Clinical trial NCT04404673: Urinary and Sexual Dysfunctions Evaluation After Rectal Resection
Official title: Multicenter Prospective Evaluation of Urinary and Sexual Dysfunctions After Rectal Cancer Resection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rectal Cancer
Keywords: Urinary dysfunction
Sexual dysfunction
Rectal surgery
Minimally invasive surgery
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 1172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a diagnosis of rectal cancer referred to one of the centers involved in the study during the study period

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Urinary and sexual outcomes after rectal resection
timeFrame: At 1 month after surgery
measure: Urinary and sexual outcomes after rectal resection
timeFrame: At 6 months after surgery
measure: Urinary and sexual outcomes after rectal resection
timeFrame: At 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS di Roma
state: Lazio
Study officials:
References: