Rectal Cancer
Conditions
Keywords
Rectal Cancer, Nerve plane, Sexual dysfunction, Urinary dysfunction, Total mesorectal excision
Brief summary
Urinary and sexual dysfunctions are among the most common complications in rectal cancer surgery. The aim of this study was to investigate the protective effect of laparoscopic functional total mesorectum excision (FTME) on urinary and sexual function in male patients with mid-low rectal cancer. This is a prospective, single-arm, multicenter, uncontrolled, clinical study in 88 eligible subjects with mid-low rectal cancer. After informed consent, eligible patients will be performed laparoscopic FTME surgery. Patients' demographic, operative detail, postoperative outcomes and follow-up will be recorded prospectively.
Detailed description
Previously, our studies have demonstrated the presence of nerve plane in laparoscopic rectal cancer surgery, which was the overlying tiny membranous tissue including the nerves, the adipose tissue, and the extremely tiny capillaries around the nerve. As a consequence, the concept of nerve plane-oriented functional total mesorectal excision (FTME) was proposed as an optimal surgical procedure about pelvic autonomic nerve preservation in rectal cancer surgery. Following the TME principles, the surgical procedure of FTME was guided by the nerve plane and dissected between the proper fascia of the rectum and nerve plane (the first gap), which could ensure completeness of the nerve plane and the proper fascia of the rectum. This surgical procedure not only ensures radical resection but also protects PAN better, and the investigators also showed the difference between routine TME and FTME in our previous study, which included inferior mesenteric plexus preservation, station 253 nodes dissection, existence of the first gap, Waldeyer's fascia and Denonvillier's fascia (DVF) preservation, neurovascular bundles preservation, and completeness of mesorectum and nerve plane. Currently, it was a lack of higher-level evidence-based evidence to confirm the protective effect of laparoscopic FTME on urinary and sexual function in male patients with mid-low rectal cancer. In the present study, the investigators performed the prospective, single-arm, multicenter, uncontrolled clinical study, eligible patients will be performed laparoscopic FTME surgery. Postoperative sexual function, urinary function, complications, quality of life, recurrence rate, recurrence patterns, disease-free survival, and overall survival will be recorded prospectively. The results of the patients will be assessed to validate postoperative functional outcomes and oncologic outcomes of laparoscopic FTME surgery.
Interventions
PROCEDURELaparoscopic FTME surgery
Nerve plane was defined as the overlying tiny membranous tissue including the nerves, the adipose tissue and the extremely tiny capillaries around the nerve. Following the TME principles, the surgical procedure of FTME was guided by the nerve plane and dissected between the proper fascia of the rectum and nerve plane (the first gap), which could ensure completeness of the nerve plane and the proper fascia of the rectum.
Sponsors
Renmin Hospital of Wuhan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Male, 18-70 years of age, informed consent; 2. Tumors from anal edge 6 \ 12 cm (measured by rigid proctoscope); 3. Rectal cancer confirmed pathologically by endoscopic biopsy; 4. Preoperative cT1-3aN0M0 stage (ESMO, 2013); 5. Ro resection is expected; 6. Normal urinary function, normal erection function and ejaculation function grading as I level;
Exclusion criteria
1. History of abdominal and pelvic major surgery; 2. Emergency surgery is needed due to the complication (bleeding, obstruction, or perforation) caused by rectal cancer; 3. Pelvic or distant metastasis; 4. Neoadjuvant radiotherapy or chemoradiotherapy; 5. No sexual life;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of sexual dysfunction | 6 months | The 5-item version of the International Index of Erectile Function (IIEF-5) and ejaculation function are used to assess sexual function. the IIEF-5 total score ranged from 1 to 25, with a lower score indicating more severe erectile dysfunction, male sexual dysfunction was defined as the IIEF-5 score ≤11points. Ejaculation function was classified as: Grade I, normal ejaculation; Grade II: retrograde ejaculation; Grade III: anejaculation, and ejaculation dysfunction was identified as ejaculation function of grade II/III. |
| Incidence of urinary dysfunction | 3 months | The International Prostate Symptom Score (IPSS) are used to assess urinary function. the IIEF-5 total score ranged from 0 to 35, with a higher score indicating more severe erectile dysfunction,moderate-to-severe urinary dysfunction was defined as the IPSS score \>8 points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year overall survival rate | 36 months | 3-year overall survival rate |
| 3-year disease free survival rate | 36 months | 3-year disease free survival rate |
| 5-year overall survival rate | 60 months | 5-year overall survival rate |
| Morbidity | 30 days | incidence of postoperatvie complications |
| Incidence of sexual dysfunction | 12 months | The 5-item version of the International Index of Erectile Function (IIEF-5) and ejaculation function are used to assess sexual function. the IIEF-5 total score ranged from 1 to 25, with a lower score indicating more severe erectile dysfunction, male sexual dysfunction was defined as the IIEF-5 score ≤11points. Ejaculation function was classified as: Grade I, normal ejaculation; Grade II: retrograde ejaculation; Grade III: anejaculation, and ejaculation dysfunction was identified as ejaculation function of grade II/III. |
| Incidence of urinary dysfunction | 6 months | The International Prostate Symptom Score (IPSS) are used to assess urinary function. the IIEF-5 total score ranged from 0 to 35, with a higher score indicating more severe erectile dysfunction,moderate-to-severe urinary dysfunction was defined as the IPSS score \>8 points. |
| 5-year disease free survival rate | 60 months | 5-year disease free survival rate |
| Mortality | 30 days | incidence of postoperatvie deaths |
Countries
China
Contacts
Primary ContactYongbin Zheng, M.D,Ph.D
Outcome results
None listed