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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
40
Patients will receive Bergmann enema (30 ml) once daily from the start of radiotherapy until the 10th day after the end of radiotherapy.
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Incidence of grade 2 or higher radiation-induced rectal injury
Time frame: 3 months
Severity of radiation-induced rectal injury
Time frame: 3 months
Completion rate of short-course radiotherapy
Time frame: 9 months
Safety of Bergmann enema
Time frame: 9 months
Pathological complete response (pCR) rate
Time frame: 1 year
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