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A Prospective, Interventional, Single-Center, Single-Arm, IDEAL Stage 2a Study on Bladder Flap Combined with Biological Mesh for Pelvic Floor Reconstruction in Pelvic Exenteration for Radiation-Induced Pelvic Fistula of Cervical Cancer to Prevent Empty Pelvis Syndrome

A Prospective, Interventional, Single-Center, Single-Arm, IDEAL Stage 2a Study on Bladder Flap Combined with Biological Mesh for Pelvic Floor Reconstruction in Pelvic Exenteration for Radiation-Induced Pelvic Fistula of Cervical Cancer to Prevent Empty Pelvis Syndrome

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113171
Enrollment
Unknown
Registered
2025-11-25
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Radiation-Induced Pelvic Fistula of Cervical Cancer

Interventions

Trial group:Resection of the trigone and partial bladder base lesions, partial pelvic segments of both ureters, vagina, cervix, uterus, cervix, bilateral adnexa, with or without rectal resection
remaining bladder wall with submucosal dissection combined with biological patch for pelvic floor reconstruction. The bladder flap must be sutured to the abdominal wall under appropriate tension
the area of the biological patch is selected according to intraoperative conditions.

Sponsors

The Sixth Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Previously diagnosed as a cervical cancer patient; 2. Previously received radiotherapy (regardless of whether radical resection of cervical cancer was performed or not); 3. Medical history and endoscopic examination confirm the presence of vesicovaginal fistula or vesicovaginal-rectal fistula caused by radiotherapy; 4. Informed consent obtained from the patient.

Exclusion criteria

Exclusion criteria: 1. Preoperative confirmation of primary or recurrent pelvic tumors, or distant metastatic malignant tumors; 2. Complications with other systemic diseases, such as cardiac, hepatic or renal insufficiency, coagulation dysfunction, etc.; 3. MDT concludes that the risk of undergoing pelvic exenteration (PE) surgery is relatively high; 4. Intraoperative exploration reveals that the bladder flap with normal tissue viability and blood supply is insufficient for pelvic floor reconstruction.

Design outcomes

Primary

MeasureTime frame
The incidence rate of postoperative empty pelvis syndrome;The Severity of Postoperative Empty Pelvis Syndrome;—

Secondary

MeasureTime frame
Postoperative Intrapelvic Cavity Volume;Operative Time;Estimated Intraoperative Blood Loss;Postoperative Hospital Stay;Postoperative Drainaging Time;Postoperative Non-EPS Complications and Their Severity in the Short Term (30 Days);—

Countries

China

Contacts

Public ContactQiu Jianguang

The Sixth Affiliated Hospital, Sun Yat-sen University

zhangty29@alumni.sysu.edu.cn+86 189 8892 2990

Outcome results

None listed

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