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| Name | Class |
|---|---|
| Paula Planelles-Soler | UNKNOWN |
| Laura Mora-Lopez | UNKNOWN |
| Naim Hannaoui | UNKNOWN |
| Sheila Serra-Pla |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Inferior mesenteric Artery dissection | Active Comparator | As standard, the dissection starts straight in the inferior mesenteric artery and through the pelvis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inferior mesenteric Vein dissection | Procedure | Dissection of the Inferior mesenteric Vein first, and go down to the Artery during the total mesorectal excision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in sexual dysfunction pre- and post-Total Mesorectal Excision | Sexual dysfunction pre- and post-Total Mesorectal Excision by sexual dysfunction scale IIEF-5 | 1 week before surgery and 12 months post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
Male. The main objective of the study is asses the sexual dysfunction in male
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Pallisera-Lloveras, MD, PhD | Contact | 34-93-723-1010 | 21490 | apallill@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Anna Pallisera-Lloveras, MD, PhD | Corporacio Parc Tauli. Parc Tauli University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parc Tauli University Hospital | Sabadell | Barcelona | 08208 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31382934 | Derived | 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. |
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| UNKNOWN |
| Arturo Dominguez-Garcia | UNKNOWN |
| Jesus Muñoz-Rodriguez | UNKNOWN |
| Joan Prats-Lopez | UNKNOWN |
| Salvador Navarro-Soto | UNKNOWN |
| Xavier Serra-Aracil | UNKNOWN |
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The analysis of the results will be blind for the investigator
| Inferior mesenteric Artery dissection | Procedure | Dissection of the Inferior mesenteric Artery directly in the total mesorectal excision |
|
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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