A prospective feasibility study on the prevention of rectovaginal fistula after resection of low rectal carcinoma by anterior rectal anastomosis with fat flap with ovarian vascularized flap

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000031449

Enrollment

Unknown

Registered

2020-04-01

Start date

2020-04-05

Completion date

Unknown

Last updated

2020-04-06

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

Conditions

Rectovaginal fistula after surgery of low rectal carcinoma

Interventions

experimental group:D3 radical operation for rectal cancer and free fat with ovarian vascular pedicle

control group:D3 radical operation for rectal cancer

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-75 years; 2. Female, postmenopausal patients without ovarian function after radiotherapy and chemotherapy (serum FSH > 40u / L, LH > 20iu / L, and E2 < 10-20pg / ml) 3. Patients with definite diagnosis of rectal cancer. The ctnm stage is t3-4nxm0, 4. For the patients who received neoadjuvant radiotherapy and chemotherapy before operation, the chemotherapy schemes were fluorouracil based systemic chemotherapy schemes, and the radiotherapy schemes were long-term and small dose schemes; 5. Patients with tumor distance <= 7 cm from anal margin before operation; 6. Body mass index 18-30kg / m2; 7. Patients without primary malignant tumor in other parts; 8. Patients with complete clinical data and acceptable prophylactic ileostomy; 9. Patients willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with previous major abdominal operation history; 2. Patients in emergency operation (perforation, bleeding, intestinal obstruction, etc.); 3. Patients with severe heart, lung, liver and kidney diseases who cannot tolerate endoscopic surgery; 4. Patients with poor general conditions who can not be corrected and improved after preoperative treatment; 5. Patients with coagulation dysfunction; 6. Patients with poor general conditions who can not be corrected and improved after preoperative treatment; 7. Young women with functional ovaries; 8. Patients after hysterectomy and oophorectomy.

Design outcomes

Primary

Measure	Time frame
Incidence of rectovaginal fistula;	—

Countries

China

Contacts

Public ContactYing Huang

Union Hospital Affiliated to Fujian Medical University

bettyfj@163.com+86 13365910923

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026