Completely Abdominal Approach Laparoscopic Partial Intersphincteric Resection for Rectal Cancer
Primary Purpose
Rectal Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lap partial ISR
NCRT+Lap partial ISR
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Biopsy-proven moderate or well differentiated adenocarcinoma
- Rullier classification of low rectal cancer (types Ⅱ: juxta-anal tumor)
- Clinical staging: initially staged as T1 -2 or down staged to T1-2 after neoadjuvant chemoradiotherapy;
Exclusion Criteria:
- Without signing informed consent, poor compliance
- Unfit for laparoscopy
- Other serious diseases not suitable for participating in this clinical trial
- A degree of preoperative fecal incontinence
- After preoperative neoadjuvant chemoradiotherapy, the sphincter function, sexual function and others involved in this trail are seriously affected
Sites / Locations
- Zhongnan Hospital, Wuhan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A group
B group
Arm Description
Patients who are initially staged as T1-2, according to MRI and intraluminal ultrasound, are assigned to the direct surgery group (determined by the multidisciplnary team [MDT] group)
Patients who are initially staged as T3M0, according to MRI and intraluminal ultrasound, should undertake preoperative chemoradiotherapy (determined by the MDT group). The operation was performed 8-12 weeks after the end of the chemoradiotherapy.
Outcomes
Primary Outcome Measures
The damage degree of anal function
The value of this index in group A was defined as the preoperative anal function score minus the postoperative anal score. The value of this index in group B was defined as the anal function score which the patients have completed the standard neoadjuvant therapy minus the postoperative anal function score.
Secondary Outcome Measures
Time for mobilizing the intersphincteric space
Time for mobilizing the intersphincteric space
The intactness of levator anus muscle fascia
The intactness of levator anus muscle fascia
he quality of specimen pathology: total mesorectal excision (TME) quality, the involvement of distal margin and circumferential margin
The quality of specimen pathology: total mesorectal excision (TME) quality, the involvement of distal margin and circumferential margin
Intraoperative and postoperative complications
Intraoperative and postoperative complications
Local recurrence
Local recurrence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04481659
Brief Title
Completely Abdominal Approach Laparoscopic Partial Intersphincteric Resection for Rectal Cancer
Official Title
Completely Abdominal Approach Laparoscopic Partial Intersphincteric Resection for Rectal Cancer: A Non-randomized, Prospective, Single-center Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 19, 2020 (Anticipated)
Primary Completion Date
July 19, 2025 (Anticipated)
Study Completion Date
July 19, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhongnan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The conventional intersphincteric resection (ISR) for low rectal cancer requires a combined abdominal and perineal approach, and followed with a handsewn coloanal anastomosis, which is time consuming and difficult to accomplish. A complete laparoscopic abdominal approach partial intersphincteric resection has been proved to be a safe and feasible alternative for low rectal cancer treatment, with the advantages of technical convenience and avoiding a permanent ostomy. But there are few reports concerning differences in clinical outcomes between patients with or without neoadjuvant chemoradiotherapy undergoing partial ISR surgery. Therefore, it is necessary to compare the functional outcomes (including anal and sexual function, and postoperative quality of life [QOL]) and oncologic outcomes of patients who underwent completely abdominal approach laparoscopic partial ISR surgery after neoadjuvant chemoradiotherapy, with those who received ISR surgery directly. Furthermore, the operation difficulty between the above two groups is also worthy of intensive study.
Detailed Description
Patients with cT1 to cT2 low rectal cancer are directly operated through completely abdominal approach laparoscopic partial ISR surgery. Patients with cT3 low rectal cancer are firstly treated with standard neoadjuvant chemoradiotherapy until down staged to ycT1 to ycT2. The postoperatively functional outcomes and oncologic outcomes between the two groups are compared, including anal and sexual function, QOL and local recurrence rate. The operation difficulty between the above two groups is also investigated, including operation time, the intraoperative and postoperative complications, mesorectum integrity, time for mobilizing the intersphincteric plane, the intactness of the fascia of the levator ani muscle, pubis coccygeus, puborectalis, and external sphincter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A group
Arm Type
Experimental
Arm Description
Patients who are initially staged as T1-2, according to MRI and intraluminal ultrasound, are assigned to the direct surgery group (determined by the multidisciplnary team [MDT] group)
Arm Title
B group
Arm Type
Experimental
Arm Description
Patients who are initially staged as T3M0, according to MRI and intraluminal ultrasound, should undertake preoperative chemoradiotherapy (determined by the MDT group). The operation was performed 8-12 weeks after the end of the chemoradiotherapy.
Intervention Type
Procedure
Intervention Name(s)
Lap partial ISR
Intervention Description
A direct laparoscopic surgery with completely abdominal approach laparoscopic partial intersphincteric resection
Intervention Type
Combination Product
Intervention Name(s)
NCRT+Lap partial ISR
Intervention Description
Preoperative radiation and chemotherapy + laparoscopic completely abdominal approach laparoscopic partial intersphincteric resection
Primary Outcome Measure Information:
Title
The damage degree of anal function
Description
The value of this index in group A was defined as the preoperative anal function score minus the postoperative anal score. The value of this index in group B was defined as the anal function score which the patients have completed the standard neoadjuvant therapy minus the postoperative anal function score.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Time for mobilizing the intersphincteric space
Description
Time for mobilizing the intersphincteric space
Time Frame
5 years
Title
The intactness of levator anus muscle fascia
Description
The intactness of levator anus muscle fascia
Time Frame
5 years
Title
he quality of specimen pathology: total mesorectal excision (TME) quality, the involvement of distal margin and circumferential margin
Description
The quality of specimen pathology: total mesorectal excision (TME) quality, the involvement of distal margin and circumferential margin
Time Frame
5 years
Title
Intraoperative and postoperative complications
Description
Intraoperative and postoperative complications
Time Frame
5 years
Title
Local recurrence
Description
Local recurrence
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Biopsy-proven moderate or well differentiated adenocarcinoma
Rullier classification of low rectal cancer (types Ⅱ: juxta-anal tumor)
Clinical staging: initially staged as T1 -2 or down staged to T1-2 after neoadjuvant chemoradiotherapy;
Exclusion Criteria:
Without signing informed consent, poor compliance
Unfit for laparoscopy
Other serious diseases not suitable for participating in this clinical trial
A degree of preoperative fecal incontinence
After preoperative neoadjuvant chemoradiotherapy, the sphincter function, sexual function and others involved in this trail are seriously affected
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qun Qian, M.D.
Phone
(+86)13517110773
Email
wb002554@whu.edu.cn
Facility Information:
Facility Name
Zhongnan Hospital, Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qun Qian, M.D.
Phone
(+86)13517110773
Email
wb002554@whu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Completely Abdominal Approach Laparoscopic Partial Intersphincteric Resection for Rectal Cancer
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