Ignite Creation Date:
2024-05-06 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05067413
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2021-10-05
First Post:
2021-08-25
Brief Title:
A Study on the Efficacy of a Novel Approach to Achieving Laparoscopic Distal Rectal Transection for Rectal Cancers
Sponsor:
Peking University First Hospital
Organization:
Peking University First Hospital
Study Overview
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 12021
Neoadjuvant chemoradiotherapy Pelvis radiotherapy with a total dose of 50 Gy with 25 courses in 5 weeks Neoadjuvant chemotherapy include single drug therapy capecitabine CAP 1250 mgm2 BID or double drug therapy oxaliplatin combined with capecitabine CapeOX oxaliplatin 130 mgm2 day 1 capecitabine 1000mg m2 day 1 14 then rest for 7 days repeated every 3 weeks or three-drug therapy mFOLFOX6 oxaliplatin 85 mg m2 intravenous infusion for 2 hours leucovorin calcium 400 mgm2 intravenous infusion for 2 hours 5-FU fluorouracil 400 mgm2 intravenous infusion for 1 day Then 1200 mg m2d2 days of continuous intravenous infusion with a total of 2400mgm2 for 46 48 hours repeated every 2 weeks
Abdominal and pelvic MRI and contrast enhanced CT will be routinely performed 6 to 8 weeks after neoadjuvant therapy to confirm the extent of tumor regression without new-found distant metastasis Those whose clinical stage after neoadjuvant therapy changes from T4 to T3 will be seen as eligible in this study
Surgical treatment Preoperative preparation
1 Patients older than 60 years old or having a smoking history for over 10 years will receive lung ventilation training and atomization treatment for 3 days 2 Intestinal preparation will be done with oral cathartic medications 12-24 hours before surgery 3 Prophylactic antibiotics will be given once anesthesia is begun the second antibiotics will be given if the operation lasts for over 3 hours 4Urethral catheterization will be routinely done preoperatively 5If the patient refuses to accept the novel approach before surgery they will be directly enrolled in the traditional group If both approaches are acceptable to the patient the decision whether to use the novel approach will be made according to the intraoperative conditions see operating procedures below
Operating procedures General anesthesia Modified lithotomy position Establishment of pneumoperitoneum Place a trocar 1cm above the umbilicus through which to establish pneumoperitoneum and keep the abdominal pressure as 12mmHg millimeters of mercury
Trocar placement above the umbilicus trocar C 10 mm upper right and left quadrants trocars B and D 5 mm lower right quadrant trocar A 12 mm lower left quadrant trocar E 5 mm the midpoint between the pubic symphysis and umbilicus trocar F 5 mm
Abdominal exploration Explore the abdominal cavity in accordance with the principle of non-contact from far to near step by step explore the tumor finally
The mesosigmoid and mesorectum are dissected from the right lateral rectum towards the root of the inferior mesenteric artery IMA The IMA is transected and ligated so is the inferior mesenteric vein Posterior space of the descending colon is dissected following opening the peritoneum beside the left rectum The rectum in the pelvis is been mobilized from posterior rectal space anterior rectal space to bilateral rectal space successively The lower edge of the tumor is marked by a clamp The linear stapler is placed in the pelvis to clamp the distal rectum below the tumor to see if the transection can be done more than 1cm from the lower edge of the tumor If yes the distal rectum will be transected by the traditional approach that means the patient will be assigned to the traditional group The proximal bowel is transected through a small midline incision Then the coloanal anastomosis will be done intracorporeally A surgical drain is placed in the pelvis and a terminal ileostomy is routinely performed All incisions are closed
If the distal rectal transection cannot be done more than 1cm from the lower edge of the tumor the anterior obturator nerve gateway approach will be used that means the patient will be assigned to the experimental group The steps are as follows The peritoneum covering the ureter and external iliac artery is opened more than 2 cm across the vas deferens male or round ligament female The Retzius space and vesicohypogastric fascia are exposed The obturator vessels and obturator nerve are properly identified Care should be taken to avoid any injury when using energy devices near the obturator nerve The gateway is then opened through the TME total mesorectal excision compartment and the lateral compartment If necessary an endoloop can be placed through the gateway and the bundled S2-4 nerves ureter and bladder vessels are gently retracted toward the cranial direction to widen the gap The linear stapler is placed in the gateway to vertically transect the distal rectum The following procedures are the same with the traditional group as described above
During the operation the following variables will be recorded the angle between the linear stapler and the rectum distance from the lower edge to the resecting margin whether the operation converted to transanal approach operative time bleeding volume anastomotic height from anal verge and the length of the stapling line
Postoperative management
The following information will be recorded
