laparoscopic radical resection.

Primary Outcome Measures

Name	Time	Method
3-year disease free survival rate	36 months after surgery

Secondary Outcome Measures

Name	Time	Method
Incidence of postoperative complications	1 month after surgery	All postoperative complications in the perioperative period will be classified by the Clavien-Dindo classification.
the blood loss during the operation	in the perioperative period	The descriptive unit would be millilitre (ml)
the functional outcome of defecation	60 months after surgery	Anal incontinence was evaluated using the Wexner Continence Grading Scale , the score being calculated after the patients' completion of a daily defecatory questionnaire. Range is from 0 (normal continence) to 20 (maximum incontinence with maximum disturbance of lifestyle).
the operation time	in the perioperative period	The descriptive unit would be minute (min).
Pain score	in the perioperative period	A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain ( from 0 to 10).
number of cases converted to laparotomy	in the perioperative period	The procedure for cases who underwent traditional laparoscopic radical resection for those who cannot be done with traditional laparoscopic radical resection or Tubless NOSES and convert to laparotomy as a result，these should be recorded and compared within two experimental arms.
Postoperative recovery of intestinal peristalsis	in the perioperative period	The descriptive unit would be hour (h).
the mean postoperative hospitalization day	in the perioperative period	The descriptive unit would be day (d).
5-year overall survival rate	60 months after surgery

Trial Locations

Locations (1)

The Sixth Affiliate Hospital of Sun Yat-Sen University; 🇨🇳 GuangZhou, Guangdong, China