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Single-center, single-arm study on the protection of male sexual function and urination function by laparoscopic autonomic nerve preservation surgery for rectal cancer

Single-center, single-arm study on the protection of male sexual function and urination function by laparoscopic autonomic nerve preservation surgery for rectal cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900024364
Enrollment
Unknown
Registered
2019-07-07
Start date
2019-07-15
Completion date
Unknown
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rectal cancer

Interventions

autonomic nerve preservation group:Laparoscopic radical rectal surgery, autonomic nerve preservation

Sponsors

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1 Aged 20 to 70 years, male patient, informed consent; 2 The primary rectal lesion was diagnosed as rectal adenocarcinoma by endoscopic biopsy histopathology. 3 The distance between the tumor and the anal border should be less than 20cm (comprehensive evaluation by digital rectal examination, colonoscopy and imaging examination). 4 Preoperative staging was T1-3N0-1M0 (according to ajcc-8thtnm tumor staging). 5 Total mesorectal resection is expected to yield R0 results (multiple primary cancers are also applicable). 6 Preoperative ECOG physical state score was 0-1. 7 Preoperative urination function of the patients was normal (iPSS = 15ml/ SEC, bladder residual urine 21, ejaculation function grade I)

Exclusion criteria

Exclusion criteria: 1 Patients with tumor complicated with acute intestinal obstruction, perforation or bleeding; 2 Large tumor or extensive invasion of surrounding tissues and organs, TME is not available; 3 Preoperative imaging examination suggested regional fusion of enlarged lymph nodes (maximum diameter >= 3cm); 4 Other malignant diseases or other malignant diseases within 5 years; 5 With a history of large and medium operation in the lower abdomen and pelvic cavity, it is not suitable for laparoscopic surgery. 6 Suffering from severe mental illness; 7 Heart, brain, lung and other important organs are not functional enough to tolerate surgery; 8 A history of unstable angina pectoris or myocardial infarction within 6 months, or a history of cerebral infarction or cerebral hemorrhage; 9 A history of continuous systemic corticosteroids or immunosuppressive drugs within 1 month; 10 Patients with true incontinence or severe stress incontinence before surgery.

Design outcomes

Primary

MeasureTime frame
Incidence of sexual dysfunction 6 months after surgery;

Secondary

MeasureTime frame
Incidence of urinary dysfunction 6 months after surgery;circumferential resection margin;mortality and morbidity;

Countries

China

Contacts

Public ContactHan Fanghai

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

fh_han@163.com+86 13580317677

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026