Research Objective and Principle: To evaluate the effectiveness of Bergmann enema in preventing acute radiation-induced rectal injury in patients with rectal cancer, thereby providing a basis for treatment options for potential radiation-induced rectal injury patients, aiming for adoption by international guidelines.
Primary Objective: Incidence of grade 2 or higher radiation-induced rectal injury.
Secondary Objectives: Severity of radiation-induced rectal injury, completion rate of short-course radiotherapy, safety of Bergmann enema, quality of life, pathological complete response (pCR) rate.
Study Design: Prospective, single-center, single-arm study.
Study Population and Expected Enrollment: Patients with rectal cancer undergoing short-course radiotherapy, expecting to enroll 40 patients.
Trial Duration: From December 2025 to December 2026.
Intervention: Patients will receive Bergmann enema (30 ml) once daily from the start of radiotherapy until the 10th day after the end of radiotherapy.
Statistical Hypothesis: Based on previous reports, the incidence of acute radiation-induced rectal injury is 80%, and it is expected that Bergmann enema preventive treatment can reduce it to 50%. The sample size was estimated using a formula designed to calculate single-group rate, with a set at 0.05 and a power of 80%. The study aimed to enroll at least 36 patients. Considering a dropout rate of 10%, at least 40 patients need to be included.
Aged 18 to 75 years, regardless of gender;
Fully understand this study and voluntarily sign the informed consent form, able to comply with the study protocol and complete all trial procedures;
Patients with pathologically confirmed mid-lower rectal cancer;
Undergoing short-course pelvic radiotherapy (total dose of 25-35Gy in 5.0-7.0 fractions over 5 consecutinve days);
Severe comorbidities, including uncontrolled stable medical diseases after treatment, or a history of neurological or psychiatric disorders (such as dementia or epilepsy), making them unsuitable for radiotherapy;
Patients who have received pelvic radiotherapy;
Presence of malignant pleural effusion or malignant abdominal effusion, or accompanied by bowel obstruction;
Pregnant or breastfeeding women;
Single group
Bergmann enema
DrugPatients will receive Bergmann enema (30 ml) once daily from the start of radiotherapy until the 10th day after the end of radiotherapy.
Incidence of grade 2 or higher radiation-induced rectal injury
Severity of radiation-induced rectal injury
Completion rate of short-course radiotherapy
Safety of Bergmann enema
Pathological complete response (pCR) rate
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
