Urinary and Sexual Dysfunctions Evaluation After Rectal Resection

• Conditions: Rectal Cancer
• Interventions: Procedure: Evaluation of urinary and sexual dysfunction after rectal resection

• Registration Number: NCT04404673
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-21
• Status Verified: 2020-05
• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-25
• Last Update Submitted: 2020-05-25
• Study First Posted: 2020-05-27
• Last Update Posted: 2020-05-27
• Primary Completion: 2024-02-20
• Study Completion: 2024-02-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1172

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Laparoscopic rectal resection	Evaluation of urinary and sexual dysfunction after rectal resection	-
Open rectal resection	Evaluation of urinary and sexual dysfunction after rectal resection	-
Trans-anal TME (Ta-TME)	Evaluation of urinary and sexual dysfunction after rectal resection	-
Robotic rectal resection	Evaluation of urinary and sexual dysfunction after rectal resection	-

Primary Outcome Measures

Name	Time	Method
Urinary and sexual outcomes after rectal resection	At 12 months after surgery	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

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS di Roma; 🇮🇹 Roma, Lazio, Italy