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Prospective clinical study on the application of accelerated rehabilitation surgery management in patients with chronic radiation-induced small bowel injury and late complications

Prospective clinical study on the application of accelerated rehabilitation surgery management in patients with chronic radiation-induced small bowel injury and late complications

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035658
Enrollment
Unknown
Registered
2020-08-15
Start date
2020-08-17
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

Chronic Radiation Enteritis

Interventions

Experiment group :ERAS management

Sponsors

Sixth Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-70 years; 2. Patients with ECOG physical condition score of 0-2; 3. Preoperative albumin level >= 35g/L; 4. Patients with previous pathological diagnosis of pelvic tumors (Gynecology, prostate, urinary system); 5. Patients with a history of pelvic radiotherapy, at least 6 months from the end of the last radiotherapy; 6. Patients without recurrence or metastasis of primary tumor; 7. The late complications of CRE patients such as intestinal obstruction, intestinal fistula,etc.,who need resection of diseased bowel; 8. Patients who can tolerate general anesthesia; 9. 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 who need emergency operation; 2. Patients who didn't receiving resection of diseased bowel; 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 small intestinal resection; 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 moderate and severe complications after surgery;

Secondary

MeasureTime frame
The incidence of total complications 30 days after surgery;The incidence of individual complications 30 days after surgery;Length of stay;Length of stay after surgery;The in-patients costs;Score of patients' satisfaction ;EORTC QLQ;

Countries

China

Contacts

Public ContactTenghui Ma

The Sixth Affiliated Hospital of Sun Yat-Sen University

austin_2004@163.com+86 13560232462

Outcome results

None listed

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