Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery
1 other identifier
interventional
172
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. PANP (pelvic autonomic nerve preservation) 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 (O-PANP-TME) or laparoscopic PANP TME surgery (L-PANP-TME). In the early stage of work, the investigators performed preservation of Denovilliers' fascia in L-PANP-TME to discuss the protection of urinary and sexual function of male mid-low rectal cancer patients. The results showed that preservation of Denovilliers' fascia in L-PANP-TME significantly decreased incidence of urinary and sexual function disorder. In order to further confirm the early work, the investigators design a randomized controlled clinical trial to compare differences in urinary and sexual function protection and long-term outcomes between preservation and excision of Denovilliers' fascia in L-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 Feb 2015
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
First Submitted
Initial submission to the registry
December 4, 2014
CompletedFirst Posted
Study publicly available on registry
December 8, 2014
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedJanuary 29, 2019
January 1, 2019
4.8 years
December 4, 2014
January 26, 2019
Conditions
Outcome Measures
Primary Outcomes (6)
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
3-year disease free survival rate
36 months
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 (8)
Morbidity
30 days
3-year overall survival rate
36 months
3-year recurrence pattern
36 months
Mortality
30 days
Morbidity
36 months
- +3 more secondary outcomes
Study Arms (2)
Preservation of Denonvilliers Fascia
EXPERIMENTALPreservation of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery for male mid-low rectal cancer patients
Excision of Denonvilliers Fascia
ACTIVE COMPARATORExcision of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery for male mid-low rectal cancer patients
Interventions
In this group, patients accepte L-PANP surgery without excision of Denonvilliers Fascia
In this group, patients accepte L-PANP surgery with excision of Denonvilliers Fascia
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 L-PANP;
- 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:
- 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)
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
- Assistant to the Dean
Study Record Dates
First Submitted
December 4, 2014
First Posted
December 8, 2014
Study Start
February 1, 2015
Primary Completion
December 1, 2019
Study Completion
April 1, 2020
Last Updated
January 29, 2019
Record last verified: 2019-01