Rectal CancerNCT03520088
PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS
A study testing Inferior mesenteric Vein dissection and Inferior mesenteric Artery dissection in people with Rectal Cancer, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
Purpose: The "Total Mesorectal Excision" (TME) is the standard surgical technique for the treatment of rectal cancer. Up to 50% of sexual dysfunction is described after TME and up to 30% of urinary dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Inferior mesenteric Vein dissection and Inferior mesenteric Artery dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 3 Sep 2018to 30 Dec 2022
- 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 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males;
- Age greater (or equal) to 18 years
- Diagnosed of rectal adenocarcinoma at ≤ 15 cm from the anal margin (by rigid rectoscopy)
- Candidate for neoadjuvant (chemoradiotherapy).
- Scheduled laparoscopic radical TME surgery carried out by colorectal surgeons;
- ASA I, II or III;
- Informed consent present.
Who cannot join
- women
- Under 18 years old;
- Not Candidate for neoadjuvant (chemoradiotherapy);
- Emergency surgery;
- Recurrent neoplasms
- cT4
Show all 10Show fewer
- Patient with a history of infra-abdominal, or pelvic surgery of the prostate, or radiotherapy prior to the current process;
- Patients with severe sexual dysfunction and neurological alterations before surgery
- Patients with neurogenic bladder before surgery.
- Not to sign the informed consent
Trial locations and contacts
1 site in 1 country.
Spain1 site
Parc Tauli University Hospital
Sabadell, Barcelona, 08208
Anna Pallisera-Lloveras, MD,PhD, 93-723-1010 ext. 21490, apallill@gmail.com
Xavier Serra-Aracil, MD,PhD, 93-723-1010 ext. 21490, xserraa@gmail.com
About this study
Purpose: The "Total Mesorectal Excision" (TME) is the standard surgical technique for the treatment of rectal cancer. Up to 50% of sexual dysfunction is described after TME and up to 30% of urinary dysfunction. The main objective of the study is to compare pre- and post-TME sexual dysfunction according to the approach of the inferior mesenteric vessels, directly on the IMA or from the inferior mesenteric vein (IMV) to the IMA.
Methods: Multicenter, prospective, controlled and randomized study of patients with rectal adenocarcinoma with neoadjuvant chemoradiotherapy, who will be randomized into two groups depending on the approach of the inferior mesenteric vessels. The main variable is pre and postoperative sexual dysfunction. The sample to be included will be 90 patients, 45 per group.
Read the detailed description
Purpose: The "Total Mesorectal Excision" (TME) is the standard surgical technique for the treatment of rectal cancer. Up to 50% of sexual dysfunction is described after TME and up to 30% of urinary dysfunction. Although there are other factors, the main cause of postoperative genitourinary dysfunction is intraoperative injury of the autonomic pelvic nerves. One of the regions with more risk is the Inferior Mesenteric Artery (IMA). The main objective of the study is to compare pre- and post-TME sexual dysfunction according to the approach of the inferior mesenteric vessels, directly on the IMA or from the inferior mesenteric vein (IMV) to the IMA.
Methods: Multicenter, prospective, controlled and randomized study of patients with rectal adenocarcinoma with neoadjuvant chemoradiotherapy, who will be randomized into two groups depending on the approach of the inferior mesenteric vessels. The main variable is pre and postoperative sexual dysfunction. The secondary variables are visualization and preservation of the pelvic autonomic nerves, pre- and postoperative urinary dysfunction, pre and postoperative quality of life. The sample to be included will be 90 patients, 45 per group.
- Conditions
- Rectal Cancer
- Being tested
- Inferior mesenteric Vein dissection, Inferior mesenteric Artery dissection
- Keywords
- Rectal cancer, Sexual dysfunction, Urinary dysfunction, Rectal nerves damage, Total Mesorectal Excision
- 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.
