Complication Clinical Trial
Official title:
Randomized Pilot Study to Improve Postprostatectomy Incontinence and Potency by Application of Dried Human Amnion Graft
The investigators present a randomized trial of patients undergoing placement of dehydrated human amnion membrane (dHAM) around the neurovascular bundle (NVB) and vesicourethral anastomosis (VUA) during radical retropubic prostatectomy (RRP) in a tertiary center in Germany.
Patients suffer under incontinence and impotence after RRP, improving techniques and studies are missing. The human amniotic membrane includes growth factors and unique immune tolerance which can improve tissue regeneration. The preliminary studies could prove the potential value of dHAM in the reconstruction of the urinary tract and nerve protection. The investigators initially present a randomized trial to improve postoperative continence and potency of patients undergoing placement of dehydrated human amnion membrane (dHAM) around the neurovascular bundle (NVB) and vesicourethral anastomosis (VUA) during RRP for the treatment of prostate cancer. RRP is performed in a standardized way by one experienced surgeon. The patients are randomized 1:1 to dHAM vs. placebo and blinded during the study period. The primary outcome is a postoperative continence measure as 24hrs pad test up to 12mos postoperatively. Secondary outcomes are potency, insufficiency of VUA, postoperative complications and biochemical recurrence. Using the T-test with an alpha of 0.05 and a power of 80% and expecting a drop-out of 20% of the patients, an adjusted sample size per arm of 164 patients is required. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT04576234 -
Comparative Study Between Two Routes of Enteral Feeding
|
N/A | |
| Completed |
NCT01823328 -
Ketamine Versus Etomidate for Rapid Sequence Intubation
|
Phase 4 | |
| Recruiting |
NCT05428618 -
Mobile Application for Bariatric Surgery Patients
|
N/A | |
| Completed |
NCT05710796 -
AN OBSERVATIONAL STUDY ON CARDIOVASCULAR INVOLVEMENT IN COVID RECOVERED PATIENTS
|
||
| Recruiting |
NCT04921540 -
Ingrown Toenails : Surgery Only Versus Surgery + Chemical Cauterization With TCA
|
N/A | |
| Completed |
NCT05770583 -
The Effectiveness of FiO2 Titration Guided by the Oxygen Reserve Index in Preventing Hyperoxia.
|
N/A | |
| Recruiting |
NCT04037995 -
Real World Study of End-stage Liver Disease in China
|
||
| Completed |
NCT04256590 -
Tongue Depressor-related Tongue Swelling
|
||
| Active, not recruiting |
NCT03776591 -
Open D3 Right Hemicolectomy Compared to Laparoscopic CME for Right Sided Colon Cancer
|
N/A | |
| Completed |
NCT03708874 -
Pain Management of Emergency Laparoscopic Cholecystectomy in Patients With Acute Cholecystitis
|
||
| Completed |
NCT02937610 -
Percutaneous Endoscopic Gastrostomy in Hands of ORL-HN Surgeon
|
N/A | |
| Completed |
NCT01519362 -
A Woman Suffered From Leukocytopenia and Widespread Migration After Polyacrylamide Hydrogel (PAAG) Injection in Epicranial Aponeurosis
|
N/A | |
| Completed |
NCT04487509 -
Incidence Study on Acute Coronary Disease With ST Segment Elevation
|
||
| Terminated |
NCT05518474 -
Self-proning and Repositioning in COVID-19 Outpatients at Risk of Complicated Illness
|
N/A | |
| Recruiting |
NCT03716089 -
Comparison of Tumor Efficacy Safety in Laparoscopic Resection of Gastrointestinal Stromal Tumors Between Favorable and Unfavorable Site
|
||
| Active, not recruiting |
NCT04443465 -
Patient Experiences of IONM and Outcomes
|
||
| Active, not recruiting |
NCT03865537 -
Cold Snare Endoscopic Mucosal Resection Trial
|
N/A | |
| Active, not recruiting |
NCT03860090 -
Efficacy and Safety in Pacemaker and Defibrillator Implantation Via Cephalic Versus Axillary Vein Access (CEPHAX)
|
N/A | |
| Recruiting |
NCT05780775 -
Lipid Balance in Adult Sickle Cell Patients
|
N/A | |
| Completed |
NCT02594891 -
Effect of 8.5 F Plastic Stent Without Proximal Flap on Prevention of Post-ERCP Cholangitis
|
N/A |