Laparoscopic Intersphincteric Resection in Elderly Patients

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04673526

Enrollment

400

Registered

2020-12-17

Start date

2009-01-01

Completion date

2016-12-31

Last updated

2020-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

intersphincteric resection, elderly, rectal cancer

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.

Interventions

PROCEDURELaparoscopic intersphincteric resection

Laparoscopic intersphincteric resection for ultra low rectal cancer in elderly patients

PROCEDURELaparoscopic abdomino-perineal procedures

Abdominoperineal resection + colostomy in left iliac fossa or perineum

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Prospective case-control study

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026