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NCT Number: NCT04673526

Laparoscopic Intersphincteric Resection in Elderly Patients

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.

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Key information

Conditions

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

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sandro Zonta

Domodossola, VCO, 28845, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparoscopic intersphincteric resection

Procedure

Laparoscopic intersphincteric resection for ultra low rectal cancer in elderly patients

Laparoscopic abdomino-perineal procedures

Procedure

Abdominoperineal resection + colostomy in left iliac fossa or perineum

Primary outcomes

  1. Quality of life of operated patients as assessed by Quality of Life Short Form Health Survey (QoL SF-36)

    Time frame: 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)

  2. Quality of life associated to incontinence as assessed by Wexner incontinence score (WiS)

    Time frame: 6 months after discharge

    WiS (Wexner incontinence score) from 0 to 20: higher score means worse incontinence

  3. Quality of life associated to incontinence as assessed by Faecal incontinence quality of life scale (FIQL)

    Time frame: 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 outcomes

  1. Patients' survival

    Time frame: 5 years

    months

  2. Disease free survival

    Time frame: 5 years

    months

  3. Post-operative complications

    Time frame: 6 months after discharge

    Clavien-Dindo score from grade I (minor complications) to grade V (death)

Sponsors and collaborators

Lead sponsor

ASL Verbano Cusio Ossola

Other Gov

Collaborators

  • Fondazione IRCCS Policlinico San Matteo di Pavia

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Dec 17, 2020
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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