Laparoscopic Intersphincteric Resection in Elderly Patients

ASL Verbano Cusio Ossola

Status: Completed

Conditions: Rectal Cancer

Treatments: Procedure: Laparoscopic abdomino-perineal procedures; Procedure: Laparoscopic intersphincteric resection

Study type: Interventional

Funder types: Other

Identifiers

NCT04673526

Lap IRR 70+

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Intersphincteric resection

Experimental group

Description:

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.

Treatment:

Procedure: Laparoscopic intersphincteric resection

Abdomen-perineal procedures

Active Comparator group

Description:

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.

Treatment:

Procedure: Laparoscopic abdomino-perineal procedures