Urinary and Sexual Dysfunctions Evaluation After Rectal Resection (EURECA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: Evaluation of urinary and sexual dysfunction after rectal resection

• Study Type: Observational
• Enrollment (Anticipated): 1172

Contacts and Locations

• Study Contact: Name: Sergio Alfieri, MD; Phone Number: +393386792010; Email: giuseppe.quero@policlinicogemelli.it

Study Locations

• Italy
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS di Roma
      • Contact: Sergio Alfieri, MD; Phone Number: +393386792010; Email: giuseppe.quero@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Open rectal resection	Procedure: Evaluation of urinary and sexual dysfunction after rectal resection; Comparison among the 4 different surgical approaches for urinary and sexual function
Laparoscopic rectal resection	Procedure: Evaluation of urinary and sexual dysfunction after rectal resection; Comparison among the 4 different surgical approaches for urinary and sexual function
Robotic rectal resection	Procedure: Evaluation of urinary and sexual dysfunction after rectal resection; Comparison among the 4 different surgical approaches for urinary and sexual function
Trans-anal TME (Ta-TME)	Procedure: Evaluation of urinary and sexual dysfunction after rectal resection; Comparison among the 4 different surgical approaches for urinary and sexual function

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 21, 2020
• Primary Completion (ANTICIPATED): February 20, 2024
• Study Completion (ANTICIPATED): February 20, 2024

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: May 25, 2020
• First Posted (ACTUAL): May 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 25, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Minimally invasive surgery; Rectal surgery; Sexual dysfunction; Urinary dysfunction
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: 2987

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No