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Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

To improve and preserve the rectal nerve in the total mesorectal excision, its starts the dissection from the inferior mesenteric vein to the inferior mesenteric artery and through the pelvis

As standard, the dissection starts straight in the inferior mesenteric artery and through the pelvis

Dissection of the Inferior mesenteric Vein first, and go down to the Artery during the total mesorectal excision

Inferior mesenteric Vein dissection

Dissection of the Inferior mesenteric Artery directly in the total mesorectal excision

Inferior mesenteric Artery dissection

Anna Pallisera-Lloveras, MD, PhD

Anna Pallisera-Lloveras, MD,PhD

Xavier Serra-Aracil, MD,PhD

Purpose: The "Total Mesorectal Excision" (TME) is the standard surgical technique for the treatment of rectal cancer. Up to 50% of sexual dysfunction is described after TME and up to 30% of urinary dysfunction. The main objective of the study is to compare pre- and post-TME sexual dysfunction according to the approach of the inferior mesenteric vessels, directly on the IMA or from the inferior mesenteric vein (IMV) to the IMA.

Methods: Multicenter, prospective, controlled and randomized study of patients with rectal adenocarcinoma with neoadjuvant chemoradiotherapy, who will be randomized into two groups depending on the approach of the inferior mesenteric vessels. The main variable is pre and postoperative sexual dysfunction. The sample to be included will be 90 patients, 45 per group.

Purpose: The "Total Mesorectal Excision" (TME) is the standard surgical technique for the treatment of rectal cancer. Up to 50% of sexual dysfunction is described after TME and up to 30% of urinary dysfunction. Although there are other factors, the main cause of postoperative genitourinary dysfunction is intraoperative injury of the autonomic pelvic nerves. One of the regions with more risk is the Inferior Mesenteric Artery (IMA). The main objective of the study is to compare pre- and post-TME sexual dysfunction according to the approach of the inferior mesenteric vessels, directly on the IMA or from the inferior mesenteric vein (IMV) to the IMA.

Methods: Multicenter, prospective, controlled and randomized study of patients with rectal adenocarcinoma with neoadjuvant chemoradiotherapy, who will be randomized into two groups depending on the approach of the inferior mesenteric vessels. The main variable is pre and postoperative sexual dysfunction. The secondary variables are visualization and preservation of the pelvic autonomic nerves, pre- and postoperative urinary dysfunction, pre and postoperative quality of life. The sample to be included will be 90 patients, 45 per group.

The analysis of the results will be blind for the investigator

Male. The main objective of the study is asses the sexual dysfunction in male

PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS

Sexual dysfunction pre- and post-Total Mesorectal Excision by sexual dysfunction scale IIEF-5

Paula Planelles-Soler

Laura Mora-Lopez

Naim Hannaoui

Sheila Serra-Pla

Arturo Dominguez-Garcia

Jesus Muñoz-Rodriguez

Joan Prats-Lopez

Salvador Navarro-Soto

Xavier Serra-Aracil

Corporacion Parc Tauli

md, PhD

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

Evaluation of urinary and sexual dysfunction after rectal resection

Sergio Alfieri, MD

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.

Urinary and Sexual Dysfunctions Evaluation After Rectal Resection

Multicenter Prospective Evaluation of Urinary and Sexual Dysfunctions After Rectal Cancer 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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Ureteral Obstruction

Ureteral Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Group A: Participants in this group will receive a standard of care ureteral stenting performed by a urologist.

Participants in this group will receive a standard of care percutaneous nephrostomy tube placement performed by an interventional radiologist.

A ureteral stent is a soft, hollow tube that is placed temporarily into the ureter. The stent allows the urine to drain. The stent has a coil on each end that keeps it from moving. The top end coils in the kidney and the lower end coils inside the bladder.

Ureteral Stent

A percutaneous nephrostomy is the placement of a small, flexible rubber tube (catheter) through your skin into your kidney to drain your urine. It is inserted through your back or flank.

Percutaneous Nephrostomy Tube Placement

Clinical Trials

Cancer Clinical Trials Office

Parth Modi, MD

This research study will compare two procedures commonly used to treat urinary obstruction due to cancer. Sometimes cancer blocks one or both ureters (narrow tubes in the body that carry urine from the kidneys to the bladder). When these ureters become blocked, the body can no longer properly drain urine. This blocking of the ureters is called urinary obstruction, which can lead to kidney problems, infection, and pain. Treatment options for urinary obstruction include ureteral stent placement and percutaneous nephrostomy tube placement. Both treatment options require a doctor to place soft tubes (like a catheter) inside the body to help the ureters properly drain urine. These two treatment options have different success rates, risks, and effects on quality of life. By doing this study, researchers hope to learn which treatment option is best for individuals who develop urinary obstruction because of cancer. Participation in this research will last about 3 months.

