Evaluation on usefulness and safety of cysto-urethral anastomosis with additional ileal flap in patients with rectal cancer involving the prostate

Evaluation on usefulness and safety of cysto-urethral anastomosis with additional ileal flap in patients with rectal cancer involving the prostate - Ileal flap study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010530

Enrollment

Registered

2013-05-01

Start date

2013-04-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Lower rectal cancer involving the prostate

Interventions

Additional ileal flap operation in cysto-urethral anastomosis.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1.Male patients with locally advanced rectal cancer involving the prostate clinically. 2.Pathological proven adenocarcinoma. 3.Possible to be preservation of the sphincter urethrae. 4.With or Without anus-preservation. 5.No distant metastasis. 6.Normal length of the small intestine. 7.Aged 20 to 75 years old. 8.PS(ECOG) of 0 or 1. 9.Enough organ functions. WBC count : >=3000/mm3 Platelet count : >=70000/mm3 Hemoglobin : >=8.0g/dl T-Bil : <=1.5mg/dl AST : <=100IU/l ALT : <=100IU/l Cr : <=1.5mg/dl Alb : >=2.8g/dl 10. With or Without previous radiotherapy and chemotherapy. 11. Writhen informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with request of total pelvic exenteration (TPE), or patients without request of the ileal flap operation. 2. Impossible to be curative resection. 3. Patients with serious disease as follows. Uncontrollable diabetes mellitus(Hba1c >=8%) renal failure requiring artificial dialysis. requiring immunosuppressants 4. Patients with serious organ failure. 5. Cannot agree on this study. 6. Unsuitable patients for this study.

Design outcomes

Primary

Measure	Time frame
Cysto-urethral anastomotic leak rate at postoperative one month.	—

Secondary

Measure	Time frame
Rate of major leakage in cysto-urethral anastomosis. Healing term of CUA leakage. Safety of flap operation.	—

Countries

Japan

Contacts

Public ContactNorio Saito

National Cancer Center Hospital East Colorectal and Pelvic Surgery

norsaito@east.ncc.go.jp04-7133-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026