PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS
Primary Purpose
Rectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Inferior mesenteric Vein dissection
Inferior mesenteric Artery dissection
Sponsored by
About this trial
This is an interventional prevention trial for Rectal Cancer focused on measuring Rectal cancer, Sexual dysfunction, Urinary dysfunction, Rectal nerves damage, Total Mesorectal Excision
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- women
- Under 18 years old;
- Not Candidate for neoadjuvant (chemoradiotherapy);
- Emergency surgery;
- Recurrent neoplasms
- cT4
- 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
Sites / Locations
- Parc Tauli University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Inferior mesenteric Vein dissection
Inferior mesenteric Artery dissection
Arm Description
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
As standard, the dissection starts straight in the inferior mesenteric artery and through the pelvis
Outcomes
Primary Outcome Measures
Changes in sexual dysfunction pre- and post-Total Mesorectal Excision
Sexual dysfunction pre- and post-Total Mesorectal Excision by sexual dysfunction scale IIEF-5
Secondary Outcome Measures
Full Information
NCT ID
NCT03520088
First Posted
April 3, 2018
Last Updated
June 21, 2018
Sponsor
Corporacion Parc Tauli
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
1. Study Identification
Unique Protocol Identification Number
NCT03520088
Brief Title
PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 3, 2018 (Anticipated)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporacion Parc Tauli
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Rectal cancer, Sexual dysfunction, Urinary dysfunction, Rectal nerves damage, Total Mesorectal Excision
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The analysis of the results will be blind for the investigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Inferior mesenteric Vein dissection
Arm Type
Experimental
Arm Description
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
Arm Title
Inferior mesenteric Artery dissection
Arm Type
Active Comparator
Arm Description
As standard, the dissection starts straight in the inferior mesenteric artery and through the pelvis
Intervention Type
Procedure
Intervention Name(s)
Inferior mesenteric Vein dissection
Intervention Description
Dissection of the Inferior mesenteric Vein first, and go down to the Artery during the total mesorectal excision
Intervention Type
Procedure
Intervention Name(s)
Inferior mesenteric Artery dissection
Intervention Description
Dissection of the Inferior mesenteric Artery directly in the total mesorectal excision
Primary Outcome Measure Information:
Title
Changes in sexual dysfunction pre- and post-Total Mesorectal Excision
Description
Sexual dysfunction pre- and post-Total Mesorectal Excision by sexual dysfunction scale IIEF-5
Time Frame
1 week before surgery and 12 months post-surgery
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male. The main objective of the study is asses the sexual dysfunction in male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
women
Under 18 years old;
Not Candidate for neoadjuvant (chemoradiotherapy);
Emergency surgery;
Recurrent neoplasms
cT4
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Pallisera-Lloveras, MD, PhD
Phone
34-93-723-1010
Ext
21490
Email
apallill@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Pallisera-Lloveras, MD, PhD
Organizational Affiliation
Corporacio Parc Tauli. Parc Tauli University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parc Tauli University Hospital
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Pallisera-Lloveras, MD,PhD
Phone
93-723-1010
Ext
21490
Email
apallill@gmail.com
First Name & Middle Initial & Last Name & Degree
Xavier Serra-Aracil, MD,PhD
Phone
93-723-1010
Ext
21490
Email
xserraa@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
31382934
Citation
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.
Results Reference
derived
Learn more about this trial
PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS
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