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Laparoscopic Intersphincteric Resection in Elderly Patients

NCT04673526 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2020-12-22

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Laparoscopic intersphincteric resection

Laparoscopic intersphincteric resection for ultra low rectal cancer in elderly patients

PROCEDURE

Laparoscopic abdomino-perineal procedures

Abdominoperineal resection + colostomy in left iliac fossa or perineum

Sponsors & Collaborators

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    collaborator OTHER

  • ASL Verbano Cusio Ossola

    lead OTHER_GOV

Principal Investigators

  • Sandro Zonta, PhD · ASL VCO

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-01
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04673526 on ClinicalTrials.gov