Clinical trial NCT04673526: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: intersphincteric resection
elderly
rectal cancer
Lead sponsor: ASL Verbano Cusio Ossola
Sponsor class: OTHER_GOV
Collaborators: name: Fondazione IRCCS Policlinico San Matteo di Pavia
First posted: 2020-12-17
Enrollment: 400
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective case-control study
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Patients over 70 years old who were affected by rectal cancer sited lower than 5 cm from anal verge and refused abdomen-perineal treatment.

Exclusion Criteria:

* Cancer extension over internal sphincteric muscle (T4) evaluated through MRI during staging work out;
* diabetic neuropathy conditioning previous partial/total incontinence;
* other pre-existing pathological condition affecting faecal incontinence.

Primary outcomes:
measure: Quality of life of operated patients as assessed by Quality of Life Short Form Health Survey (QoL SF-36)
timeFrame: 6 months after discharge
measure: Quality of life associated to incontinence as assessed by Wexner incontinence score (WiS)
timeFrame: 6 months after discharge
measure: Quality of life associated to incontinence as assessed by Faecal incontinence quality of life scale (FIQL)
timeFrame: 6 months after discharge
Secondary outcomes:
measure: Patients' survival
timeFrame: 5 years
measure: Disease free survival
timeFrame: 5 years
measure: Post-operative complications
timeFrame: 6 months after discharge
Other outcomes:
Locations:
city: Domodossola
country: Italy
facility: Sandro Zonta
state: VCO
Study officials:
affiliation: ASL VCO
name: Sandro Zonta, PhD
role: PRINCIPAL_INVESTIGATOR
References: