Changhai Hospital
Shanghai, Shanghai Municipality, 200433, China
NCT Number: NCT04531930
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.
Trial opening soon.
Get Notified18 year–40 year
All sexes
Observational
Shanghai, Shanghai Municipality, 200433, China
Familial adenomatous polyposis is a kind of colorectal cancer syndrome, which belongs to rare diseases. It is estimated that the number of patients in China is about 100,000, accounting for about 1% of all colorectal cancer patients. This type of patients onset between the ages of ten and thirty years old. The typical manifestation is the growth of tens to thousands of colorectal adenomas, and the lifetime risk of colorectal cancer is close to 100%, accompanied by multiple extraintestinal manifestations . Without treatment, the average life span is 40-50 years. The current internationally accepted treatment method is prophylactic total colorectal resection combined with endoscopic follow-up. This program has a significant effect and can extend life expectancy by 10-20 years. However, total colorectal resection will bring a sharp decline in the quality of life of patients. The patients will lose many abilities (working ability, social ability, fertility, etc.) from the age of 20, and the prolonged survival period also brings more misery. This, in turn, also reduces the compliance of treatment. Many patients refuse to accept surgery and turn to endoscopic treatment or even give up treatment. However, there is currently no evidence that methods other than prophylactic surgery can effectively control the risk of colorectal cancer in such 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. Among them, the intensive colonoscopy treatment group will be treated with colonoscopy intensive treatment (that is, colonoscopy treatment is performed every 3 months, Carry out colorectal tumor reduction in segments, and continue to control the growth of adenomas several times) for patients who refuse surgery. 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, so as to explore ways to improve the quality of life of such patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Colorectal surgery, mainly total proctocolectomy.
Colonoscopic treatment and surveillance in every 3 months.
A patient chooses a method for himself other than surgery.
Time frame: 3 years
3 year Cancerous rate
Time frame: 3 years
Change of adenoma number by 3 years
Time frame: 3 years
3 year overall survival rate
Contact information is provided by the study sponsor or research team.
Changhai Hospital
Other
Cohort Study on Colorectal Adenoma Canceration in Familial Adenomatous Polyposis
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