Laparoscopic Intersphincteric Resection in Elderly Patients

NCT04673526 | Completed

• 1 other identifier: Lap IRR 70+
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

intersphincteric resection; elderly; rectal cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Patients' survival

  5 years

• Disease free survival

  5 years

• Post-operative complications

  6 months after discharge

Study Arms (2)

Intersphincteric resection

EXPERIMENTAL

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

Abdomen-perineal procedures

ACTIVE COMPARATOR

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

Interventions

Laparoscopic intersphincteric resection PROCEDURE

Laparoscopic intersphincteric resection for ultra low rectal cancer in elderly patients

Intersphincteric resection

Laparoscopic abdomino-perineal procedures PROCEDURE

Abdominoperineal resection + colostomy in left iliac fossa or perineum

Abdomen-perineal procedures

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients over 70 years old who were affected by rectal cancer sited lower than 5 cm from anal verge and refused abdomen-perineal treatment.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ASL Verbano Cusio Ossola: lead
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator

Study Sites (1)

Sandro Zonta

Domodossola, VCO, 28845, Italy

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Sandro Zonta, PhD

  ASL VCO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective case-control study

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 17, 2020
• Study Start: January 1, 2009
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)