Rectal CancerHiPNCT02702089
Hartmann's Versus Intersphincetric APE: A Prospective, Multicentre Study
An observational study of Rectal Cancer, run by Countess of Chester NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
14,000 new cases of rectal cancer are diagnosed each year, frail and elderly patients represent a rising proportion of these patients. Whilst the gold standard is often to remove the tumour and restore bowel continuity, surgeons will often avoid this procedure in this group of patients as they unfortunately tolerate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Rectal cancer surgery
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2016to Mar 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Frail patients with rectal cancer
Who may be able to join
- • Patients aged over 18 years
- Able to provide informed consent
- Undergoing elective, locally curative surgery for rectal cancer
- Recurrent rectal cancer not a contraindication if pre operative imaging suggests that the tumour can be removed with clear margins
- Primary anastomosis not appropriate for reasons of frailty, poor function or risks of anastomotic leak
- Local staging completed by MRI
- Histological confirmation of adenocarcinoma
- Fit for major resection
Who cannot join
- • Pregnant patients
- Patients unable to consent
- Local palliative resection (systemic metastatic disease not a contraindication)
- Suspicion of tumour perforation
- Rectal tumours requiring a formal APE due to distal tumour involvement of anorectal junction or pelvic floor
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Countess of Chester Hospital
Chester, Cheshire, CH2 1UL
About this study
14,000 new cases of rectal cancer are diagnosed each year, frail and elderly patients represent a rising proportion of these patients. Whilst the gold standard is often to remove the tumour and restore bowel continuity, surgeons will often avoid this procedure in this group of patients as they unfortunately tolerate surgical complications very poorly. Such surgical complications may present with life threatening sepsis, can prolong hospital stay, delay further cancer therapy and in the elderly or frail patient often leads to loss of independence and quality of life. In this setting, there are two alternative procedures (Hartmann's procedure OR intersphincteric APE) that may be used and these are employed in roughly equal measure in the UK (nationwide survey, Dec 2013, unpublished data). It is anecdotally felt that Hartmann's procedure (HP) has a greater risk of surgical complications (30%) and a few small retrospective studies have shown this (1-3), however there are no prospective data to support this view. Whilst some surgeons do choose intersphincteric APE (IAPE) on the basis of a lower surgical complication rate, many do not due to perceived limitations in the technique (longer operating time, risk of tumour perforation), which are unproven. We feel that a larger, prospective dataset is required to demonstrate the superiority of IAPE over HP and convince the remaining surgeons to change procedure. We have explored the possibility of a full randomised trial to answer this question, however this is not feasible due to the difficulty of randomisation of patients. Very little data are available regarding the use of IAPE in the setting of rectal cancer, however many surgeons who do employ the technique, specifically adapt their technique in this setting to reduce the chances of tumour perforation (two stage, stapling off rectum before removing anal canal separately). It is possible that those surgeons who prefer HP have not considered this, and combined with the lack of prospective data are reluctant to change technique. We are confident that if we can demonstrate a significant difference in surgical complication rate and promote a modification to the IAPE surgical technique then we can significantly reduce surgical harm to these frail patients.
