Rectal cancer.. Malignant neoplasm of rectum
Conditions
Interventions
Intervention group: T?N?M? rectal cancer patients? Patients are subjected to local transanal excision and after 2 to 4 weeks of operation or until recovery and repair of the operation area, patients a
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Age between 18 and 80 years. Histopathology; Well and moderately differentiated rectal adenocarcinoma was confirmed by biopsy. Close to the edge of the anus; The distance from the upper edge of the tumor to the anal verge is less than 6 cm, and its size is less than 5 cm, and the involvement is less than 30% of the rectal circumference. Absence of lymph node involvement based on pelvic MRI. Non-metastatic status is confirmed by Pan-CT scan. Patients who, due to the location of the tumor, need to perform abdominal-perineal resection of the tumor and remove the anus, or the patient's clinical condition does not allow major surgery.
Exclusion criteria
Exclusion criteria: Presence of biopsy with poorly differentiated rectal adenocarcinoma pathology. The distance from the anal verge is greater than or equal to 6 cm. The craniocaudal size of the tumor is greater than or equal to 5 cm. Involvement greater than or equal to 30% of the rectal circumference. Distant tumoral involvement; Confirmed by whole body CT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival. Timepoint: From the time of surgery to any local and systemic recurrence of the disease. Method of measurement: Follow-up based on examination and preclinical measures.;Loco-regional control. Timepoint: During surgery until local recurrence in the pelvis (tumor bed or mesorectal lymph nodes or inside the pelvis). Method of measurement: Follow up.;Tumor stage. Timepoint: Pelvic MRI at the beginning and then every 6 months to 2 years and annually to 5 years. Method of measurement: MRI.;Quality of Life. Timepoint: Before and after treatment. Method of measurement: EORTC QLQ-CR38 standard questionnaire.;CEA ( Carcinoembryonic antigen). Timepoint: Every three months to two years later, every 6 months to 5 years. Method of measurement: Lab exam. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMehdi Agili
Tehran University of Medical Sciences
Outcome results
None listed