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A prospective randomized controlled trial for the prevention of radiation proctopathy in advanced cervical cancer by laparoscopic omentum vaginal and rectal diaphragm filling

A prospective randomized controlled trial for the prevention of radiation proctopathy in advanced cervical cancer by laparoscopic omentum vaginal and rectal diaphragm filling

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900028132
Enrollment
Unknown
Registered
2019-12-13
Start date
2019-12-15
Completion date
Unknown
Last updated
2019-12-16

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

Conditions

radiation proctopathy

Interventions

A:Laparoscopic omentum filling
B:pelvic radiotherapy

Sponsors

The First Affiliated Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Primary cervical adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma was confirmed by pathology; 2. Patients with stage IIB to stage IV clinical staging . 3. The patients had good hematopoiesis and hepatorenal function: leukocyte > 4 x 10^9 / L; platelet > 100 x 10^9 / L; creatinine < 2.0 mg / dl; bilirubin < 1.5 times of normal value; glutamic pyruvate transaminase and glutamic oxaloacetate transaminase < 3 times of normal value; 4. Patients can tolerate surgery in general; 5. Patients sign informed consent; 6. Patients with a history of cancer but no evidence of recurrence for more than 5 years can be selected; 7. Female patients aged 18 and above.

Exclusion criteria

Exclusion criteria: 1. Any pathological type other than adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma; 2. FIGO stage is from IA1 to iia2; 3. The patient has a history of pelvic or abdominal radiotherapy; 4. The subjects had a history of inflammatory bowel disease or colorectal surgery; 5. Pregnancy; 6. Not suitable for operation: serious systemic diseases are not suitable for this study; 7. Poor compliance or inability to follow up due to geographical factors.

Design outcomes

Primary

MeasureTime frame
Incidence of radiation proctopathy;

Countries

China

Contacts

Public ContactHuang Jiaming

The First Affiliated Hospital of Sun Yat-Sen University

jmshrek@163.com+86 13570338429

Outcome results

None listed

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