Read the detailed description
Having established a network of units (UK and Europe) who are also keen to answer this question we have powered a prospective observational cohort study to demonstrate a significant reduction in surgical complication rate (30% to 15%). In conjunction with an on going Swedish randomised trial we hope that the data from this study will provide compelling evidence for UK surgeons to change practice. If the study reveals only a modest difference in complications, we will use the data gathered to design and reapply again for full funding for an RCT with the additional advantage of being able to clearly demonstrate a network of units capable of recruiting the necessary number of patients. The overarching aims of this study are therefore to:
- Determine the difference in surgical complication rates between HP and IAPE
- Assess the effect of IAPE technique on intra operative tumour perforation rate
The objectives of the study are to:
- Determine surgical complication rate for each procedure (graded by Clavien-Dindo)
- Assess impact on secondary outcomes (length of stay, readmission, reintervention, medical complications, time to chemotherapy, quality of life)
- Determine if the complication rate in IAPE is dependant on surgical technique
- Determine patient and clinician acceptability to randomisation if required
Data Collection
Data will be collected on specific CRF at baseline and 30 post operative days, all data will be completely anonymised and no further data will be collected past 30 days. The easy to use and well validated Clavien-Dindo scale will be use to grade surgical complications, but we will also calculate the Comprehensive Complication Index which integrates all medical and surgical complications and is felt to represent a more accurate estimation of post operative complications (4). Data will be collected at the following time points:
BASELINE INTRAOPERATIVE POST OPERATIVE (30 days) Age Surgical approach (lap, open) Pathological stage Sex Anaesthetic type TME quality BMI Operative time Length of stay Comorbidities Intra operative perforation Readmission ASA score Length of anorectal stump (HP) Surgical complications (Clavien-Dindo scale) Radiological stage Antibiotics Medical complications Distance of tumour from anal verge Method of IAPE (one vs two stage) Comprehensive Classification Index score Preoperative therapy 30 day quality of life Quality of life Patient willingness to randomise Reason for avoiding primary anastomosis Surgeon willingness to randomise Surgeon's reason for op choice
Data Analysis As this is an observation analysis, reporting only the unadjusted difference between HP and IAPE may result in a biased comparison. The primary analysis will therefore be a multivariable analysis adjusting for any confounding factors. To ensure the analysis is in keeping with the sample size calculation, evaluations of the primary outcome will be based on a 90% confidence interval.
- Conditions
- Rectal Cancer
- Being tested
- Rectal cancer surgery
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal cancer surgeryProcedure or surgery
Rectal cancer resection
| Study group | Role | What they receive |
|---|---|---|
| IAPE | Intersphincteric AP excision Receives: Procedure: Rectal cancer surgery | |
| HP | Hartmann's procedure Receives: Procedure: Rectal cancer surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
morbidity
Measured: 30 days
Secondary outcomes (5)
Quality of life
Measured: 90 days
Length of stay
Measured: 90 days
Readmission rate
Measured: 90 days
Time to chemotherapy
Measured: 90 days
Reintervention rate
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2019 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Countess of Chester NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dale Vimalachandran, Countess of Chester NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702089
- Sponsor's protocol ID
- Surg05/15
- Acronym
- HiP
- Status last verified
- Mar 2016
- First submitted
- 3 Mar 2016
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hartmann's Versus Intersphincetric APE: A Prospective, Multicentre Study
- ClinicalTrials.gov ID
- NCT02702089
- Acronym / sponsor ID
- HiP / Surg05/15
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Countess of Chester NHS Foundation TrustUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 8 Mar 2016 (estimated)
- 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.
14,000 new cases of rectal cancer are diagnosed each year, frail and elderly patients represent a rising proportion of these patients. Whilst the gold standard is often to remove the tumour and restore bowel continuity, surgeons will often avoid this procedure in this group of patients as they unfortunately tolerate surgical complications very poorly. Such surgical complications may present with life threatening sepsis, can prolong hospital stay, delay further cancer therapy and in the elderly or frail patient often leads to loss of independence and quality of life. In this setting, there are two alternative procedures (Hartmann's procedure OR intersphincteric APE) that may be used and these are employed in roughly equal measure in the UK (nationwide survey, Dec 2013, unpublished data). It is anecdotally felt that Hartmann's procedure (HP) has a greater risk of surgical complications (30%) and a few small retrospective studies have shown this (1-3), however there are no prospective data to support this view. Whilst some surgeons do choose intersphincteric APE (IAPE) on the basis of a lower surgical complication rate, many do not due to perceived limitations in the technique (longer operating time, risk of tumour perforation), which are unproven. We feel that a larger, prospective dataset is required to demonstrate the superiority of IAPE over HP and convince the remaining surgeons to change procedure. We have explored the possibility of a full randomised trial to answer this question, however this is not feasible due to the difficulty of randomisation of patients. Very little data are available regarding the use of IAPE in the setting of rectal cancer, however many surgeons who do employ the technique, specifically adapt their technique in this setting to reduce the chances of tumour perforation (two stage, stapling off rectum before removing anal canal separately). It is possible that those surgeons who prefer HP have not considered this, and combined with the lack of prospective data are reluctant to change technique. We are confident that if we can demonstrate a significant difference in surgical complication rate and promote a modification to the IAPE surgical technique then we can significantly reduce surgical harm to these frail patients.
