Rectal CancerEURECANCT04404673
Urinary and Sexual Dysfunctions Evaluation After Rectal Resection
An observational study of Rectal Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Advances in the treatment of rectal cancer over the past two decades have improved survival and significantly reduced surgery-related morbidity. As a result, post-treatment quality of life (QoL) issues have become increasingly important. 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?
- Evaluation of urinary and sexual dysfunction after rectal resection
- Type of treatment
- Surgery or procedure
- How many people
- 1,172 participants
- Where
- 1 siteItaly
- Study dates
- 21 Feb 2020to 20 Feb 2024
- 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: All patients with a diagnosis of rectal cancer referred to one of the centers involved in the study during the study period
Who may be able to join
- All patients with a histopathological proven diagnosis of rectal carcinoma undergoing curative surgical resection
Who cannot join
- Patients aged < 18 years
- Inability to give informed consent
- Emergent surgeries
- Previous prostatic and/or colorectal surgery for benign or malignant diseases
- Preoperative sexual disorders (Female Sexual Function Index, FSFI ≤ 26.55 ; International Index Erectile Function , IIEF < 16)
- International Consultation on Incontinence Questionnaire > 5
- Clinically evident Benign Prostatic Hypertrophy (BPH) (International Prostatic Symptoms Score, IPSS > 20)
- Preoperative diagnosis of fecal and/or urinary incontinence.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS di Roma
Rome, Lazio, 00168
Sergio Alfieri, MD, +393386792010, giuseppe.quero@policlinicogemelli.it
About this study
Official title: Multicenter Prospective Evaluation of Urinary and Sexual Dysfunctions After Rectal Cancer Resection
Advances in the treatment of rectal cancer over the past two decades have improved survival and significantly reduced surgery-related morbidity. As a result, post-treatment quality of life (QoL) issues have become increasingly important. Urinary and sexual functions can be significantly altered after rectal resection, mainly due to the iatrogenic lesions of the pelvic autonomous lexus. Of note, their incidence is reported up to 70% and 30%, respectively. Despite the importance of this topic, most of the studies present in the literature are difficult to interpret for a variety of reasons. Firstly, both sexual and urinary dysfunctions lack a standardized definition. Secondly, the absence of baseline data, missing data, small sample sizes, and heterogeneity in the use of validated and nonvalidated instruments are the main limitation in drawing conclusive results. As additional factor, no clear evidence is present in the literature regarding the best approach to be used in order to preserve as much as possible both the sexual and urinary functionalities and to guarantee, at the same time, an adequate and oncologically correct rectal resection. Moreover, no data are currently present regarding the impact of pre-operative chemo-radiotherapy on the urinary and sexual functionalities. The main objective of the investigator's prospective study will be to define in a subjective manner which technique (open, laparoscopic, robot-assisted and Ta-TME) will guarantee the best urinary and sexual outcomes after rectal resection (with or without pre-operative chemo-radiotherapy) for the treatment of rectal carcinomas.
Thus, the primary endpoint will the post-operative evaluation at 1, 6 months and 1 year of the urinary and sexual functions by means of specific questionnaires.
Read more
Secondary endpoints will be:
- to investigate which technique (open, robotic, laparoscopic and trans-anal total mesorectal excision (TaTME)) more favorably correlate with urinary and sexual functions after radiochemotherapy (NAD+);
- the comparison of both the urinary and sexual dysfunction incidence on the base of the distance of the rectal tumor from the anal verge and the evaluation of the best approach to be used (open, laparoscopic, TaTME or robot-assisted) in relation to the tumor height;
- the short- (postoperative morbidity and histopathological data) and long-term (overall and disease-free survival) outcomes comparison among the open, laparoscopic, TaTME and robotic rectal resection.
- Conditions
- Rectal Cancer
- Being tested
- Evaluation of urinary and sexual dysfunction after rectal resection
- Keywords
- Urinary dysfunction, Sexual dysfunction, Rectal surgery, Minimally invasive surgery
- Medical subject headings
- Rectal Neoplasms, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of urinary and sexual dysfunction after rectal resectionProcedure or surgery
Comparison among the 4 different surgical approaches for urinary and sexual function
| Study group | Role | What they receive |
|---|---|---|
| Open rectal resection | Not described Receives: Procedure: Evaluation of urinary and sexual dysfunction after rectal resection | |
| Laparoscopic rectal resection | Not described Receives: Procedure: Evaluation of urinary and sexual dysfunction after rectal resection | |
| Robotic rectal resection | Not described Receives: Procedure: Evaluation of urinary and sexual dysfunction after rectal resection | |
| Trans-anal TME (Ta-TME) | Not described Receives: Procedure: Evaluation of urinary and sexual dysfunction after rectal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary and sexual outcomes after rectal resection
Which technique (open, laparoscopic, robot-assisted and Ta-TME) will guarantee the best urinary and sexual outcomes after rectal resection (with or without pre-operative chemo-radiotherapy) for the treatment of rectal carcinomas
Measured: At 1 month after surgery
Urinary and sexual outcomes after rectal resection
Which technique (open, laparoscopic, robot-assisted and Ta-TME) will guarantee the best urinary and sexual outcomes after rectal resection (with or without pre-operative chemo-radiotherapy) for the treatment of rectal carcinomas
Measured: At 6 months after surgery
Urinary and sexual outcomes after rectal resection
Which technique (open, laparoscopic, robot-assisted and Ta-TME) will guarantee the best urinary and sexual outcomes after rectal resection (with or without pre-operative chemo-radiotherapy) for the treatment of rectal carcinomas
Measured: At 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start21 Feb 2020
- Primary completion20 Feb 2024 (estimated)
- Study completion20 Feb 2024 (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.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,172 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404673
- Sponsor's protocol ID
- 2987
- Acronym
- EURECA
- Status last verified
- May 2020
- First submitted
- 19 May 2020
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Evaluation of Urinary and Sexual Dysfunctions After Rectal Cancer Resection
- ClinicalTrials.gov ID
- NCT04404673
- Acronym / sponsor ID
- EURECA / 2987
- Conditions
- Rectal Cancer
- Keywords
- Urinary dysfunction, Sexual dysfunction, Rectal surgery, Minimally invasive surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,172 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 20 Feb 2024 (estimated)
- Study completion
- 20 Feb 2024 (estimated)
- First posted
- 27 May 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.
