Rectal Neoplasms Clinical Trial
Official title:
Uni-center, Patient-blinded, Randomized, 12 Month, Parallel-group, Non-inferiority Study to Compare Outcomes of Three-row Versus Two-row Circular Staplers for Colorectal Anastomosis Formation After Low Anterior Resection for Rectal Cancer
This trial aims to assess safety and efficacy of three-row circular staplers compared to two-row surgical stapllers in short-term and long-term perspective in patients with rectal cancer undergoing low anterior resection with stapled colorectal anastomosis. All the patients will undergo a low anterior resection. In a half of patients a colorectal anastomosis will be created with a three-row surgical circular stapler. In another half of patients a colorectal anastomosis will be created with a two-row surgical circular stapler.
A low anterior resection for rectal cancer in most cases results in creating a colorectal
anastomosis with a surgical circular stapler device. Using a disposable circular stapler with
two rows of staples is standard of care nowadays. Colorectal anastomosis dehiscence and
subsequent anastomotic leak in postoperative period happens in 5-25% of cases and is a major
and life-threatening complication. Thus different improvements to the procedure of creating a
colorectal anastomosis are being proposed. One of them is utilizing a three-row instead of a
two-row surgical circular stapler.
A three-row surgical stapler has recently been registered and approved for clinical use in
Russia. The primary purpose of this study is to find out the rate of colorectal anastomosis
leakage when using a three-row circular stapler and to demonstrate that it is at least not
bigger than the rate of colorectal anastomosis leakage when using a two-row circular stapler.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02537340 -
PET/MR for Staging Rectal Cancer Patients With and Without EMVI-MR
|
||
Recruiting |
NCT02565667 -
A Prospective Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler
|
N/A | |
Terminated |
NCT02538913 -
Exercise Training for Rectal Cancer Patients
|
N/A | |
Not yet recruiting |
NCT02439086 -
Prediction of Response to Neoadjuvant Therapy in Rectal Cancer
|
N/A | |
Completed |
NCT02233374 -
Predicting RadIotherapy ReSponse of Rectal Cancer With MRI and PET
|
N/A | |
Completed |
NCT00535041 -
Pilot Trial of Pre-operative Chemo/RT Using Xeloda and External Beam RT Followed by Definite Surgery in Patients With Localized Rectal CA
|
N/A | |
Completed |
NCT00535652 -
Concentration of Ertapenem in Colorectal Tissue
|
Phase 4 | |
Recruiting |
NCT04949646 -
Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision
|
N/A | |
Recruiting |
NCT04095468 -
Organ-preserving Management in Patients With Complete or Near-complete Tumour Response After Preoperative Radio(Chemo)Therapy for Rectal Cancer
|
||
Recruiting |
NCT06017583 -
Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With SIB-IMRT in the Treatment of Locally Advanced Rectal Cancer
|
Phase 3 | |
Recruiting |
NCT05689775 -
Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
|
||
Recruiting |
NCT04006951 -
Development of a Clinical and Biological Database in Rectum Cancer
|
N/A | |
Recruiting |
NCT05068180 -
Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients
|
Phase 4 | |
Recruiting |
NCT03714490 -
MRI Simulation-guided Boost in Short-course Preoperative Radiotherapy for Unresectable Rectal Cancer
|
Phase 2 | |
Recruiting |
NCT03325361 -
The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage Anastomotic Leakage
|
N/A | |
Completed |
NCT02252250 -
Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer
|
N/A | |
Completed |
NCT04455737 -
Ex Vivo Intra-arterial Indigo Carmine Injection After Transanal Total Mesorectal Excision
|
||
Completed |
NCT01816607 -
Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness
|
||
Completed |
NCT01721785 -
Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer
|
N/A | |
Active, not recruiting |
NCT01171300 -
Assessment of Response Before, During and After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients
|
N/A |