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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Laparoscopic intersphincteric resection for ultra low rectal cancer in elderly patients
Abdominoperineal resection + colostomy in left iliac fossa or perineum
Sandro Zonta
Domodossola, VCO, Italy
Quality of life of operated patients as assessed by Quality of Life Short Form Health Survey (QoL SF-36)
QoL SF-36 score (Quality of Life Short Form Health Survey from 0 to 100, with the lower score the more disability)
Time frame: 6 months after discharge
Quality of life associated to incontinence as assessed by Wexner incontinence score (WiS)
WiS (Wexner incontinence score) from 0 to 20: higher score means worse incontinence
Time frame: 6 months after discharge
Quality of life associated to incontinence as assessed by Faecal incontinence quality of life scale (FIQL)
FIQL (Faecal incontinence quality of life scale): 29 items from 1 to 6 - the lower value the worse quality of life
Time frame: 6 months after discharge
Patients' survival
months
Time frame: 5 years
Disease free survival
months
Time frame: 5 years
Post-operative complications
Clavien-Dindo score from grade I (minor complications) to grade V (death)
Time frame: 6 months after discharge
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