Multicenter Study on Laparoscopic Versus Open PANP-TME for Male Mid-low Rectal Cancer Patients
Multicenter Study on Outcomes and Protection of Urinary and Sexual Function of Laparoscopic Versus Open PANP-TME for Male Mid-low Rectal Cancer Patients
1 other identifier
interventional
667
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 10, 2014
CompletedFirst Posted
Study publicly available on registry
June 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedApril 26, 2018
April 1, 2018
5.9 years
June 10, 2014
April 24, 2018
Conditions
Outcome Measures
Primary Outcomes (6)
3-year disease free survival rate
36 months
Urinary function
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
30 days
Sexual function
IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function
30 days
5-year disease free survival rate
60 months
Urinary function
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
36 months
Sexual function
IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function
36 months
Secondary Outcomes (6)
Morbidity
30 days
3-year overall survival rate
36 months
Mortality
30 days
Morbidity
36 months
Mortality
36 months
- +1 more secondary outcomes
Study Arms (2)
O-PANP-TME
ACTIVE COMPARATOROpen pelvic autonomic nerve preservation total mesorectum excision for male mid-low rectal cancer patients
L-PANP-TME
EXPERIMENTALLaparoscopy-assisted pelvic autonomic nerve preservation total mesorectum excision for male mid-low rectal cancer patients
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of surgery
Study Record Dates
First Submitted
June 10, 2014
First Posted
June 18, 2014
Study Start
January 1, 2014
Primary Completion
December 1, 2019
Study Completion
December 1, 2023
Last Updated
April 26, 2018
Record last verified: 2018-04