A Study on the Efficacy of a Novel Approach to Achieving Laparoscopic Distal Rectal Transection for Rectal Cancers
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ClinicalTrials.gov Identifier: NCT05067413 |
Recruitment Status :
Enrolling by invitation
First Posted : October 5, 2021
Last Update Posted : October 5, 2021
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Condition or disease | Intervention/treatment | Phase |
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Rectal Neoplasms Malignant | Procedure: Transanterior obturator nerve gateway approach Procedure: Total mesorectal excision approach | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Care Provider) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | December 1, 2020 |
Estimated Primary Completion Date : | December 1, 2022 |
Estimated Study Completion Date : | December 1, 2025 |
Arm | Intervention/treatment |
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Sham Comparator: Total mesorectal excision approach
Patients of the control group who are to receive the traditional approach-- total mesorectal excision approach to transect the distal rectum are assigned into this arm.
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Procedure: Total mesorectal excision approach
Distal rectal transection of cases in the control group will be performed using total mesorectal excision approach |
Experimental: Transanterior obturator nerve gateway approach
Patients of the experimental group who are to receive the novel approach-- transanterior obturator nerve gateway approach to transect the distal rectum are assigned into this arm.
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Procedure: Transanterior obturator nerve gateway approach
Distal rectal transection of cases in the experimental group will be performed using transanterior obturator nerve gateway approach |
- The degree of Angle [ Time Frame: 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.
- The degree of △Angle [ Time Frame: 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).
- Length of distal resection margin [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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.
- Operative time [ Time Frame: Operative time will be recorded immediately after the surgery. ]The time between the first incision and final closure of the operation.
- Volume of blood loss [ Time Frame: The gross volume of blood loss during the operation will be measured and recorded immediately after the surgery. ]The gross volume of blood loss during the operation.
- Anastomotic height from anal verge [ Time Frame: Anastomotic height will be measured and recorded by the operator using digital rectal exam immediately after the surgery. ]Distance between the coloanal anastomosis and the anal verge.
- Length of stapling line [ Time Frame: Length of stapling line will be measured directly on the resected specimen immediately after the surgery. ]The length of the lower stapling margin of the specimen.
- Postoperative hospital stay [ Time Frame: Postoperative hospital stay will be recorded on the day the patient is discharged from hospital. ]Days from operation to discharge from hospital.
- Postoperative urinary retention in hospital [ Time Frame: Whether there is urinary retention will be recorded before discharge from hospital or up to 30 days after surgery for each patient. ]Urinary retention is defined as requiring a second urinary catheterization or postvoid residual urine volume ≥ 50ml by ultrasound examination after first removal of the urinary catheter.
- International prostate symptom score (IPSS) [ Time Frame: Dysuria will be assessed by IPSS scale 1 month after surgery ]See IPSS scale in study protocol. Total score: 0-35 points, higher scores mean worse outcome.
- Wexner score [ Time Frame: Anal function evaluated by Wexner score will be assessed 3 and 12 months after stoma closure ]See Wexner score in study protocol. Total score: 0-20 points, higher scores mean worse outcome.
- International Index of Erectile Function (IIEF-5) score [ Time Frame: Sexual function will be assessed by IIEF-5 scale 1 week before surgery and 12 months after surgery ]See IIEF-5 scale in study protocol. Total score: 5-25 points, higher scores mean better outcome.
- 3-year overall survival [ Time Frame: 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. ]The percentage of people who are alive after 3 years from operation.
- 3-year disease-free survival [ Time Frame: 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. ]The percentage of patients who are alive without cancer relapse or metastasis after 3 years from operation.
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Exclusion Criteria:
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05067413
China, Inner Mongolia | |
The Second Affiliated Hospital of Baotou Medical University | |
Baotou, Inner Mongolia, China, 014030 | |
China, Liaoning | |
Dalian University Affiliated Xinhua Hospital | |
Dalian, Liaoning, China, 116000 | |
China, Shandong | |
Shengli Oilfield Hospital | |
Dongying, Shandong, China, 257034 | |
China, Shanxi | |
The Third People's Hospital of Datong | |
Datong, Shanxi, China, 037001 |
Study Chair: | Jianqiang Tang, MD | Peking University First Hospital |
Documents provided by Peking University First Hospital:
Responsible Party: | Peking University First Hospital |
ClinicalTrials.gov Identifier: | NCT05067413 |
Other Study ID Numbers: |
2020149 320.6750.2021-04-2 ( Other Grant/Funding Number: Wu Jieping's Foundation Special for Clinical Research ) |
First Posted: | October 5, 2021 Key Record Dates |
Last Update Posted: | October 5, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | There is not a plan to make IPD available. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Laparoscopic Ultralow rectal cancer Intersphincteric resection |
Total mesorectal excision Transanterior obturator nerve gateway Distal rectal transection |
Rectal Neoplasms Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases |