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Laparoscopic Intersphincteric Resection in Elderly Patients

Primary Purpose

Rectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Laparoscopic intersphincteric resection
Laparoscopic abdomino-perineal procedures
Sponsored by
ASL Verbano Cusio Ossola
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring intersphincteric resection, elderly, rectal cancer

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Sandro Zonta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intersphincteric resection

Abdomen-perineal procedures

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)
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
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

Secondary Outcome Measures

Patients' survival
months
Disease free survival
months
Post-operative complications
Clavien-Dindo score from grade I (minor complications) to grade V (death)

Full Information

First Posted
November 19, 2020
Last Updated
December 19, 2020
Sponsor
ASL Verbano Cusio Ossola
Collaborators
Fondazione IRCCS Policlinico San Matteo di Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT04673526
Brief Title
Laparoscopic Intersphincteric Resection in Elderly Patients
Official Title
Laparoscopic Intersphincteric Resection for Ultra Low Rectal Cancer in Elderly Patients: Oncological and Functional Lon Term Outcome. A Prospective Case Control Study.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2009 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ASL Verbano Cusio Ossola
Collaborators
Fondazione IRCCS Policlinico San Matteo di Pavia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
intersphincteric resection, elderly, rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective case-control study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intersphincteric resection
Arm Type
Experimental
Arm Description
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.
Arm Title
Abdomen-perineal procedures
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic intersphincteric resection
Intervention Description
Laparoscopic intersphincteric resection for ultra low rectal cancer in elderly patients
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic abdomino-perineal procedures
Intervention Description
Abdominoperineal resection + colostomy in left iliac fossa or perineum
Primary Outcome Measure Information:
Title
Quality of life of operated patients as assessed by Quality of Life Short Form Health Survey (QoL SF-36)
Description
QoL SF-36 score (Quality of Life Short Form Health Survey from 0 to 100, with the lower score the more disability)
Time Frame
6 months after discharge
Title
Quality of life associated to incontinence as assessed by Wexner incontinence score (WiS)
Description
WiS (Wexner incontinence score) from 0 to 20: higher score means worse incontinence
Time Frame
6 months after discharge
Title
Quality of life associated to incontinence as assessed by Faecal incontinence quality of life scale (FIQL)
Description
FIQL (Faecal incontinence quality of life scale): 29 items from 1 to 6 - the lower value the worse quality of life
Time Frame
6 months after discharge
Secondary Outcome Measure Information:
Title
Patients' survival
Description
months
Time Frame
5 years
Title
Disease free survival
Description
months
Time Frame
5 years
Title
Post-operative complications
Description
Clavien-Dindo score from grade I (minor complications) to grade V (death)
Time Frame
6 months after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandro Zonta, PhD
Organizational Affiliation
ASL VCO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sandro Zonta
City
Domodossola
State/Province
VCO
ZIP/Postal Code
28845
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Laparoscopic Intersphincteric Resection in Elderly Patients

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