Neoplasms

Digestive System Diseases

All Conditions

Behaviors and Mental Disorders

Rectal Neoplasms

Fecal Incontinence

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

Side-to-End Anastomosis as neorectal reconstruction technique in low anterior resection (LAR)

Transverse Coloplasty pouch as neorectal reconstruction technique in low anterior resection (LAR)

During the scheduled low anterior resection (LAR) in patients with distal rectal cancer and anticipated anastomosis in the mid or distal rectal third, the reconstruction phase of the LAR consists of the implementation of a side-to-end colorectal anastomosis.

Side-to-End Anastomosis

During the scheduled low anterior resection (LAR) in patients with distal rectal cancer and anticipated anastomosis in the mid or distal rectal third, the reconstruction phase of the LAR consists of the implementation of a transverse coloplasty pouch. For this purpose an end-to-end colorectal anastomosis is initially performed, followed by a longitudinal incision of approx. 8-10 cm length proximal of the anastomosis and a subsequent transverse suture in terms of the coloplasty technique.

Transverse Coloplasty

Markus Rentsch, MD

Sandro M Hasenhütl, MD

Andreas Hölscher, MD

Carolin Orlitsch, MD

Johann Spatz, MD

CSAR Trial's aim is to determine whether the transverse coloplasty pouch or the side-to-end anastomosis as rectal reservoir reconstruction offers the best functional results.

This study directly compares two neorectal reservoir-techniques, the transverse coloplasty and the side-to-end anastomosis, in low anterior resection in distal rectal cancer for the first time. Its focus is on the functional results. Besides stool frequency, the quality of life, safety of the procedures and the usage of stool modulating drugs is monitored in an 12 months-follow up regime.

Study participants will be randomized in two parallel study arms regarding their neorectal reconstruction in low anterior resection, the experimental arm using the side-to-end anastomosis and the control group using the transverse coloplasty technique.

Transverse Coloplasty vs. Side-to-end Anastomosis Following Low Anterior Resection (LAR): CSAR Trial

There is no plan to make individual participant data available to third parties beyond the study team.

Between group differences in stool frequency at t = 6 months postoperative

* Septic intraabdominal complications related to anastomosis (anastomotic insufficiencies, suture insufficiencies, abscesses);
* Wound infection

Quality of Life with focus on colorectally specialized questionnaires

Usage of antimotility drugs (e.g. loperamide) evaluated by standardized questionnaires

Ludwig-Maximilians - University of Munich

Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Hao Chen

Jian Huang, MD

The clinical trial assesses the effect of urinary indwelling time on early continence after robot- assisted radical cystectomy with orthotopic ileal neobladder.

Radical cystectomy is the gold standard for muscle-invasive bladder. Orthotopic ileal neobladder, as one of the urinary diversion methods, is preferred whenever possible to achieve a better postoperative quality of life. After surgery, the patient usually indwells a catheter until the anastomotic site heals. And the urinary indwelling time may have an effect on early continence. This is a prospective study including patients undergoing RARC with orthotopic ileal neobladder. Urinary continence recovery and perioperative complication will be analyzed.

Effect of Urinary Indwelling Time on Early Continence After Robot-assisted Radical Cystectomy With Orthotopic Ileal Neobladder.

First Affiliated Hospital, Sun Yat-Sen University

Third Affiliated Hospital, Sun Yat-Sen University

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Adenocarcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy (VIP) techniques

Multi-port transperitoneal RARP with bilateral intrafascial nerve-sparing techniques

Patients with localized prostate cancer are randomized into this group in a 1:1 ratio and receive single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniques. The investigators will monitor patients for perioperative data recording, treatment and 1-year follow-up.

Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniques

Patients with localized prostate cancer are randomized into this group in a 1:1 ratio and receive multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques. The investigators will monitor patients for perioperative data recording, treatment and 1-year follow-up.

Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques

Shancheng Ren, MD/PhD

Yi fan Chang

Shancheng Ren, PhD

This study is a two-arm, multicenter, randomized controlled clinical trial on whether single-port extraperitoneal VIP RARP is non-inferior to multi-port transperitoneal RARP in terms of functional recovery rate and other key metrics.

Multicenter enrollment of 480 patients with localized prostate cancer meeting enrollment criteria are randomized to undergo either single-port robotic extraperitoneal VIP radical prostatectomy or multi-port robotic transperitoneal bilateral intrafascial radical prostatectomy for perioperative data recording, treatment, and monitoring with 1 year follow up.

Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)

Potency recovery rate 3 months postoperatively, based on the patient's description of whether the erection is firm enough for sexual activity or intercourse.

The rate of recovery of continence postoperatively, measured in the number of pads used per day.

