Urinary and Sexual Dysfunctions Evaluation After Rectal Resection

NCT ID: NCT04404673

Last Updated: 2020-05-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1172 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-21
• Study Completion Date: 2024-02-20

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.

Conditions

Rectal Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Open rectal resection

Evaluation of urinary and sexual dysfunction after rectal resection

Intervention Type: PROCEDURE

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

Laparoscopic rectal resection

Evaluation of urinary and sexual dysfunction after rectal resection

Intervention Type: PROCEDURE

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

Robotic rectal resection

Evaluation of urinary and sexual dysfunction after rectal resection

Intervention Type: PROCEDURE

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

Trans-anal TME (Ta-TME)

Evaluation of urinary and sexual dysfunction after rectal resection

Intervention Type: PROCEDURE

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

Interventions

Evaluation of urinary and sexual dysfunction after rectal resection

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondazione Policlinico Universitario Agostino Gemelli IRCCS di Roma

Rome, Lazio, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Sergio Alfieri, MD

Role: CONTACT

giuseppe.quero@policlinicogemelli.it

+393386792010

Facility Contacts

Sergio Alfieri, MD

Role: primary

giuseppe.quero@policlinicogemelli.it

+393386792010

Other Identifiers

2987

Identifier Type: -

Identifier Source: org_study_id