Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Robot-assisted total mesorectal excision (RTME) for rectal cancer. Two different RTME procedures were chose to personalized patients. Generally, when the tumor located within 5-15cm from the anal verge, low anterior resection (LAR) was employed, and tumor located below 5cm, abdominoperineal resection (APR) was applied usually.

Traditional laparoscopic total mesorectal excision (LTME) for rectal cancer was performed. The Urinary, sexual function and sphincter- preservation outcomes were evaluated.

The Da Vinci Surgical System may help to protect subtle anatomical structure and provide more functional protection when compared to laparoscopic surgery. This study aimed to compare RTME and laparoscopic total mesorectal excision (LTME) for rectal cancer with regard to Urinary, sexual function and sphincter- preservation outcomes.

robot-assisted total mesorectal excision

Traditional laparoscopic total mesorectal excision (LTME) for rectal cancer.

laparoscopic total mesorectal excision

This study compared robot-assisted total mesorectal excision (RTME) and laparoscopic total mesorectal excision (LTME) with regard to urinary function, sexual function and sphincter- preservation outcomes for low rectal cancer.

Urinary and sexual dysfunction are recognized complications of rectal cancer surgery in men. This study compared robot-assisted total mesorectal excision (RTME) and laparoscopic total mesorectal excision(LTME) with regard to these functional outcomes.Sphincter- preservation outcomes for low rectal cancer was observed as well.

Trial of Robotic Versus Laparoscopic-assisted Radical Resection for Rectal Cancer

A Randomized, Prospective Trial of Robotic Versus Laparoscopic-assisted Radical Resection for Rectal Cancer in Urinary, Erectile Function and Anal Function

DFS was defined as from the date of randomization to the date of tumor recurrence or death from any cause

Southwest Hospital, China

Principal Investigator

Behaviors and Mental Disorders

Quality of Life

Temporary ileostomy with anal sphincter preservation

Permanent colostomy with total anal sphincter sacrifice

After high ligation of IMA, TME with autonomic nerve preservation, proctectomy with sphincter sacrifice and permanent colostomy.

Abdominoperineal resection

After high ligation of IMA, TME with autonomic nerve preservation, sphincter preservation and proctectomy with distal margin of more than 0.5cm in length and temporary ileostomy

Sphincter preservation surgery

Sung-Bum Kang, Ph. D.

Sphincter preservation surgery in low rectal cancer has been increased due to better understanding of tumor biology and advances in surgical technology. Furthermore, a majority of patients prefer sphincter preservation rather than living with permanent colostomy. But it is not clear whether sphincter preservation is directly related with better quality of life. There have been many studies comparing sphincter preservation surgery and abdominoperineal resection in many aspects including oncologic and functional outcomes, and the quality of life. However, the conclusion remains controversial because of the different results between studies.

This prospective study was designed to compare the quality of life after sphincter saving surgery and abdominoperineal resection. Because of ethical issues, it is difficult to conduct as a randomized trial. On the basis of tumor location, extent, and preoperative anal function, patient will be attributed to two different operative method groups. On the assumption that 10% of the patients are lost to follow-up at 1 year, at least 74 patients undergoing APR and 220 patients undergoing SPS will be recruited. The study will be continued until the target sample size will be achieved.

Comparison of Sphincter Preservation Surgery and Abdominoperineal Resection (APR): Prospective Clinical Trial

Comparison of Sphincter Preservation Surgery Versus Abdominoperineal Resection for Low Rectal Cancer: Prospective Clinical Trial

Measured by EORTC-QLQ C30, CR38 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).

Oncologic outcomes (recurrence, survival)

Measured by IPSS questionnaire at preoperative(baseline)and postoperative(12,24,36 months).

Measured by FSFI,IIEF-5 questionnaires at preoperative(baseline)and postoperative(12,24,36 months).

Only patients with sphincter preservation surgery, measured by manometry and MSKCC questionnaire at preoperative(baseline)and after ileostomy repair (12,24,36 months).

Seoul National University Bundang Hospital

National Cancer Center, Korea

Seoul National University Boramae Hospital

Hallym University Medical Center

Daehang Hospital

Seoul National University Hospital

Director of Colorectal Cancer Center, Principal Investigator, Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Recurrence

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Biopsy proven Prostate Cancer is delimited and defined by MP-MRI. The MRI study is fused with transrectal ultrasound in realtime. The cryogenic "cryoprobes/devices" are employed to freeze and all "circuled or noted" cancer lesions. Two freeze 8 min/ thaw 10 min clycles are performed. Thermocouples are used to monitor treatment areas and safety margins

FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY

CIELO D GUERRA, BS

LUANDA SIANO, PA

FERNANDO J BIANCO, MD

EDWARD L GHEILER, MD

ARIEL M KAUFMAN, MD

EUSEBIO J LUNA, MD

EUSEBIO LUNA, MD

Isabel H Lopez, MD

Registration of Prostate Cancer patients undergoing Prostate Cryotherapy guided by Mutiparametric-MRI (MP-MRI) highlighting biopsy confirmed regions. The primary outcome measure is 5 year oncological control. Secondary aim is lack of progression beyond the prostate gland. The aim of intervention is to eradicate prostate cancer disease in the treated area while imposing no or minimal deleterious effects in quality of life.