PSA status postoperatively，measured in ng/mL

Potency recovery rate will be assessed by patient's self-reported erectile firmness for sexual activity or intercourse, International Index of Erectile Dysfunction(IIEF-5) score（from 0-25 score, a higher score means a worse outcome）, and phosphodiesterase5 (PDE-5）inhibitor intake frequency according to patients' despciption (a higher intake means a worse outcome）.

Clavien-Dindo complication score measured in the following grades（a higher grade means a worse outcome） ： First grade：complications that do not require medication, surgery or endoscopic treatment.

Second grade： complications require to be treated with drugs, including blood transfusion and parenteral nutrition.

Third grade： complications that require surgery, endoscopy, or radiation therapy.

Fourth grade: the emergence of life-threatening complications, including cerebral hemorrhage, etc., which is also divided into 4a and 4b, 4a is single-organ dysfunction, 4b is mainly multi-organ dysfunction and injury.

Fifth grade: death.

Time elapsed from skin incision to placement of the final skin suture, measured in minutes

Estimated blood loss, measured in volume (mL)

Number of additional ports needed in surgery

Hospital stay, counted in days from the first day of hospitalization to discharge

Hospital stay, counted in days from the time of transfer to the post anesthesia care unit (PACU) to discharge

Shanghai Zhongshan Hospital

ShuGuang Hospital

The Third Affiliated Hospital of Naval Medical University

The First Affiliated Hospital of Guangzhou Medical University

Sir Run Run Shaw Hospital

Sichuan Provincial People's Hospital

Shanghai Changzheng Hospital

Professor，Chief of Urology

robot-assisted laparoscopic prostatectomy

conventional laparoscopic radical prostatectomy

Comparison of robotic-assisted and conventional laparoscopic radical prostatectomy

Prostatectomy

Jens-Uwe Stolzenburg, Prof.

This randomized trial was designed to address the lack of high-quality literature comparing robotic-assisted (RARP) and laparoscopic (LRP) radical prostatectomy (RP).

Purpose: The LAP-01 trial compares outcomes between RARP and LRP.

LAP-01 is the first multicenter, prospective randomized, patient-blinded controlled trial comparing robotic-assisted and conventional laparoscopic radical prostatectomy.

The investigation include an extensive evaluation of clinical, oncological, functional and quality of life related data by means of validated patient-reported outcome measures.

The primary outcome is the assessment of time to continence restoration at 3 months. This is evaluated by an assessment of a pad diary completed daily by each patient from the time of catheter removal until restoration of continence. Secondary endpoints include continence and erectile function, as well as quality of life (EORTC-QLQ-C30, EORTC-QLQ-PR25), patient satisfaction and Hospital Anxiety and Depression Scale (HADS) at 1, 3, 6 and 12 months after surgery in addition to oncological outcomes up to 3 years follow-up.

With 782 enrolled patients it is the largest trial carried out till date on this topic.

Patients were blinded with respect to the surgical method until the end of the 3-month evaluation and extraction of the primary study outcome.

Laparoscopic vs Robotic-Assisted Radical Prostatectomy

A Multicenter Randomized Study to Investigate the Outcomes of Laparoscopic and Robotic-assisted Radical Prostatectomy

The primary outcome is continence recovery at 3 months based on the patient's pad diary; RARP vs. LRP

Erectile function questionnaire (including IIEF-5 questionnaire) and information on supportive medication for erection

Health-related quality of life questionnaire (EORTC QLQ-C30). Raw scores are linearly transformed into a 0-100 point scale. High global health status and functioning scores indicate good QoL, whereas elevated symptom scores represent a high level of symptomology and therefore impaired QoL.

Prostate-specific quality of life questionnaire (EORTC QLQ-PR25). Raw scores are linearly transformed into a 0-100 point scale. High functioning scores indicate good QoL, whereas elevated symptom scores represent a high level of symptomology and therefore impaired QoL.

The Hospital Anxiety and Depression Scales (HADS-D)

Patient satisfaction is measured on a 5-point scale ranging from highly dissatisfied to highly satisfied. Additionally, patients are asked if they would in hindsight make a decision for or against the surgery and if they would advise a friend to undergo surgery under the same circumstances.

Klinikum Dortmund

University Hospital Heidelberg

Heinrich-Heine University, Duesseldorf

University of Leipzig

Prof.

Erectile Dysfunction

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Coagulants

All Drugs and Chemicals

Hemostatics

Thrombin

Nerves-paring during robotic-assisted laparoscopic prostatectomy is conducted without mono- or bipolar electrocautery and clipping by using a hemostatic gelatine-thrombin matrix.

Nerve-sparing during robotic-assisted radical prostatectomy is conducted with the use of mono- and bipolar electrocautery and surgical clipping.

Hemostatic gelatin-thrombin matrix is used for hemostasis during nerve-sparing dissection of the prostate.

