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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
458
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).
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.
The Sixth Affiliate Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITING3-year disease free survival rate
Time frame: 36 months after surgery
5-year overall survival rate
Time frame: 60 months after surgery
Incidence of postoperative complications
All postoperative complications in the perioperative period will be classified by the Clavien-Dindo classification.
Time frame: 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).
Time frame: 60 months after surgery
the operation time
The descriptive unit would be minute (min).
Time frame: in the perioperative period
the blood loss during the operation
The descriptive unit would be millilitre (ml)
Time frame: in the perioperative period
Postoperative recovery of intestinal peristalsis
The descriptive unit would be hour (h).
Time frame: 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).
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Time frame: 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.
Time frame: in the perioperative period
the mean postoperative hospitalization day
The descriptive unit would be day (d).
Time frame: in the perioperative period