This research study will compare two procedures commonly used to treat urinary obstruction due to cancer. Sometimes cancer blocks one or both ureters (narrow tubes in the body that carry urine from the kidneys to the bladder). When these ureters become blocked, the body can no longer properly drain urine. This blocking of the ureters is called urinary obstruction, which can lead to kidney problems, infection, and pain.

Treatment options for urinary obstruction include ureteral stent placement and percutaneous nephrostomy tube placement. Both treatment options require a doctor to place soft tubes inside the body to help the ureters properly drain urine. A ureteral stent is an internal drainage tube allowing urine to drain from your kidney down to your bladder. The percutaneous nephrostomy tube is a tube that comes out your back that drains urine into a bag. These two treatment options have different success rates, risks, and effects on quality of life. By doing this study, researchers hope to learn which treatment option is best for individuals who develop urinary obstruction due to cancer. Participation in this research will last about 3 months.

If you agree to participate:

* The study doctor will not pick which one of the two treatments described above you will receive. We will use a computer to place you in one of the two study groups. The group the computer picks is by chance, like a flip of a coin. This is also called "randomization." You will have an equal chance of being in either group.
* You will receive either a retrograde ureteral stent or a percutaneous nephrostomy tube. A member of the research team will tell you which of the two treatments you will get, after the selection has been made.

Obstruction of Malignancy: Percutaneous Renal vs Endoscopic Stent

DECOMPRESS (DECompressing Obstruction of Malignancy: Percutaneous Renal vs Endoscopic Stent)

The feasibility of a definitive randomized trial, specifically to quantify patient willingness to be randomly assigned treatment with retrograde ureteral stent versus percutaneous nephrostomy tube placement for malignant ureteral obstruction. The number of patient eligible and subsequent recruitment rates. Feasibility will be defined as successfully enrolling 50 patients in the 12 month enrollment period.

The rate of technical success when randomizing patients to percutaneous nephrostomy or ureteral stent placement for managing malignant ureteral obstruction. This rate of technical success will be assessed by:

* Decompression failure (defined as any of the following: technical failure of study procedure, stable or worsening hydronephrosis on imaging at 3 months follow up, urosepsis within 3 months of procedure, or need for additional decompression procedure (stent or nephrostomy placement) within 2 months after initial procedure
* Adverse surgical events (defined as grade ≥3 Clavien-Dindo classification)
* Patient reported outcomes at baseline, 7-day, 30-day and 90-day post-procedure using the Brief Pain Inventory, PROMIS Adult Physical Function Short Form (v2.0), and American Urological Association Symptom Score
* Compliance rate with questionnaires
* Reasons for non-randomisation, percentage of non-consenting participants who choose nephrostomy vs. retrograde ureteral stenting

University of Chicago

Behaviors and Mental Disorders

Quality of Life

Advances in rectal cancer management have significantly reduced morbidity and mortality. The most commonly performed operation for rectal cancer is restorative proctectomy (RP), leaving up to 70% with long-term bowel dysfunction called Low Anterior Resection Syndrome (LARS). LARS manifests as stool frequency, incontinence and difficult defecation. LARS, along with other functional impairments such as sexual and urinary dysfunction (SUD), can impact quality of life (QoL) and cause emotional distress. High-quality longitudinal data on these sequalae are lacking, leading to variable estimates of their prevalence, risk factors and prognosis. Most studies are European, cross-sectional, lack pre-treatment evaluation and long-term follow-up, and use inconsistent assessment measures. Thus, a North American study that evaluates patients longitudinally from diagnosis will provide quality data to fill this knowledge gap.

The main aim of the proposed study is to contribute evidence regarding the impact of LARS, SUD, emotional/financial distress, and patient activation on long-term post-treatment QoL in North American rectal cancer after RP.

This multicenter North American, observational, prospective cohort study relies on validated patient reported outcome measures (PROMs) at diagnosis, during and post-treatment. Patients from 20 sites will be recruited over 2 years and followed for 3 years. The primary endpoint is QoL as measured by the European Organization for Research \& Treatment of Cancer QoL questionnaire. We anticipate accrual of 1200 patients. Factors associated with QoL will be explored. Impact of patient activation in relation to functional outcomes on QoL over time will be explored using a difference-in-differences approach. The study involves a multidisciplinary team who will provide expertise in research methodology, nursing, oncology and surgery.

The main contributions of this study are 1) provision of reference baseline North American values for important rectal cancer PROMs for clinical and research use, 2) an understanding of the evolution of functional outcomes and QoL post-treatment to counsel patients peri-operatively and throughout survivorship, and 3) to provide the basis for future tailored programs to support rectal cancer survivors.

