Laparoscopic Intersphincteric Resection in Elderly Patients

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04673526
• Other study ID #: Lap IRR 70+
• Status: Completed
• Phase: N/A
• Start date: January 1, 2009
• Est. completion date: December 31, 2016

Study information

• Verified date: December 2020
• Source: ASL Verbano Cusio Ossola
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Laparoscopic intersphincteric resection
Laparoscopic intersphincteric resection for ultra low rectal cancer in elderly patients
• Laparoscopic abdomino-perineal procedures
Abdominoperineal resection + colostomy in left iliac fossa or perineum

Locations

Country	Name	City	State
Italy	Sandro Zonta	Domodossola	VCO

Sponsors (2)

Lead Sponsor	Collaborator
ASL Verbano Cusio Ossola	Policlinico San Matteo Pavia Fondazione IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life of operated patients as assessed by Quality of Life Short Form Health Survey (QoL SF-36)	QoL SF-36 score (Quality of Life Short Form Health Survey from 0 to 100, with the lower score the more disability)	6 months after discharge
Primary	Quality of life associated to incontinence as assessed by Wexner incontinence score (WiS)	WiS (Wexner incontinence score) from 0 to 20: higher score means worse incontinence	6 months after discharge
Primary	Quality of life associated to incontinence as assessed by Faecal incontinence quality of life scale (FIQL)	FIQL (Faecal incontinence quality of life scale): 29 items from 1 to 6 - the lower value the worse quality of life	6 months after discharge
Secondary	Patients' survival	months	5 years
Secondary	Disease free survival	months	5 years
Secondary	Post-operative complications	Clavien-Dindo score from grade I (minor complications) to grade V (death)	6 months after discharge