Spots Global Cancer Trial Database for Laparoscopic Intersphincteric Resection in Elderly Patients
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Trial Identification
Brief Title: Laparoscopic Intersphincteric Resection in Elderly Patients
Official Title: Laparoscopic Intersphincteric Resection for Ultra Low Rectal Cancer in Elderly Patients: Oncological and Functional Lon Term Outcome. A Prospective Case Control Study.
Study ID: NCT04673526
Conditions
Study Description
Brief Summary: The aim of the present study is to assess if it is possible to offer intersphincteric rectal resection (IRR) to selected patients older than 70 years affected by ultra-low rectal cancer. The study, involving patients with rectal cancer at less than 5 cm from the anal verge, will compare elderly patients refusing standard sphincteric demolition and undergoing IRR, with some control groups (younger patients undergoing IRR, \>70 years old patients undergoing abdominoperineal resection + colostomy in left iliac fossa, \>70 years old patients undergoing abdominoperineal resection + perineal colostomy). The groups will be compared in terms of quality of life, quality of life associated to incontinence, overall survival, disease free survival and post-operative complications. This will be helpful to identify conditions for extending IRR to elderly patients. The study is run by Colo-rectal Surgery Unit at Policlinico San Matteo in Pavia (Italy) from 2009 to 2016, directly led by Dr. Sandro Zonta (principal investigator) and funded by the hospital itself.
Detailed Description:
Eligibility
Minimum Age: 70 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sandro Zonta, Domodossola, VCO, Italy
Contact Details
Name: Sandro Zonta, PhD
Affiliation: ASL VCO
Role: PRINCIPAL_INVESTIGATOR
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