Laparoscopic Intersphincteric Resection in Elderly Patients
- Conditions
- Rectal Cancer
- Interventions
- Procedure: Laparoscopic abdomino-perineal proceduresProcedure: Laparoscopic intersphincteric resection
- Registration Number
- NCT04673526
- Lead Sponsor
- ASL Verbano Cusio Ossola
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- Patients over 70 years old who were affected by rectal cancer sited lower than 5 cm from anal verge and refused abdomen-perineal treatment.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Abdomen-perineal procedures Laparoscopic abdomino-perineal procedures 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. Intersphincteric resection Laparoscopic intersphincteric resection 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.
- Primary Outcome Measures
Name Time Method Quality of life of operated patients as assessed by Quality of Life Short Form Health Survey (QoL SF-36) 6 months after discharge QoL SF-36 score (Quality of Life Short Form Health Survey from 0 to 100, with the lower score the more disability)
Quality of life associated to incontinence as assessed by Wexner incontinence score (WiS) 6 months after discharge WiS (Wexner incontinence score) from 0 to 20: higher score means worse incontinence
Quality of life associated to incontinence as assessed by Faecal incontinence quality of life scale (FIQL) 6 months after discharge FIQL (Faecal incontinence quality of life scale): 29 items from 1 to 6 - the lower value the worse quality of life
- Secondary Outcome Measures
Name Time Method Patients' survival 5 years months
Disease free survival 5 years months
Post-operative complications 6 months after discharge Clavien-Dindo score from grade I (minor complications) to grade V (death)
Trial Locations
- Locations (1)
Sandro Zonta
🇮🇹Domodossola, VCO, Italy