Advances in rectal cancer management have significantly reduced morbidity and mortality. The most commonly performed operation for rectal cancer is restorative proctectomy (RP), leaving up to 70% with long-term bowel dysfunction called Low Anterior Resection Syndrome (LARS). LARS manifests as stool frequency, incontinence and difficult defecation. LARS, along with other functional impairments such as sexual and urinary dysfunction (SUD), can impact quality of life (QoL) and cause emotional distress. There is no well-established treatment strategy for LARS or SUD. High-quality longitudinal data on these sequalae are lacking, leading to variable estimates of their prevalence, risk factors and prognosis. Most studies are European, cross-sectional, lack pre-treatment evaluation and long-term follow-up, and use inconsistent assessment measures. Thus, a North American study that evaluates patients longitudinally from diagnosis will provide quality data to fill this knowledge gap.

The main aim of the proposed study is to contribute evidence regarding the impact of LARS, SUD, emotional/financial distress, and patient activation on long-term post-treatment QoL in North American rectal cancer after RP. This study aims to address the following research questions: 1): How do North American rectal cancer patients who underwent RP experience changes in function (bowel, sexual and urinary), distress (emotional and financial) and QoL after RP from baseline through early and late timepoints following treatment? 2): How do patient-, disease-, treatment-, functional- and distress-related factors predict QoL at baseline and at early and late timepoints post-treatment?

This multicenter North American, observational, prospective cohort study relies on validated patient reported outcome measures (PROMs) at diagnosis, during and post-treatment. Patients from 20 sites will be recruited over 2 years and followed for 3 years. The primary endpoint is QoL as measured by the European Organization for Research \& Treatment of Cancer QoL questionnaire. We anticipate accrual of 1200 patients. Estimating a 30% attrition rate, in 1000 different simulated datasets and α=0.05, we will be able to detect a 1 point difference in QoL 88% of the time (95%CI: 85.8, 90.0). Given that a 10-point difference is considered clinically significant, this sample size affords good precision. 1) QoL, LARS, SUD, emotional/financial distress will be measured at baseline, early (12 \& 18 months) and late (2 \& 3 years) timepoints. 2) Changes over time for each outcome will be studied using linear mixed models (LMM) and generalized LMM as appropriate to account for the hierarchical and longitudinal structure of the data. 3) Factors associated with QoL will be explored using LMM. 4) Impact of patient activation in relation to functional outcomes on QoL over time will be explored using a difference-in-differences approach. The study involves a multidisciplinary team who will provide expertise in research methodology, nursing, oncology and surgery.

The main contributions of this study are 1) provision of reference baseline North American values for important rectal cancer PROMs for clinical and research use, 2) an understanding of the evolution of functional outcomes and QoL post-treatment to counsel patients peri-operatively and throughout survivorship, and 3) to provide the basis for future tailored programs to support rectal cancer survivors.

The OPERa Study: Evaluating QoL After Rectal Cancer Surgery

The OPERa Study: A Multicenter Observational Prospective Cohort Study to Evaluate Determinants of Long-Term Quality of Life Following Restorative Proctectomy for Rectal Cancer Treatment

Global QoL as measured by the European Organization for Research \& Treatment of Cancer QoL questionnaire (EORTC QLQ-C30). Linear transformation is used to standardize raw score, so that scores range from 0 to 100; higher score represents better functioning or worse level of symptoms.

Measured by the Low Anterior Resection Syndrome Score (LARS Score). Score ranges from 0 to 42 points. 0-20: no LARS; 21-29 minor LARS; 30-42 major LARS.

Measured for females by the Female Sexual Function Index (FSFI). FSFI: Minimum score 0, maximum score 36; higher score means better sexual function.

Measured for males by the International Index of Erectile Function (IIEF). IIEF: Minimum score 0, maximum score 30. Higher score means better sexual function; higher score means better sexual function.

Measured for females by the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS). ICIQ-FLUTS: Minimum score 0, maximum score 48; Higher score means worse urinary symptoms.

Measured for males by the International Prostate Symptom Score (IPSS). IPSS: Minimum score 0, maximum score 35. Higher sore means worse urinary symptoms.

Measured by the Hospital Anxiety and Depression Scale (HADS). HADS: Minimum score 0, maximum score 21; Higher score means greater emotional distress.

Measured by a 7-level Likert scale questionnaire will be used to assess patients' perceived financial distress in relation to their disease. Minimum score 2, maximum score 14; Higher score means greater financial strain.

Measured by the Patient Activation Measure (PAM-13). PAM-13: Minimum score 0, maximum score 100; increased score means greater patient activation.

Measured by the Targeted Geriatric Assessment (TaGA). TaGA: Minimum score 0, maximum score 1; Higher score means increased frailty.

Jewish General Hospital

Associate Professor

Participants will undergo laparoscopic FTME surgery.

