Rectosigmoid Cancers, Traditional Laparoscopic Radical Resection, Tubeless NOSES
Conditions
Keywords
Tubeless NOSES, traditional laparoscopic radical resection, Rectosigmoid Cancers
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.
Interventions
PROCEDURETubeless 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).
PROCEDUREtraditional 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.
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease free survival rate | 36 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative complications | 1 month after surgery | All postoperative complications in the perioperative period will be classified by the Clavien-Dindo classification. |
| 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). |
| the blood loss during the operation | in the perioperative period | The descriptive unit would be millilitre (ml) |
| 5-year overall survival rate | 60 months after surgery | — |
| 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. |
| the mean postoperative hospitalization day | in the perioperative period | The descriptive unit would be day (d). |
| Postoperative recovery of intestinal peristalsis | in the perioperative period | The descriptive unit would be hour (h). |
Countries
China
Contacts
Primary ContactYanxin Luo, MD，PHD
Backup ContactJinxin Lin, MD，PHD
Outcome results
None listed