1Vital signs body temperature pulse rate respiration rate blood pressure are routinely monitored gross volume of fluid input and output will be recorded every 24h blood routine the comprehensive metabolic panel and coagulation function tests will be performed every 3 days 2The time of catheter removal days after operation residual urine volume in the bladder will be measured by ultrasound examination Whether there is a request to be re-catheterized or take oral medication to relive the dysuria All patients will be asked to fulfil the IPSS International prostate symptom score questionnaire to assess urinary function 3The time of pelvic drain removal days after operation 4Whether complicated with anastomotic leakage ileus and long-lasting more than 5 days pulmonary or abdominal infection 5All information of the pathologic report 6Postoperative hospital stay days Postoperative chemoradiotherapy Radiotherapy program is the same with the neoadjuvant therapy Chemotherapy will be advised for patients with stage II cancer accompanied with the following high-risk factors histologically poorly differentiated with normal mismatched repair or stable microsatellite MSS pT4 pathological stage T 4 vascularnerve invasion preoperative intestinal obstruction or perforation 12 lymph nodes retrieved and R1 resection The chemotherapy program is the same with neoadjuvant chemotherapy If mismatch repair defect dMMR or high-level microsatellite instability MSI-H is confirmed by pathology chemotherapy will not be advised Patients with stage III cancer will routinely receive chemotherapy
Follow-up
1 Information on general medical history and physical examination will be collected every 3 months for 3 years 2 Blood tumor markers of CEA carcinoembryonic antigen and CA19-9 carbohydrate antigen 19-9 will be tested every 3 months for 3 years 3 Abdominal and pelvic ultrasound and chest X-ray examinations will be carried out every 3 months for 3 years 4 Abdominal and pelvic MRI or contrast enhanced CT scan will be done every year for 3 years 5 Colonoscopy will be performed within 1 year after surgery If there is any abnormity reexamination will be required within half a year If no abnormality is found once a year for 3 years All new-found adenomas by the colonoscopy during follow-up are recommended to be resected 6 Sexual function score is assessed by filling in the questionnaire IIEF-5 both preoperatively and 1 year later since operation 7 3-year tumor-free survival month The time from operation to confirmation of tumors local recurrence or distant metastasis The end point of the patient lost to follow-up is the date of loss 30 days is defined as one month 8 3-year overall survival month The time from operation to death The end point of the patient lost to follow-up is the date of loss 30 days is defined as one month 9 Stoma closure time months since operation Anal function is assessed by Wexner scale 3 months and 12 months after stoma closure respectively
As to possible risks and benefits of participating in this trial see details in the informed consent document Study start date actual 2020-12-01 Study completion date anticipated 2025-12-01 All outcomes of the last patient are recorded 3 years postoperatively death or loss to follow-up of the last patient Statistics IBM SPSS Statistical Package for the Social Sciences Statistics 25 IBM Inc Armonk NY will be used to perform statistical analyses The t test and Mann-Whitney U test were used for quantitative data between groups Qualitative data were compared by Chi-square test or Fishers exact test and survival distributions were analyzed by log-rank test
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 12021
Neoadjuvant chemoradiotherapy Pelvis radiotherapy with a total dose of 50 Gy with 25 courses in 5 weeks Neoadjuvant chemotherapy include single drug therapy capecitabine CAP 1250 mgm2 BID or double drug therapy oxaliplatin combined with capecitabine CapeOX oxaliplatin 130 mgm2 day 1 capecitabine 1000mg m2 day 1 14 then rest for 7 days repeated every 3 weeks or three-drug therapy mFOLFOX6 oxaliplatin 85 mg m2 intravenous infusion for 2 hours leucovorin calcium 400 mgm2 intravenous infusion for 2 hours 5-FU fluorouracil 400 mgm2 intravenous infusion for 1 day Then 1200 mg m2d2 days of continuous intravenous infusion with a total of 2400mgm2 for 46 48 hours repeated every 2 weeks
Abdominal and pelvic MRI and contrast enhanced CT will be routinely performed 6 to 8 weeks after neoadjuvant therapy to confirm the extent of tumor regression without new-found distant metastasis Those whose clinical stage after neoadjuvant therapy changes from T4 to T3 will be seen as eligible in this study
Surgical treatment Preoperative preparation
1 Patients older than 60 years old or having a smoking history for over 10 years will receive lung ventilation training and atomization treatment for 3 days 2 Intestinal preparation will be done with oral cathartic medications 12-24 hours before surgery 3 Prophylactic antibiotics will be given once anesthesia is begun the second antibiotics will be given if the operation lasts for over 3 hours 4Urethral catheterization will be routinely done preoperatively 5If the patient refuses to accept the novel approach before surgery they will be directly enrolled in the traditional group If both approaches are acceptable to the patient the decision whether to use the novel approach will be made according to the intraoperative conditions see operating procedures below
Operating procedures General anesthesia Modified lithotomy position Establishment of pneumoperitoneum Place a trocar 1cm above the umbilicus through which to establish pneumoperitoneum and keep the abdominal pressure as 12mmHg millimeters of mercury
Trocar placement above the umbilicus trocar C 10 mm upper right and left quadrants trocars B and D 5 mm lower right quadrant trocar A 12 mm lower left quadrant trocar E 5 mm the midpoint between the pubic symphysis and umbilicus trocar F 5 mm
Abdominal exploration Explore the abdominal cavity in accordance with the principle of non-contact from far to near step by step explore the tumor finally
