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Urinary and Sexual Dysfunctions Evaluation After Rectal Resection

Multicenter Prospective Evaluation of Urinary and Sexual Dysfunctions After Rectal Cancer Resection

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04404673
Acronym
EURECA
Enrollment
1172
Registered
2020-05-27
Start date
2020-02-21
Completion date
2024-02-20
Last updated
2020-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

Urinary dysfunction, Sexual dysfunction, Rectal surgery, Minimally invasive surgery

Brief 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. 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.

Interventions

PROCEDUREEvaluation of urinary and sexual dysfunction after rectal resection

Comparison among the 4 different surgical approaches for urinary and sexual function

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients with a histopathological proven diagnosis of rectal carcinoma undergoing curative surgical resection

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Urinary and sexual outcomes after rectal resectionAt 1 month after surgeryWhich 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

Countries

Italy

Contacts

Primary ContactSergio Alfieri, MD
giuseppe.quero@policlinicogemelli.it+393386792010

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026