A Prospective Non-randomized Controlled Multi-center Study of Laparoscopic Intracorporeal Distal Rectal Transection by Using the Traditional Approach vs. Using Transanterior Obturator Nerve Gateway Approach for Ultralow Rectal Cancers
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- The degree of △Angle
研究概览
简要总结
The wide application of ISR and DST has greatly improved the anal preservation rate for low rectal cancers, but the technical difficulty has also been obviously increased because of the limited pelvic space. Although many scholars have tried to solve this problem, all the methods have failed to fundamentally solve the problem of "the oblique dissection" of the distal rectum. To solve the problem above, the director of this clinical trial has explored a new distal rectal resection method-- transanterior obturator nerve gateway approach. The purpose of this clinical trial is to prospectively collect and compare data on the patients' perioperative variables and postoperative functional and oncological outcomes of this novel approach with the traditional approach to confirm the safety and feasibility of this novel approach and its advantages over the traditional approach.
详细描述
Objective To confirm the safety, feasibility and advantages by comparing the perioperative variables, postoperative functional and oncological outcomes of patients with ultralow rectal cancer treated by laparoscopic traditional distal rectal dissection vs. by transanterior obturator nerve gateway approach.
Patients Patients with ultralow (≤5cm from the anal verge) rectal cancer who are to undergo laparoscopic radical resection (ISR- DST) without any contraindications of general anesthesia, surgery or chemotherapy. (See details in Eligibility part) Sample size Two groups are designed, patients who are to receive the traditional approach to transect the distal rectum are assigned to the control group, patients who are to receive the transanterior obturator nerve gateway approach to transect the distal rectum are assigned to the experimental group. 100 cases are to be enrolled for the experimental group and not less than 100 cases are to be enrolled for the controlled group.
Treatment If the participant match with the requirements for this study and agree to take part in it, once hospitalized, the participant will complete the established preoperative tests including blood routine, the comprehensive metabolic panel, blood coagulation function, tumor markers, blood type, infectious disease screening tests, chest, abdominal and pelvic CT (Computed Tomography) scan and MRI (Magnetic Resonance Imaging), colonoscopy, echocardiogram, pulmonary function, venous duplex ultrasound of legs. All male patients will be routinely asked to fill in the IIEF-5 (International Index of Erectile Function-5) sexual function scoring questionnaire preoperatively.
The following comprehensive treatment will be depended on the examination results:
Neoadjuvant therapy The treatment plan will be made in accordance with the NCCN (National Comprehensive Cancer Network) Guidelines for Diagnosis and Treatment of Colorectal Cancer (Version 1.2021).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically diagnosed as rectal cancer with the lower margin of the tumor from the anal margin ≤5cm；CT, MRI or endoscopic ultrasonography: Single tumor, clinical T stage ≤3 or no invasion of the internal sphincter, maximum diameter ≤10cm, no distant metastasis；The patient or the patient-authorized representative completely understands the study protocol and voluntarily participates in this study, agrees to sign written informed consent.
排除标准
- •The patient had previous abdominal surgery that will significantly infect the laparoscopic procedures; Patients requiring emergency surgery owing to intestinal obstruction, perforation, or uncontrolled bleeding caused by tumor; Patients with poor anal function preoperatively (Wexner score ≥10); ASA (American Society of Anesthesiologists) grading ≥ IV; Pregnant patients; Patients concomitant with severe mental illness; The patient or the patient-authorized representative can't understand the contents and objectives of the study.
- •Withdraw criteria： ISR cannot be performed by intraoperative evaluation and is replaced by Miles surgery; Distant metastasis is confirmed intraoperatively or by postoperative pathological findings; Patients had other primary tumors requiring surgical/drug treatment during the study, or had other illnesses that prevent the patient from continuing to participate this study; Patients decide to withdraw from the study for any reason, or who are unable to complete the study because of any objective reasons.
结局指标
主要结局
The degree of △Angle
时间窗: The degree of △Angle will be measured on the resected specimen immediately after the surgery.
The degree of angle between the simulated stapling line with the total mesorectal excision approach and the real stapling line with the transanterior obturator nerve gateway approach (this outcome is measured only in patients of the experimental group).
The degree of Angle
时间窗: The degree of Angle will be measured on the resected specimen immediately after the surgery.
The degree of angle between the linear stapler and the longitudinal axis of the rectum when transecting the distal rectum.
Length of distal resection margin
时间窗: Length of distal resection margin will be measured by the operator immediately after the surgery and by the pathologist during the pathological test within a week after surgery, the final outcome will be the mean value of the two.
The shortest distance between the distal border of the tumor and the edge of the distal resection.
Rate of conversion to transanal transection and anastomosis of the rectum.
时间窗: The gross conversion rate will be calculated immediately after the last patient's surgery.
The gross conversion rate (No. of cases undergoing conversion/total No. of cases enrolled \*100%) will be calculated immediately after the last patient's surgery.
Rate of anastomotic leakage
时间窗: For each case, whether complicated with anastomotic leakage will be supervised up to 6 months after surgery. The gross rate of anastomotic leakage will be calculated 6 months after the last patient's surgery.
The gross anastomotic leakage rate (No. of cases diagnosed with anastomotic leakage/total No. of cases enrolled \*100%) will be calculated 6 months after the last patient's surgery. Anastomotic leakage will be diagnosed if the patient has clinically apparent leakage signs (such as the emission of gas, pus, or feces from the pelvic drain, or peritonitis) or extravasation of endoluminally administered watersoluble contrast medium according to CT.
次要结局
- Volume of blood loss(The gross volume of blood loss during the operation will be measured and recorded immediately after the surgery.)
- 3-year disease-free survival(Survival without cancer relapse or metastasis after 3 years from operation or till cancer relapse/metastasis/death/loss of follow-up within 3 years from operation will be recorded for each patient.)
- Postoperative urinary retention in hospital(Whether there is urinary retention will be recorded before discharge from hospital or up to 30 days after surgery for each patient.)
- Wexner score(Anal function evaluated by Wexner score will be assessed 3 and 12 months after stoma closure)
- 3-year overall survival(Survival information after 3 years from operation or till death/loss of follow-up within 3 years from operation will be collected for each patient.)
- Operative time(Operative time will be recorded immediately after the surgery.)
- Length of stapling line(Length of stapling line will be measured directly on the resected specimen immediately after the surgery.)
- Anastomotic height from anal verge(Anastomotic height will be measured and recorded by the operator using digital rectal exam immediately after the surgery.)
- Postoperative hospital stay(Postoperative hospital stay will be recorded on the day the patient is discharged from hospital.)
- International prostate symptom score (IPSS)(Dysuria will be assessed by IPSS scale 1 month after surgery)
- International Index of Erectile Function (IIEF-5) score(Sexual function will be assessed by IIEF-5 scale 1 week before surgery and 12 months after surgery)