About this trial
The current internationally accepted treatment method for familial adenomatous polyposis is prophylactic total colorectal resection combined with endoscopic follow-up. However, total colorectal resection will bring a sharp decline in the quality of life of patients. Therefore, how to improve treatment methods and improve the quality of life for such patients under the premise of medical quality is the current medical focus. This study intends to establish three parallel observation cohorts, namely the surgical treatment group, the intensive colonoscopy treatment group, and the autonomous monitoring group. During the three-year study period, the investigators observed changes in the number of adenomas, carcinogenesis, and medical expenses in each group during the 3-year study period, and compared the groups to determine whether the intensive colonoscopy therapy has the possibility of delaying or replacing preventive surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The initial number of polyps is between 100-1000 visually;
Pathological diagnosis of multiple lesions confirmed colorectal adenoma;
Germline mutation detection is clearly a point mutation or large deletion of APC gene;
No cancer or distant metastasis.
Disqualifiers
Age <18, or >40 years old;
The initial number of polyps is <100, or >1000;
The polyp has become cancerous or has suspected distant metastasis;
Patients with intestinal obstruction, intestinal perforation, intestinal bleeding and other patients who need emergency surgical resection;
Trial population
The anticipants will be allocated in one of the three groups, and accept the corresponding intervention and at least 3 year follow up.
Trial design
Cohort
Prospective
Treatments tested in this trial
surgery
Procedure/SurgeryColorectal surgery, mainly total proctocolectomy.
enhanced colonoscopy
Procedure/SurgeryColonoscopic treatment and surveillance in every 3 months.
self choosed methods
Other interventionA patient chooses a method for himself other than surgery.
Treatment groups
Trial outcomes
Primary outcomes
3yCR
3 year Cancerous rate
Secondary outcomes
Adenoma number Change
Change of adenoma number by 3 years
3yOSR
3 year overall survival rate
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: