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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open rectal resection |
| ||
| Laparoscopic rectal resection |
| ||
| Robotic rectal resection |
| ||
| Trans-anal TME (Ta-TME) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of urinary and sexual dysfunction after rectal resection | Procedure | Comparison among the 4 different surgical approaches for urinary and sexual function |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | At 12 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with a diagnosis of rectal cancer referred to one of the centers involved in the study during the study period
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sergio Alfieri, MD | Contact | +393386792010 | giuseppe.quero@policlinicogemelli.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS di Roma | Recruiting | Rome | Lazio | 00168 | Italy |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| 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 |