Inferior mesenteric Vein dissectionProcedure or surgery
Dissection of the Inferior mesenteric Vein first, and go down to the Artery during the total mesorectal excision
Inferior mesenteric Artery dissectionProcedure or surgery
Dissection of the Inferior mesenteric Artery directly in the total mesorectal excision
| Study group | Role | What they receive |
|---|---|---|
| Inferior mesenteric Vein dissection | Experimental | To improve and preserve the rectal nerve in the total mesorectal excision, its starts the dissection from the inferior mesenteric vein to the inferior mesenteric artery and through the pelvis Receives: Procedure: Inferior mesenteric Vein dissection |
| Inferior mesenteric Artery dissection | Active comparator | As standard, the dissection starts straight in the inferior mesenteric artery and through the pelvis Receives: Procedure: Inferior mesenteric Artery dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in sexual dysfunction pre- and post-Total Mesorectal Excision
Sexual dysfunction pre- and post-Total Mesorectal Excision by sexual dysfunction scale IIEF-5
Measured: 1 week before surgery and 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start3 Sep 2018 (estimated)
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Paula Planelles-Soler, Laura Mora-Lopez, Naim Hannaoui, Sheila Serra-Pla, Arturo Dominguez-Garcia, Jesus Muñoz-Rodriguez, Joan Prats-Lopez, Salvador Navarro-Soto, Xavier Serra-Aracil
- Responsible party
- Principal investigator, Anna Pallisera-Lloveras, Corporacion Parc Tauli
- Investigators
- Anna Pallisera-Lloveras, MD, PhD, Principal investigator, Corporacio Parc Tauli. Parc Tauli University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520088
- Sponsor's protocol ID
- TAU-RECTALNERV-PRESERV-2018
- Status last verified
- Jun 2018
- First submitted
- 3 Apr 2018
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pallisera-Lloveras A, Planelles-Soler P, Hannaoui N, Mora-Lopez L, Munoz-Rodriguez J, Serra-Pla S, Dominguez-Garcia A, Prats-Lopez J, Navarro-Soto S, Serra-Aracil X; Tauli-Colorectal Cancer Study Group. Dissection of the inferior mesenteric vein versus of the inferior mesenteric artery for the genitourinary function after laparoscopic approach of rectal cancer surgery: a randomized controlled trial. BMC Urol. 2019 Aug 5;19(1):75. doi: 10.1186/s12894-019-0501-5.
PubMed 31382934
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS
- ClinicalTrials.gov ID
- NCT03520088
- Acronym / sponsor ID
- TAU-RECTALNERV-PRESERV-2018
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, Sexual dysfunction, Urinary dysfunction, Rectal nerves damage, Total Mesorectal Excision
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Paula Planelles-Soler, Laura Mora-Lopez, Naim Hannaoui, Sheila Serra-Pla, Arturo Dominguez-Garcia, Jesus Muñoz-Rodriguez, Joan Prats-Lopez, Salvador Navarro-Soto, Xavier Serra-Aracil
- Study start
- 3 Sep 2018 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 9 May 2018 (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.
Purpose: The "Total Mesorectal Excision" (TME) is the standard surgical technique for the treatment of rectal cancer. Up to 50% of sexual dysfunction is described after TME and up to 30% of urinary dysfunction. The main objective of the study is to compare pre- and post-TME sexual dysfunction according to the approach of the inferior mesenteric vessels, directly on the IMA or from the inferior mesenteric vein (IMV) to the IMA.
Methods: Multicenter, prospective, controlled and randomized study of patients with rectal adenocarcinoma with neoadjuvant chemoradiotherapy, who will be randomized into two groups depending on the approach of the inferior mesenteric vessels. The main variable is pre and postoperative sexual dysfunction. The sample to be included will be 90 patients, 45 per group.
Detailed description
Purpose: The "Total Mesorectal Excision" (TME) is the standard surgical technique for the treatment of rectal cancer. Up to 50% of sexual dysfunction is described after TME and up to 30% of urinary dysfunction. Although there are other factors, the main cause of postoperative genitourinary dysfunction is intraoperative injury of the autonomic pelvic nerves. One of the regions with more risk is the Inferior Mesenteric Artery (IMA). The main objective of the study is to compare pre- and post-TME sexual dysfunction according to the approach of the inferior mesenteric vessels, directly on the IMA or from the inferior mesenteric vein (IMV) to the IMA.
Methods: Multicenter, prospective, controlled and randomized study of patients with rectal adenocarcinoma with neoadjuvant chemoradiotherapy, who will be randomized into two groups depending on the approach of the inferior mesenteric vessels. The main variable is pre and postoperative sexual dysfunction. The secondary variables are visualization and preservation of the pelvic autonomic nerves, pre- and postoperative urinary dysfunction, pre and postoperative quality of life. The sample to be included will be 90 patients, 45 per group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inferior mesenteric Vein dissection | Experimental | Procedure: Inferior mesenteric Vein dissectionTo improve and preserve the rectal nerve in the total mesorectal excision, its starts the dissection from the inferior mesenteric vein to the inferior mesenteric artery and through the pelvis |
| Inferior mesenteric Artery dissection | Active comparator | Procedure: Inferior mesenteric Artery dissectionAs standard, the dissection starts straight in the inferior mesenteric artery and through the pelvis |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males;
- Age greater (or equal) to 18 years
- Diagnosed of rectal adenocarcinoma at ≤ 15 cm from the anal margin (by rigid rectoscopy)
- Candidate for neoadjuvant (chemoradiotherapy).
- Scheduled laparoscopic radical TME surgery carried out by colorectal surgeons;
Key exclusion criteria (10 listed)
- women
- Under 18 years old;
- Not Candidate for neoadjuvant (chemoradiotherapy);
- Emergency surgery;
- Recurrent neoplasms
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 |
|---|---|---|
| Inferior mesenteric Vein dissectionDissection of the Inferior mesenteric Vein first, and go down to the Artery during the total mesorectal excision | Procedure or surgery | Inferior mesenteric Vein dissection |
| Inferior mesenteric Artery dissectionDissection of the Inferior mesenteric Artery directly in the total mesorectal excision | Procedure or surgery | Inferior mesenteric Artery dissection |
Primary outcome
Changes in sexual dysfunction pre- and post-Total Mesorectal Excision
Time frame: 1 week before surgery and 12 months post-surgery
Sexual dysfunction pre- and post-Total Mesorectal Excision by sexual dysfunction scale IIEF-5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- Derived from this study: PubMed 31382934Pallisera-Lloveras A, Planelles-Soler P, Hannaoui N, Mora-Lopez L, Munoz-Rodriguez J, Serra-Pla S, Dominguez-Garcia A, Prats-Lopez J, Navarro-Soto S, Serra-Aracil X; Tauli-Colorectal Cancer Study Group. Dissection of the inferior mesenteric vein versus of the inferior mesenteric artery for the genitourinary function after laparoscopic approach of rectal cancer surgery: a randomized controlled trial. BMC Urol. 2019 Aug 5;19(1):75. doi: 10.1186/s12894-019-0501-5.
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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.
Anna Pallisera-Lloveras, MD, PhD principal investigator
Corporacio Parc Tauli. Parc Tauli University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inferior mesenteric Vein dissection and Inferior mesenteric Artery dissection in people with Rectal Cancer, run by Corporacion Parc Tauli at 1 site in Spain.
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 7 inclusion and 10 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 25 Jun 2018. 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 Spain. 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 Anna Pallisera-Lloveras, MD, PhD (34-93-723-1010 ext. 21490, apallill@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in sexual dysfunction pre- and post-Total Mesorectal Excision (time frame: 1 week before surgery and 12 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03520088, which also lists 1 linked publication.
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 25 Jun 2018.