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.

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.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: Laparoscopic intersphincteric resection; Procedure: Laparoscopic abdomino-perineal procedures

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • VCO
    • Domodossola, VCO, Italy, 28845
      • Sandro Zonta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Laparoscopic intersphincteric resection; Laparoscopic intersphincteric resection for ultra low rectal cancer in elderly patients
Active Comparator: 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.	Procedure: Laparoscopic abdomino-perineal procedures; Abdominoperineal resection + colostomy in left iliac fossa or perineum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' survival	months	5 years
Disease free survival	months	5 years
Post-operative complications	Clavien-Dindo score from grade I (minor complications) to grade V (death)	6 months after discharge

Collaborators and Investigators

• Sponsor: ASL Verbano Cusio Ossola
• Collaborators: Fondazione IRCCS Policlinico San Matteo di Pavia
• Investigators: Principal Investigator: Sandro Zonta, PhD, ASL VCO

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2009
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: December 12, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 19, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: elderly; rectal cancer; intersphincteric resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: Lap IRR 70+

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No