Nerve plane was defined as the overlying tiny membranous tissue including the nerves, the adipose tissue and the extremely tiny capillaries around the nerve. Following the TME principles, the surgical procedure of FTME was guided by the nerve plane and dissected between the proper fascia of the rectum and nerve plane (the first gap), which could ensure completeness of the nerve plane and the proper fascia of the rectum.

Laparoscopic FTME surgery

Yongbin Zheng, M.D,Ph.D

Urinary and sexual dysfunctions are among the most common complications in rectal cancer surgery. The aim of this study was to investigate the protective effect of laparoscopic functional total mesorectum excision (FTME) on urinary and sexual function in male patients with mid-low rectal cancer. This is a prospective, single-arm, multicenter, uncontrolled, clinical study in 88 eligible subjects with mid-low rectal cancer. After informed consent, eligible patients will be performed laparoscopic FTME surgery. Patients' demographic, operative detail, postoperative outcomes and follow-up will be recorded prospectively.

Previously, our studies have demonstrated the presence of nerve plane in laparoscopic rectal cancer surgery, which was the overlying tiny membranous tissue including the nerves, the adipose tissue, and the extremely tiny capillaries around the nerve. As a consequence, the concept of nerve plane-oriented functional total mesorectal excision (FTME) was proposed as an optimal surgical procedure about pelvic autonomic nerve preservation in rectal cancer surgery. Following the TME principles, the surgical procedure of FTME was guided by the nerve plane and dissected between the proper fascia of the rectum and nerve plane (the first gap), which could ensure completeness of the nerve plane and the proper fascia of the rectum. This surgical procedure not only ensures radical resection but also protects PAN better, and the investigators also showed the difference between routine TME and FTME in our previous study, which included inferior mesenteric plexus preservation, station 253 nodes dissection, existence of the first gap, Waldeyer's fascia and Denonvillier's fascia (DVF) preservation, neurovascular bundles preservation, and completeness of mesorectum and nerve plane. Currently, it was a lack of higher-level evidence-based evidence to confirm the protective effect of laparoscopic FTME on urinary and sexual function in male patients with mid-low rectal cancer. In the present study, the investigators performed the prospective, single-arm, multicenter, uncontrolled clinical study, eligible patients will be performed laparoscopic FTME surgery. Postoperative sexual function, urinary function, complications, quality of life, recurrence rate, recurrence patterns, disease-free survival, and overall survival will be recorded prospectively. The results of the patients will be assessed to validate postoperative functional outcomes and oncologic outcomes of laparoscopic FTME surgery.

Multicenter Study on Postoperative Urinary and Sexual Function During Laparoscopic Functional Total Mesorectum Excision

A Prospective, Multicenter Clinical Study of Preservative Effect on Postoperative Urinary and Sexual Function During Laparoscopic Functional Total Mesorectum Excision for Male Rectal Cancer Patients

The 5-item version of the International Index of Erectile Function (IIEF-5) and ejaculation function are used to assess sexual function. the IIEF-5 total score ranged from 1 to 25, with a lower score indicating more severe erectile dysfunction, male sexual dysfunction was defined as the IIEF-5 score ≤11points. Ejaculation function was classified as: Grade I, normal ejaculation; Grade II: retrograde ejaculation; Grade III: anejaculation, and ejaculation dysfunction was identified as ejaculation function of grade II/III.

The International Prostate Symptom Score (IPSS) are used to assess urinary function. the IIEF-5 total score ranged from 0 to 35, with a higher score indicating more severe erectile dysfunction,moderate-to-severe urinary dysfunction was defined as the IPSS score \>8 points.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS	NCT03520088	Rectal Cancer	Inferior mesent... Inferior mesent...	18 Years - 100 Years	Corporacion Parc Tauli
Urinary and Sexual Dysfunctions Evaluation After Rectal Resection	NCT04404673	Rectal Cancer	Evaluation of u...	18 Years -	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Obstruction of Malignancy: Percutaneous Renal vs Endoscopic Stent	NCT05640115	Cancer Urinary Obstruc... Malignancy Urinary Dysfunc... Ureter Obstruct... Ureter Injury	Ureteral Stent Percutaneous Ne...	18 Years -	University of Chicago
The OPERa Study: Evaluating QoL After Rectal Cancer Surgery	NCT04893876	Rectal Cancer Quality of Life Bowel Dysfuncti... Sexual Dysfunct... Urinary Dysfunc... Emotional Distr... Surgery		18 Years -	Jewish General Hospital
Multicenter Study on Postoperative Urinary and Sexual Function During Laparoscopic Functional Total Mesorectum Excision	NCT05049317	Rectal Cancer	Laparoscopic FT...	18 Years - 70 Years	Renmin Hospital of Wuhan University

Spots Global Cancer Trial Database for urinary dysfunction