Multicenter Study on Laparoscopic Versus Open PANP-TME for Male Mid-low Rectal Cancer Patients
Primary Purpose
Rectum Neoplasms
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
L-PANP-TME
O-PANP-TME
Sponsored by
About this trial
This is an interventional treatment trial for Rectum Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Age from over 20 to under 60 years
- Primary rectal adenocarcinoma confirmed pathologically by endoscopic biopsy
- Mid-low rectal cancer (distance from anal edge≤12cm); cT1-3, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition
- Expected curative resection through both L-PANP-TME and O-PANP-TME; Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) score class I, II, or III; Written informed consent
- Urinary and sexual function normal preoperatively
Exclusion Criteria:
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous pelvic surgery
- Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
- History of other malignant disease within past five years
- History of unstable angina or myocardial infarction within past six months
- History of cerebrovascular accident within past six months
- History of continuous systematic administration of corticosteroids within one month
- Contraindication of heart, brain, lung, etc dysfunction
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by rectal cancer
- Rectal cancer invades surrounding tissues
- Existence of genuine incontinence or severe stress incontinence preoperatively
Sites / Locations
- The Third Affiliated Hospital of Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
O-PANP-TME
L-PANP-TME
Arm Description
Open pelvic autonomic nerve preservation total mesorectum excision for male mid-low rectal cancer patients
Laparoscopy-assisted pelvic autonomic nerve preservation total mesorectum excision for male mid-low rectal cancer patients
Outcomes
Primary Outcome Measures
3-year disease free survival rate
Urinary function
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
Sexual function
IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function
5-year disease free survival rate
Urinary function
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
Sexual function
IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function
Secondary Outcome Measures
Morbidity
3-year overall survival rate
Mortality
Morbidity
Mortality
5-year overall survival rate
Full Information
NCT ID
NCT02165800
First Posted
June 10, 2014
Last Updated
April 24, 2018
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Collaborators
First Affiliated Hospital, Sun Yat-Sen University, Sixth Affiliated Hospital, Sun Yat-sen University, Nanfang Hospital, Southern Medical University, Southern Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT02165800
Brief Title
Multicenter Study on Laparoscopic Versus Open PANP-TME for Male Mid-low Rectal Cancer Patients
Official Title
Multicenter Study on Outcomes and Protection of Urinary and Sexual Function of Laparoscopic Versus Open PANP-TME for Male Mid-low Rectal Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Recruiting
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Collaborators
First Affiliated Hospital, Sun Yat-Sen University, Sixth Affiliated Hospital, Sun Yat-sen University, Nanfang Hospital, Southern Medical University, Southern Medical University, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
TME (Total mesorectum excision) is the golden standard of radical resection for mid-low rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle will lead to high incidence of urinary and sexual function disorder. Open PANP (pelvic autonomic nerve preservation) TME surgery played a role in decreasing incidence of urinary and sexual function disorder. However, 32%-44% patients still suffered from urinary and sexual function disorder when underwent Open PANP TME surgery (O-PANP-TME).
Laparoscopy-assisted TME surgery (L-TME) is applied wildly nowadays. In the early stage of work, we performed laparoscopy-assisted PANP TME surgery (L-PANP-TME) to discuss the protection of urinary and sexual function of male mid-low rectal cancer patients. The results showed that L-PANP-TME significantly decreased incidence of urinary and sexual function disorder. In order to further confirm our early work, we design a multiple-center randomized controlled clinical trial to compare differences in urinary and sexual function protection and long-term outcomes between L-PANP-TME and O-PANP-TME.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectum Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
667 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
O-PANP-TME
Arm Type
Active Comparator
Arm Description
Open pelvic autonomic nerve preservation total mesorectum excision for male mid-low rectal cancer patients
Arm Title
L-PANP-TME
Arm Type
Experimental
Arm Description
Laparoscopy-assisted pelvic autonomic nerve preservation total mesorectum excision for male mid-low rectal cancer patients
Intervention Type
Procedure
Intervention Name(s)
L-PANP-TME
Intervention Type
Procedure
Intervention Name(s)
O-PANP-TME
Primary Outcome Measure Information:
Title
3-year disease free survival rate
Time Frame
36 months
Title
Urinary function
Description
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
Time Frame
30 days
Title
Sexual function
Description
IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function
Time Frame
30 days
Title
5-year disease free survival rate
Time Frame
60 months
Title
Urinary function
Description
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
Time Frame
36 months
Title
Sexual function
Description
IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Morbidity
Time Frame
30 days
Title
3-year overall survival rate
Time Frame
36 months
Title
Mortality
Time Frame
30 days
Title
Morbidity
Time Frame
36 months
Title
Mortality
Time Frame
36 months
Title
5-year overall survival rate
Time Frame
60 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age from over 20 to under 60 years
Primary rectal adenocarcinoma confirmed pathologically by endoscopic biopsy
Mid-low rectal cancer (distance from anal edge≤12cm); cT1-3, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition
Expected curative resection through both L-PANP-TME and O-PANP-TME; Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
ASA (American Society of Anesthesiology) score class I, II, or III; Written informed consent
Urinary and sexual function normal preoperatively
Exclusion Criteria:
Women during pregnancy or breast-feeding
Severe mental disorder
History of previous pelvic surgery
Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
History of other malignant disease within past five years
History of unstable angina or myocardial infarction within past six months
History of cerebrovascular accident within past six months
History of continuous systematic administration of corticosteroids within one month
Contraindication of heart, brain, lung, etc dysfunction
Requirement of simultaneous surgery for other disease
Emergency surgery due to complication (bleeding, obstruction or perforation) caused by rectal cancer
Rectal cancer invades surrounding tissues
Existence of genuine incontinence or severe stress incontinence preoperatively
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongbo Wei, M.D,Ph.D.
Phone
+86-189-2210-2969
Email
drweihb@126.com
Facility Information:
Facility Name
The Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongbo Wei, M.D., Ph.D.
12. IPD Sharing Statement
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Multicenter Study on Laparoscopic Versus Open PANP-TME for Male Mid-low Rectal Cancer Patients
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