Application of a hemostatic gelatin-thrombin matrix

Mono- and bipolar electrocautery and surgical clips are used for hemostasis during nerve-sparing dissection of the prostate.

Use of mono- and bipolar electrocautery and surgical clips

Axel Haferkamp, Prof.

Michael A Reiter, Dr.

The purpose of this study is to evaluate the use of a hemostatic gelatine-thrombin matrix during athermal nerve-sparing prostate resection compared to conventional hemostasis using electrocautery in patients with localized prostate cancer and to investigate effects on postoperative erectile function and continence.

Athermal Nerve-sparing During Robotic-assisted Radical Prostatectomy Using a Hemostatic Matrix.

Prospective Randomized Investigation of Athermal Nerve-sparing During Robotic-assisted Laparoscopic Prostatectomy Using a Hemostatic Gelatin-thrombin Matrix

Postoperative erectile function compared to preoperative status assessed validated questionnaires.

Postoperative continence compared to preoperative status assessed by validated questionnaires.

Amount of blood collected in the suction during surgery.

Intra- and postoperative complications associated to the study´s intervention.

Johann Wolfgang Goethe University Hospital

Prof. Dr. med. Axel Haferkamp

Nervous System Diseases

Wounds and Injuries

Peripheral Nerve Injuries

Peripheral Nervous System Diseases

Neuromuscular Diseases

Trauma, Nervous System

Implantation of appropriate length of processed human nerve scaffold at the time of surgery.

Processed Human Nerve Tissue Scaffold

Joseph J Smith, MD

The purpose of this study is to determine if it is technically feasable to repair nerves that are injured as part of a planned surgical removal of the prostate and the surrounding tissue in subjects with prostate cancer. The study will also examine the long term outcomes on erectile function, continence and overall quality of life in the enrolled subjects.

Study of Nerve Reconstruction Using AVANCE in Subjects Who Undergo Robotic Assisted Prostatectomy for Treatment of Prostate Cancer

A Pilot Study to Assess the Technical Feasibility of Robotic Assisted Laparoscopic Interpositioning of the AVANCETM Nerve Graft for Reconstruction of the Neurovascular Bundle, With a Twenty-four Month Follow-up Term to Assess Efficacy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Transverse Coloplasty vs. Side-to-end Anastomosis Following Low Anterior Resection (LAR): CSAR Trial	NCT03074461	Rectal Cancer Rectal Neoplasm... Rectal Tumors Fecal Incontine...	Side-to-End Ana... Transverse Colo...	18 Years -	Ludwig-Maximilians - University of Munich
Effect of Urinary Indwelling Time on Early Continence After Robot-assisted Radical Cystectomy With Orthotopic Ileal Neobladder.	NCT04966130	Muscle-Invasive...		18 Years - 80 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)	NCT06238713	Prostate Adenoc... Localized Prost...	Single-port ext... Multi-port tran...	18 Years - 75 Years	Shanghai Changzheng Hospital
Laparoscopic vs Robotic-Assisted Radical Prostatectomy	NCT03682146	Prostate Cancer	Prostatectomy	18 Years - 75 Years	University of Leipzig
Athermal Nerve-sparing During Robotic-assisted Radical Prostatectomy Using a Hemostatic Matrix.	NCT01448798	Prostate Cancer Erectile Dysfun...	Application of ... Use of mono- an...	18 Years -	Johann Wolfgang Goethe University Hospital
Transverse Coloplasty vs. Side-to-end Anastomosis Following Low Anterior Resection (LAR): CSAR Trial	NCT03074461	Rectal Cancer Rectal Neoplasm... Rectal Tumors Fecal Incontine...	Side-to-End Ana... Transverse Colo...	18 Years -	Ludwig-Maximilians - University of Munich
Athermal Nerve-sparing During Robotic-assisted Radical Prostatectomy Using a Hemostatic Matrix.	NCT01448798	Prostate Cancer Erectile Dysfun...	Application of ... Use of mono- an...	18 Years -	Johann Wolfgang Goethe University Hospital
Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)	NCT06238713	Prostate Adenoc... Localized Prost...	Single-port ext... Multi-port tran...	18 Years - 75 Years	Shanghai Changzheng Hospital
Study of Nerve Reconstruction Using AVANCE in Subjects Who Undergo Robotic Assisted Prostatectomy for Treatment of Prostate Cancer	NCT00953277	Peripheral Nerv... Prostate Cancer Radical Prostat... Nerve Reconstru... Cavernous Nerve...	Processed Human...	18 Years - 70 Years	Axogen Corporation

Spots Global Cancer Trial Database for continence

Every month we try and update this database with for continence cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for continence

Every month we try and update this database with for continence cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for continence cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.