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A new suture method of ureteral skin stoma (flap embedding method): a open-label, single-arm phase I trial

A new suture method of ureteral skin stoma (flap embedding method): a open-label, single-arm phase I trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073003
Enrollment
Unknown
Registered
2023-06-29
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-09-26

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

Conditions

bladder cancer

Interventions

Experimental group:Ureteral skin stoma using flap embedding method

Sponsors

Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients over 18 years old; 2. MIBC or high-risk and extremely high-risk NMIBC confirmed by cystoscopy and pathological biopsy before operation, including: (1) Recurrent or multiple high-grade tumors; (2) High-grade tumors with carcinoma in situ; (3) Tumors with ineffective BCG treatment; (4) Extensive papillary lesions beyond the control of TUR and intravesical instillation; (5) Non-urothelial bladder cancer; (6) Urothelial carcinoma with poor histological variant subtypes; 3. Imaging examination showed that there was no tumor in the renal pelvis and upper ureter; 4. Sign the informed consent form for clinical trials.

Exclusion criteria

Exclusion criteria: 1. Unwilling to sign informed consent; 2. Preoperative cystoscopic biopsy confirmed benign tumor; 3. Unable to understand the research process, postoperative unwilling to accept follow-up; 4. Distant metastasis; 5. Combined with upper urinary tract malignant tumor; 6. Simultaneous nephrectomy and ureterectomy; 7. Combined with heart, liver, kidney and other organ dysfunction.

Design outcomes

Primary

MeasureTime frame
hydronephrosis;Narrow stoma;Glomerular filtration rate, GFR;Serum creatinine;calculus of the ureter;calculus of the ureter;Cys-C;

Secondary

MeasureTime frame
operation time;blood loss;infection of stoma;Stomal necrosis;

Countries

China

Contacts

Public ContactChuanliang Xu

Changhai Hospital

chuanliang_xu@126.com+86 21 3116 6666

Outcome results

None listed

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