Rectal CancerNCT04673526
Laparoscopic Intersphincteric Resection in Elderly Patients
A study testing Laparoscopic intersphincteric resection and Laparoscopic abdomino-perineal procedures in people with Rectal Cancer, run by ASL Verbano Cusio Ossola at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Laparoscopic intersphincteric resection and Laparoscopic abdomino-perineal procedures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2009to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients over 70 years old who were affected by rectal cancer sited lower than 5 cm from anal verge and refused abdomen-perineal treatment.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Rectal Cancer
- Being tested
- Laparoscopic intersphincteric resection, Laparoscopic abdomino-perineal procedures
- Keywords
- intersphincteric resection, elderly, rectal cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic intersphincteric resectionProcedure or surgery
Laparoscopic intersphincteric resection for ultra low rectal cancer in elderly patients
Laparoscopic abdomino-perineal proceduresProcedure or surgery
Abdominoperineal resection + colostomy in left iliac fossa or perineum
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Laparoscopic abdomino-perineal procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 6 months after discharge
Secondary outcomes (3)
Patients' survival
months
Measured: 5 years
Disease free survival
months
Measured: 5 years
Post-operative complications
Clavien-Dindo score from grade I (minor complications) to grade V (death)
Measured: 6 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Jan 2009
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective case-control study
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASL Verbano Cusio Ossola
- Sponsor type
- Other government
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Responsible party
- Principal investigator, Marco Giacometti, ASL Verbano Cusio Ossola
- Investigators
- Sandro Zonta, PhD, Principal investigator, ASL VCO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673526
- Sponsor's protocol ID
- Lap IRR 70+
- Status last verified
- Dec 2020
- First submitted
- 19 Nov 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Intersphincteric Resection for Ultra Low Rectal Cancer in Elderly Patients: Oncological and Functional Lon Term Outcome. A Prospective Case Control Study.
- ClinicalTrials.gov ID
- NCT04673526
- Acronym / sponsor ID
- Lap IRR 70+
- Conditions
- Rectal Cancer
- Keywords
- intersphincteric resection, elderly, rectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- ASL Verbano Cusio OssolaOther government
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective case-control study
| Arm | Type | Receives |
|---|---|---|
| Intersphincteric resection | Experimental | Procedure: Laparoscopic intersphincteric resectionAfter 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. |
| Abdomen-perineal procedures | Active comparator | Procedure: Laparoscopic abdomino-perineal proceduresAfter 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients over 70 years old who were affected by rectal cancer sited lower than 5 cm from anal verge and refused abdomen-perineal treatment.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic intersphincteric resectionLaparoscopic intersphincteric resection for ultra low rectal cancer in elderly patients | Procedure or surgery | Intersphincteric resection |
| Laparoscopic abdomino-perineal proceduresAbdominoperineal resection + colostomy in left iliac fossa or perineum | Procedure or surgery | Abdomen-perineal procedures |
Primary outcome
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)
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
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
3 secondary outcomes
Patients' survival
Time frame: 5 years
Disease free survival
Time frame: 5 years
Post-operative complications
Time frame: 6 months after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandro Zonta, PhD principal investigator
ASL VCO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic intersphincteric resection and Laparoscopic abdomino-perineal procedures in people with Rectal Cancer, run by ASL Verbano Cusio Ossola at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.