CLINICAL TRIAL OF OBSERVATION NATURE

PRIMARY OUTCOME

Cancer control of treated areas 5, 10, 15 years after intervention based on prostate biopsy of initial treated area, progression requiring conversion to radical prostate surgery or radiation or other forms of whole gland treatment (ej, HIFU), Metastatic Free survival: CT Scan and Bone Scans, Cancer-Specific and Overall Survival

SECONDARY OUTCOMES

Secondary Interventions focal interventions due to de-novo lesions. Focal or target therapy rescue with other technologies (ej HIFU); Short, Intermediate and Long-Term Urinary and Sexual Function changes in quality of life measured by validated inventories; Anxiety related to cancer and cancer control. Treatment tolerance to local anesthesia. Patient App compliance and activity to monitor care

DATA COLLECTION

* Complete H\&P, family history, past medical and surgical history, social history, allergies, and medications
* As of July 2016, voluntary measurement thru Focalyx App for smartphones and tablets
* Imaging Specifics Assessing Prostate, Seminal Vesicles and Urethral Contouring by Multi-parametric-MRI. Dominant lesions and secondary lesions contouring my MP-MRI.
* Procedure specific Co-Registration quality with ultrasound denoting quality
* Specific ablative description and digitalization of critical measures such as: ablation type (ej cryotherapy, equipment used) procedure, cryoprobes used, freeze/thaw cycles timing, temperatures at neurovascular bundles, denonvilliers fascia. Urethral warmer requirements
* Follow up information: 30 day perioperative outcomes (incidence of UTI, urinary retention, failure of local anesthetic, pain measures). 6 week, 3,6,9,12 month and then every 6 month measures of PSA, Testosterone levels, Urinary Function and Sexual Function inventories, Overall anxiety and regret related to diagnosis and treatment
* Uroflow and PVR measurements by 3 to 6 month of treatment
* MP MRI on a yearly basis, for years 2,3,4 after treatment, biopsy driven by new suspicious MRI findings
* MP MRI triggered by elevation in PSA velocity or PSA level 10% above diagnosis
* Transperineal Fusion Guided Prostate biopsy at 1st year - emphasis on treated areas, suspicious MRI areas
* Transperineal Fusion Guided Prostate biopsy at 5th year - emphasis on treated areas, suspicious MRI areas
* 5, 10, 15 Yr CT Scans, PET Scan/Bone Scan

SAFETY MEASURES

* Periodic evaluation of registry to ensure consistency in follow up
* Patient remainders of tests required

MRI/Ultrasound Fusion Guided Prostate Cryotherapy

Office Based MRI/Ultrasound Guided Prostate Cryotherapy: Outcomes Registry

Non identifiable pertinent information will be shared for other scientists to evaluate other pertinent questions

Type of treatments required after initial intervention over time

Lack of prostate cancer presence in treated area after MRI/US FUSION Biopsy

Lack of prostate cancer presence in the gland after MRI/US FUSION Biopsy

Lack of prostate cancer presence in gland measured by MP-MRI

Evaluation of urinary function outcomes when compared to baseline using expanded prostate composite index and AUA symptoms scores. Urinary function also by objective measurements - uroflow and post void residuals

Procedure tolerance, need for hospital admission or ER consultation, incidence of urinary tract infection, urinary retention, any significant side effect that may occur and perioperative survivel

Evaluation of sexual function outcomes when compared to baseline using Sexual Inventory for men questionnaires

Urological Research Network, LLC

Urinary Incontinence

Fecal Incontinence

Enuresis

Urination Disorders

Urologic Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Lower Urinary Tract Symptoms

Urological Manifestations

Questionnaire send by post at 3, 6, 12, 18 and 24 months after operation

Structured Rehabilitation program

Rolv-Ole Lindsetmo, MD, Phd, Mph

Quality of life after rectal surgery is reported to be impaired. Side effects of surgery and/or neoadjuvant treatment as functional disturbances like sexual dysfunction, urinary incontinence, anal incontinence or stoma problems are commonly experienced. The investigators hypotheses is that structured rehabilitation program addressing these problems will improve quality of life. A RCT are performed in order to document the effects of the rehabilitation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial of Robotic Versus Laparoscopic-assisted Radical Resection for Rectal Cancer	NCT02673177	Rectal Neoplasm...	robot-assisted ... laparoscopic to...	18 Years - 70 Years	Southwest Hospital, China
Comparison of Sphincter Preservation Surgery and Abdominoperineal Resection (APR): Prospective Clinical Trial	NCT01461525	Rectal Cancer	Abdominoperinea... Sphincter prese...	20 Years - 80 Years	Seoul National University Hospital
MRI/Ultrasound Fusion Guided Prostate Cryotherapy	NCT02381990	Neoplasms Prost... Cancer of the P...	FUSE IMAGE MRI ...	55 Years -	Urological Research Network, LLC
Effects of Structured Rehabilitation Program on Quality of Life in Rectal Cancer Patients- a Randomized Controlled Trial	NCT00895388	Quality of Life Sexual Function Urinary Inconti... Anal Incontinen...	Structured Reha...	18 Years - 75 Years	University Hospital of North Norway
MRI/Ultrasound Fusion Guided Prostate Cryotherapy	NCT02381990	Neoplasms Prost... Cancer of the P...	FUSE IMAGE MRI ...	55 Years -	Urological Research Network, LLC
Comparison of Sphincter Preservation Surgery and Abdominoperineal Resection (APR): Prospective Clinical Trial	NCT01461525	Rectal Cancer	Abdominoperinea... Sphincter prese...	20 Years - 80 Years	Seoul National University Hospital

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