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Laparoscopic Intersphincteric Resection in Elderly Patients

NCT ID: NCT04673526

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-01

Study Completion Date

2016-12-31

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.

Detailed Description

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Conditions

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Rectal Cancer

Keywords

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intersphincteric resection elderly rectal cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Prospective case-control study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Laparoscopic intersphincteric resection

Intervention Type PROCEDURE

Laparoscopic intersphincteric resection for ultra low rectal cancer in elderly patients

Abdomen-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.

Group Type ACTIVE_COMPARATOR

Laparoscopic abdomino-perineal procedures

Intervention Type PROCEDURE

Abdominoperineal resection + colostomy in left iliac fossa or perineum

Interventions

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Laparoscopic intersphincteric resection

Laparoscopic intersphincteric resection for ultra low rectal cancer in elderly patients

Intervention Type PROCEDURE

Laparoscopic abdomino-perineal procedures

Abdominoperineal resection + colostomy in left iliac fossa or perineum

Intervention Type PROCEDURE

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.
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role collaborator

ASL Verbano Cusio Ossola

OTHER_GOV

Sponsor Role lead

Responsible Party

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Marco Giacometti

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sandro Zonta, PhD

Role: PRINCIPAL_INVESTIGATOR

ASL VCO

Locations

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Sandro Zonta

Domodossola, VCO, Italy

Site Status

Countries

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Italy

Other Identifiers

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Lap IRR 70+

Identifier Type: -

Identifier Source: org_study_id