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Trial Title:
A Randomized, Controlled, Multicenter, Noninferiority Clinical Study of Perioperative and Oncological Safety in Patients With Rectal Cancer
NCT ID:
NCT05503381
Condition:
Department of Anorectal Surgery, Changhai Hospital Affiliated to Naval Medical University
Conditions: Official terms:
Rectal Neoplasms
Conditions: Keywords:
Colorectal cancer;Natural Orifice Specimen Extraction Surgery;Disease-free survival
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized, controlled, multicenter, noninferiority clinical study
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Laparoscopic radical resection of low rectal cancer with transanal specimens
Description:
According to the standard laparoscopic anterior rectum resection, the rectum was
separated 2-3cm below the tumor, the rectum was severed 1-2cm from the lower edge of the
tumor, the rectal stump was connected with the tumor through the anus, and the sigmoid
colon was severed 10cm from the upper edge of the tumor. The stapler head was placed in
the sigmoid colon stump, and then the sigmoid colon stump was closed with a linear
cutting closure device. Then, the sigmoid colon stump is returned to the abdominal cavity
through the anus, the distal rectal stump is closed with a suture purse or a linear
cutting closure device, and the stapler body is inserted through the anus, and then the
anastomosis is completed.
Arm group label:
Natural Orifice Specimen Extraction Surgery Group
Summary:
Laparoscopic natural orifice specimen extraction surgery (NOSES) for low rectal cancer
has a good minimally invasive effect. However, the NOSES prognosis studies are all small
sample retrospective studies. This study conducted a multicenter prospective randomized
controlled trial of NOSES surgery for low rectal cancer to compare the difference in
surgical outcomes between conventional laparoscopic surgery and NOSES surgery for low
rectal cancer. A total of 500 patients were planned to be enrolled, including 250 in the
control group and 250 in the experimental group. The primary end point was 2-year
disease-free survival (DFS), and the secondary end points were surgical safety,
postoperative pathology, postoperative defecation, urination, and sexual function.
Through a large sample size study, this study aims to clarify the advantages of NOSE
surgery for low rectal cancer, promote the promotion of low rectal cancer NOSES surgery
in the country, standardize the way of low rectal cancer NOSES surgery, improve the
surgical treatment of patients with low rectal cancer, improve the quality of life of
patients, reduce the burden of patients, and increase the satisfaction. And improve the
international influence of the project team in the field of minimally invasive surgical
treatment of colorectal cancer.
Detailed description:
Research Objectives:
1. To compare the difference in the oncological effect between laparoscopic radical
resection of low rectal cancer with anal specimens (NOSES I type) and laparoscopic
assisted surgery for low rectal cancer;
2. To compare the safety of laparoscopic radical resection of low rectal cancer with
anal specimens (NOSES I type) and laparoscopic assisted surgery for low rectal
cancer within 30 days of perioperative period;
3. To explore the difference in the prophylactic stoma implementation and the positive
rate of tumor cells in pelvic flushing fluid between laparoscopic radical resection
of low rectal cancer with anal specimens (NOSES I) and laparoscopic assisted
resection of lower rectal cancer.
Primary end Point: 2-year Disease-free survival (DFS) Secondary end points :(1) incidence
of SSI; (2) Incidence of serious postoperative complications (anastomotic leakage,
postoperative bleeding, etc.); (3) R0 removal rate; (4) Postoperative recovery (pain,
exhaust and defecation time, eating time, postoperative hospital stay, etc.); (5)
Postoperative pathological conditions (distance between upper and lower margins, number
of lymph nodes, circumferential margins, etc.); (6) 2-year RFS and OS.
Exploratory end points :(1) prophylactic colostomy rate; (2) Positive rate of tumor cells
in pelvic flushing fluid.
Inclusion criteria:
1. Patients aged 18-75 years;
2. Adenocarcinoma confirmed by pathology;
3. colonoscopy or imaging examination confirmed that the distance between the lower
edge of the tumor and the anal edge was less than 5cm;
4. Preoperative imaging diagnosis was CT1-3NXM0;
5. Preoperative colonoscopy or imaging diagnosis confirmed that the maximum diameter of
the tumor was not more than 5cm;
6. Body Mass Index (BMI)≤30kg/m2;
7. No local complications (no obstruction, incomplete obstruction, massive active
bleeding, no perforation) Formation of pores and abscesses without invasion of
adjacent organs);
8. The hematopoietic functions of heart, lung, liver, kidney and bone marrow meet the
requirements of surgery and anesthesia;
9. Voluntarily sign the informed consent form.
Exclusion criteria:
1. Preoperative evaluation of lateral lymph node metastasis;
2. Previous history of malignant tumor;
3. Simultaneous multiple primary colorectal cancer;
4. Patients with contraindications of laparoscopic surgery, such as severe
cardiopulmonary insufficiency;
5. Previous multiple abdominal and pelvic surgeries or extensive abdominal adhesions;
6. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding,
etc., requiring emergency surgery;
7. Patients with familial adenomatous polyposis, Lynch syndrome associated rectal
cancer, and active inflammatory bowel disease;
8. have a history of serious mental illness;
9. pregnant or lactating women;
10. Patients with uncontrolled infection before operation;
11. The investigator did not consider the patient to be eligible for the trial.
Exit Criteria:
1. Patients with distant metastasis confirmed by intraoperative exploration or
postoperative pathology, including liver, pelvic cavity, ovary, peritoneum, distant
lymph node metastasis, etc.;
2. Intraoperative exploration was necessary for combined organ resection;
3. After enrollment in the study, patients requiring emergency surgical resection due
to intestinal obstruction, intestinal perforation, intestinal bleeding, etc.
4. Patients who requested to withdraw from the study cohort for various reasons after
enrollment;
5. Those who fail to complete the institute planning for various reasons after being
enrolled in the study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients were aged between 18 and 75 years;
2. Pathologically confirmed as adenocarcinoma;
3. Colonoscopy or imaging examination confirmed that the distance between the lower
edge of the tumor and the anal margin was ≤ 5cm;
4. Preoperative imaging diagnosis was ct1-3nxm0;
5. Preoperative colonoscopy or imaging diagnosis confirmed that the maximum diameter of
the tumor was not more than 5cm;
6. Body mass index (BMI) ≤ 30kg / m2;
7. No local complications (no obstruction, incomplete obstruction, no massive active
bleeding, no puncture Formation of pores and abscesses without invasion of adjacent
organs);
8. The hematopoietic functions of heart, lung, liver, kidney and bone marrow meet the
requirements of surgery and anesthesia;
9. Voluntary informed consent.
Exclusion Criteria:
1. Preoperative evaluation of patients with lateral lymph node metastasis;
2. Previous history of malignant tumor;
3. Simultaneous multiple primary colorectal cancer was diagnosed;
4. There are contraindications to laparoscopic surgery, such as severe cardiopulmonary
insufficiency;
5. Patients who had undergone abdominal and pelvic surgery for many times or had
extensive abdominal adhesions;
6. Patients with intestinal obstruction, intestinal perforation, intestinal hemorrhage
and other emergency operations;
7. Patients with familial adenomatous polyposis, Lynch syndrome associated rectal
cancer, and inflammatory bowel disease in the active phase;
8. Have a history of serious mental illness;
9. Pregnant or lactating women;
10. Patients with uncontrolled infection before operation;
11. The investigator considered that the patient should not participate in the trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
January 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Changhai Hospital
Agency class:
Other
Source:
Changhai Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05503381