The mesosigmoid and mesorectum are dissected from the right lateral rectum towards the root of the inferior mesenteric artery IMA The IMA is transected and ligated so is the inferior mesenteric vein Posterior space of the descending colon is dissected following opening the peritoneum beside the left rectum The rectum in the pelvis is been mobilized from posterior rectal space anterior rectal space to bilateral rectal space successively The lower edge of the tumor is marked by a clamp The linear stapler is placed in the pelvis to clamp the distal rectum below the tumor to see if the transection can be done more than 1cm from the lower edge of the tumor If yes the distal rectum will be transected by the traditional approach that means the patient will be assigned to the traditional group The proximal bowel is transected through a small midline incision Then the coloanal anastomosis will be done intracorporeally A surgical drain is placed in the pelvis and a terminal ileostomy is routinely performed All incisions are closed
If the distal rectal transection cannot be done more than 1cm from the lower edge of the tumor the anterior obturator nerve gateway approach will be used that means the patient will be assigned to the experimental group The steps are as follows The peritoneum covering the ureter and external iliac artery is opened more than 2 cm across the vas deferens male or round ligament female The Retzius space and vesicohypogastric fascia are exposed The obturator vessels and obturator nerve are properly identified Care should be taken to avoid any injury when using energy devices near the obturator nerve The gateway is then opened through the TME total mesorectal excision compartment and the lateral compartment If necessary an endoloop can be placed through the gateway and the bundled S2-4 nerves ureter and bladder vessels are gently retracted toward the cranial direction to widen the gap The linear stapler is placed in the gateway to vertically transect the distal rectum The following procedures are the same with the traditional group as described above
During the operation the following variables will be recorded the angle between the linear stapler and the rectum distance from the lower edge to the resecting margin whether the operation converted to transanal approach operative time bleeding volume anastomotic height from anal verge and the length of the stapling line
Postoperative management
The following information will be recorded
1Vital signs body temperature pulse rate respiration rate blood pressure are routinely monitored gross volume of fluid input and output will be recorded every 24h blood routine the comprehensive metabolic panel and coagulation function tests will be performed every 3 days 2The time of catheter removal days after operation residual urine volume in the bladder will be measured by ultrasound examination Whether there is a request to be re-catheterized or take oral medication to relive the dysuria All patients will be asked to fulfil the IPSS International prostate symptom score questionnaire to assess urinary function 3The time of pelvic drain removal days after operation 4Whether complicated with anastomotic leakage ileus and long-lasting more than 5 days pulmonary or abdominal infection 5All information of the pathologic report 6Postoperative hospital stay days Postoperative chemoradiotherapy Radiotherapy program is the same with the neoadjuvant therapy Chemotherapy will be advised for patients with stage II cancer accompanied with the following high-risk factors histologically poorly differentiated with normal mismatched repair or stable microsatellite MSS pT4 pathological stage T 4 vascularnerve invasion preoperative intestinal obstruction or perforation 12 lymph nodes retrieved and R1 resection The chemotherapy program is the same with neoadjuvant chemotherapy If mismatch repair defect dMMR or high-level microsatellite instability MSI-H is confirmed by pathology chemotherapy will not be advised Patients with stage III cancer will routinely receive chemotherapy
Follow-up
1 Information on general medical history and physical examination will be collected every 3 months for 3 years 2 Blood tumor markers of CEA carcinoembryonic antigen and CA19-9 carbohydrate antigen 19-9 will be tested every 3 months for 3 years 3 Abdominal and pelvic ultrasound and chest X-ray examinations will be carried out every 3 months for 3 years 4 Abdominal and pelvic MRI or contrast enhanced CT scan will be done every year for 3 years 5 Colonoscopy will be performed within 1 year after surgery If there is any abnormity reexamination will be required within half a year If no abnormality is found once a year for 3 years All new-found adenomas by the colonoscopy during follow-up are recommended to be resected 6 Sexual function score is assessed by filling in the questionnaire IIEF-5 both preoperatively and 1 year later since operation 7 3-year tumor-free survival month The time from operation to confirmation of tumors local recurrence or distant metastasis The end point of the patient lost to follow-up is the date of loss 30 days is defined as one month 8 3-year overall survival month The time from operation to death The end point of the patient lost to follow-up is the date of loss 30 days is defined as one month 9 Stoma closure time months since operation Anal function is assessed by Wexner scale 3 months and 12 months after stoma closure respectively
As to possible risks and benefits of participating in this trial see details in the informed consent document Study start date actual 2020-12-01 Study completion date anticipated 2025-12-01 All outcomes of the last patient are recorded 3 years postoperatively death or loss to follow-up of the last patient Statistics IBM SPSS Statistical Package for the Social Sciences Statistics 25 IBM Inc Armonk NY will be used to perform statistical analyses The t test and Mann-Whitney U test were used for quantitative data between groups Qualitative data were compared by Chi-square test or Fishers exact test and survival distributions were analyzed by log-rank test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 32067502021-04-2 | OTHER_GRANT | Wu Jiepings Foundation Special for Clinical Research | None |