Laparoscopic Intersphincteric Resection in Elderly Patients

Study Overview
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Brief Summary
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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.

Official Title
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Laparoscopic Intersphincteric Resection for Ultra Low Rectal Cancer in Elderly Patients: Oncological and Functional Lon Term Outcome. A Prospective Case Control Study.

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: Laparoscopic intersphincteric resection
* Procedure: Laparoscopic abdomino-perineal procedures


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective case-control study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intersphincteric resection<br>After a laparoscopic TME (total mesorectal excision) is carried out down to the elevator ani plane and the anorectal junction, the intersphincteric plane is dissected, opening the space between puborectalis muscle and interior sphincter. Margin of resection is at least 1 cm below the lower margin of the tumor. Rectal excision is completed with transanal circumferential dissection and after specimen extraction through the anus, a colo-anal hand sewn anastomosis is fashioned. | Procedure: Laparoscopic intersphincteric resection<br>* Laparoscopic intersphincteric resection for ultra low rectal cancer in elderly patients<br>|
| Active Comparator: Abdomen-perineal procedures<br>After identification of the elevator ani plane, the descendent colon is transected with a linear stapler and a terminal stoma is fashioned. Then, a circumferential incision is made around anal orifice and perineal dissection is performed circumferentially to the pelvic cavity. Perineal defect is repaired performing mono-lateral or bilateral inferior gluteal flap. | Procedure: Laparoscopic abdomino-perineal procedures<br>* Abdominoperineal resection + colostomy in left iliac fossa or perineum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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 | 6 months after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' survival | months | 5 years | 
| Disease free survival | months | 5 years | 
| Post-operative complications | Clavien-Dindo score from grade I (minor complications) to grade V (death) | 6 months after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intersphincteric resection, elderly, rectal cancer