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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tubeless NOSES | Experimental | Patients receive Tubeless NOSES. |
|
| traditional laparoscopic | Active Comparator | Patients receive traditional laparoscopic radical resection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tubeless NOSES | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease free survival rate | 36 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year overall survival rate | 60 months after surgery | |
| Incidence of postoperative complications | All postoperative complications in the perioperative period will be classified by the Clavien-Dindo classification. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanxin Luo, MD,PHD | Contact | 86-13826190263 | luoyx25@mail.sysu.edu.cn | |
| Jinxin Lin, MD,PHD | Contact | 86-18998815200 | linjx69@mail2.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yanxin Luo, phD | The Sixth Affiliate Hospital of Sun Yat-Sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sixth Affiliate Hospital of Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | China |
There is no plan to make individual participant data (IPD) available to other researchers.
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| traditional laparoscopic radical resection | Procedure | 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. |
|
| 1 month after surgery |
| the functional outcome of defecation | 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). | 60 months after surgery |
| the operation time | The descriptive unit would be minute (min). | in the perioperative period |
| the blood loss during the operation | The descriptive unit would be millilitre (ml) | in the perioperative period |
| Postoperative recovery of intestinal peristalsis | The descriptive unit would be hour (h). | in the perioperative period |
| Pain score | 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). | in the perioperative period |
| number of cases converted to laparotomy | 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. | in the perioperative period |
| the mean postoperative hospitalization day | The descriptive unit would be day (d). | in the perioperative period |