Advances in the treatment of rectal cancer over the past two decades have improved survival and significantly reduced surgery-related morbidity. As a result, post-treatment quality of life (QoL) issues have become increasingly important. Urinary and sexual functions can be significantly altered after rectal resection, mainly due to the iatrogenic lesions of the pelvic autonomous lexus. Of note, their incidence is reported up to 70% and 30%, respectively. Despite the importance of this topic, most of the studies present in the literature are difficult to interpret for a variety of reasons. Firstly, both sexual and urinary dysfunctions lack a standardized definition. Secondly, the absence of baseline data, missing data, small sample sizes, and heterogeneity in the use of validated and nonvalidated instruments are the main limitation in drawing conclusive results. As additional factor, no clear evidence is present in the literature regarding the best approach to be used in order to preserve as much as possible both the sexual and urinary functionalities and to guarantee, at the same time, an adequate and oncologically correct rectal resection. Moreover, no data are currently present regarding the impact of pre-operative chemo-radiotherapy on the urinary and sexual functionalities. The main objective of the investigator's prospective study will be to define in a subjective manner which technique (open, laparoscopic, robot-assisted and Ta-TME) will guarantee the best urinary and sexual outcomes after rectal resection (with or without pre-operative chemo-radiotherapy) for the treatment of rectal carcinomas.
Thus, the primary endpoint will the post-operative evaluation at 1, 6 months and 1 year of the urinary and sexual functions by means of specific questionnaires.
Secondary endpoints will be:
- to investigate which technique (open, robotic, laparoscopic and trans-anal total mesorectal excision (TaTME)) more favorably correlate with urinary and sexual functions after radiochemotherapy (NAD+);
- the comparison of both the urinary and sexual dysfunction incidence on the base of the distance of the rectal tumor from the anal verge and the evaluation of the best approach to be used (open, laparoscopic, TaTME or robot-assisted) in relation to the tumor height;
- the short- (postoperative morbidity and histopathological data) and long-term (overall and disease-free survival) outcomes comparison among the open, laparoscopic, TaTME and robotic rectal resection.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Open rectal resection | – | Procedure: Evaluation of urinary and sexual dysfunction after rectal resection |
| Laparoscopic rectal resection | – | Procedure: Evaluation of urinary and sexual dysfunction after rectal resection |
| Robotic rectal resection | – | Procedure: Evaluation of urinary and sexual dysfunction after rectal resection |
| Trans-anal TME (Ta-TME) | – | Procedure: Evaluation of urinary and sexual dysfunction after rectal resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a diagnosis of rectal cancer referred to one of the centers involved in the study during the study period
Key inclusion criteria (1 listed)
- All patients with a histopathological proven diagnosis of rectal carcinoma undergoing curative surgical resection
Key exclusion criteria (8 listed)
- Patients aged < 18 years
- Inability to give informed consent
- Emergent surgeries
- Previous prostatic and/or colorectal surgery for benign or malignant diseases
- Preoperative sexual disorders (Female Sexual Function Index, FSFI ≤ 26.55 ; International Index Erectile Function , IIEF < 16)
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 |
|---|---|---|
| Evaluation of urinary and sexual dysfunction after rectal resectionComparison among the 4 different surgical approaches for urinary and sexual function | Procedure or surgery | Laparoscopic rectal resection, Open rectal resection, Robotic rectal resection, Trans-anal TME (Ta-TME) |
Primary outcome
Urinary and sexual outcomes after rectal resection
Time frame: At 1 month after surgery
Which technique (open, laparoscopic, robot-assisted and Ta-TME) will guarantee the best urinary and sexual outcomes after rectal resection (with or without pre-operative chemo-radiotherapy) for the treatment of rectal carcinomas
Urinary and sexual outcomes after rectal resection
Time frame: At 6 months after surgery
Which technique (open, laparoscopic, robot-assisted and Ta-TME) will guarantee the best urinary and sexual outcomes after rectal resection (with or without pre-operative chemo-radiotherapy) for the treatment of rectal carcinomas
Urinary and sexual outcomes after rectal resection
Time frame: At 12 months after surgery
Which technique (open, laparoscopic, robot-assisted and Ta-TME) will guarantee the best urinary and sexual outcomes after rectal resection (with or without pre-operative chemo-radiotherapy) for the treatment of rectal carcinomas
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
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 Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 8 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 27 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sergio Alfieri, MD (+393386792010, giuseppe.quero@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary and sexual outcomes after rectal resection (time frame: At 1 month after surgery). 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 27 May 2020.