Urinary and Sexual Dysfunctions Evaluation After Rectal Resection

NCT04404673 | Unknown DMC

• 1 other identifier: 2987
• Study Type: observational
• Target: 1,172
• Locations: 1 country
• Sites: 1

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

Keywords

Urinary dysfunction; Sexual dysfunction; Rectal surgery; Minimally invasive surgery

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

Open rectal resection

Procedure: Evaluation of urinary and sexual dysfunction after rectal resection

Laparoscopic rectal resection

Procedure: Evaluation of urinary and sexual dysfunction after rectal resection

Robotic rectal resection

Procedure: Evaluation of urinary and sexual dysfunction after rectal resection

Trans-anal TME (Ta-TME)

Procedure: Evaluation of urinary and sexual dysfunction after rectal resection

Interventions

Evaluation of urinary and sexual dysfunction after rectal resection PROCEDURE

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

Laparoscopic rectal resection; Open rectal resection; Robotic rectal resection; Trans-anal TME (Ta-TME)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS di Roma

Rome, Lazio, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Genital Diseases; Urogenital Diseases

Central Study Contacts

Sergio Alfieri, MD

CONTACT

+393386792010; giuseppe.quero@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 27, 2020
• Study Start: February 21, 2020
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: May 27, 2020

Record last verified: 2020-05

Locations

IT (1)