Detailed description
Having established a network of units (UK and Europe) who are also keen to answer this question we have powered a prospective observational cohort study to demonstrate a significant reduction in surgical complication rate (30% to 15%). In conjunction with an on going Swedish randomised trial we hope that the data from this study will provide compelling evidence for UK surgeons to change practice. If the study reveals only a modest difference in complications, we will use the data gathered to design and reapply again for full funding for an RCT with the additional advantage of being able to clearly demonstrate a network of units capable of recruiting the necessary number of patients. The overarching aims of this study are therefore to:
- Determine the difference in surgical complication rates between HP and IAPE
- Assess the effect of IAPE technique on intra operative tumour perforation rate
The objectives of the study are to:
- Determine surgical complication rate for each procedure (graded by Clavien-Dindo)
- Assess impact on secondary outcomes (length of stay, readmission, reintervention, medical complications, time to chemotherapy, quality of life)
- Determine if the complication rate in IAPE is dependant on surgical technique
- Determine patient and clinician acceptability to randomisation if required
Data Collection
Data will be collected on specific CRF at baseline and 30 post operative days, all data will be completely anonymised and no further data will be collected past 30 days. The easy to use and well validated Clavien-Dindo scale will be use to grade surgical complications, but we will also calculate the Comprehensive Complication Index which integrates all medical and surgical complications and is felt to represent a more accurate estimation of post operative complications (4). Data will be collected at the following time points:
BASELINE INTRAOPERATIVE POST OPERATIVE (30 days) Age Surgical approach (lap, open) Pathological stage Sex Anaesthetic type TME quality BMI Operative time Length of stay Comorbidities Intra operative perforation Readmission ASA score Length of anorectal stump (HP) Surgical complications (Clavien-Dindo scale) Radiological stage Antibiotics Medical complications Distance of tumour from anal verge Method of IAPE (one vs two stage) Comprehensive Classification Index score Preoperative therapy 30 day quality of life Quality of life Patient willingness to randomise Reason for avoiding primary anastomosis Surgeon willingness to randomise Surgeon's reason for op choice
Data Analysis As this is an observation analysis, reporting only the unadjusted difference between HP and IAPE may result in a biased comparison. The primary analysis will therefore be a multivariable analysis adjusting for any confounding factors. To ensure the analysis is in keeping with the sample size calculation, evaluations of the primary outcome will be based on a 90% confidence interval.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IAPE | – | Procedure: Rectal cancer surgeryIntersphincteric AP excision |
| HP | – | Procedure: Rectal cancer surgeryHartmann's procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Frail patients with rectal cancer
Key inclusion criteria (8 listed)
- • Patients aged over 18 years
Key exclusion criteria (5 listed)
- • Pregnant patients
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 |
|---|---|---|
| Rectal cancer surgeryRectal cancer resection | Procedure or surgery | HP, IAPE |
Primary outcome
morbidity
Time frame: 30 days
5 secondary outcomes
Quality of life
Time frame: 90 days
Length of stay
Time frame: 90 days
Readmission rate
Time frame: 90 days
Time to chemotherapy
Time frame: 90 days
Reintervention rate
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Countess of Chester NHS Foundation Trust at 1 site in United Kingdom.
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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Mar 2016. 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 United Kingdom. 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?
Results are not available in the source record.
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?
morbidity (time frame: 30 days). 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 8 Mar 2016.