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A prospective clinical study the PE Bacon in the treatment of late complications of chronic radiation proctitis

A prospective clinical study the PE Bacon in the treatment of late complications of chronic radiation proctitis

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033168
Enrollment
Unknown
Registered
2020-05-22
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

Late Complication of Chronic Radiation Proctitis

Interventions

Case series:PE-Bacon surgery

Sponsors

Sixth Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-70 years; 2. Patients with ECoG physical condition score of 0-2; 3. Patients with previous pathological diagnosis of pelvic tumors (Gynecology, prostate, urinary system); 4. Patients with a history of pelvic radiotherapy, at least 6 months from the end of the last radiotherapy; 5. Patients without recurrence or metastasis of primary tumor; 6. The late complications of CRP patients, such as deep rectal ulcer (VRS score >=3), rectal sigmoid colon stenosis, obstruction, chronic perforation, rectal necrosis, rectovaginal fistula, intractable anal pain caused by rectal lesions, intractable rectal bleeding which is still difficult to be relieved by stoma operation, and patients who need sigmoid colorectal resection; 7. Patients who can tolerate general anesthesia; 8. The subjects and their families are able to understand the study plan, willing to participate and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with acute intestinal obstruction, acute intestinal perforation and intestinal hemorrhage who need emergency operation; 2. Patients with severe pelvic adhesion and frozen pelvis; 3. Patients with unstable primary tumor or tumor in other parts; 4. Patients who need to undergo combined organ resection; 5. Patients with a history of sigmoidostomy; 6. ASA level IV to V; 7. Patients with serious mental illness; 8. Pregnant or lactating women; 9. Patients with serious cardiovascular disease, uncontrollable infection, or other uncontrollable combined diseases.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative anastomotic leakage;

Secondary

MeasureTime frame
Incidence of postoperative anastomotic stenosis;Incidence of postoperative anastomotic hemorrhage;The anus function after stoma closure;

Countries

China

Contacts

Public ContactTenghui Ma

Sixth Affiliated Hospital, Sun Yat-Sen University

austin_2004@163.com+86 13560232462

Outcome results

None listed

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