Clinical Trials Logo
  1. Home
  2. Rectal Neoplasms
  3. NCT03910699

THREE-row Circular STAPLER in Low Anterior Resection for Rectal Cancer — THREESTAPLER  

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03910699
Study type Interventional
Source Russian Society of Colorectal Surgeons
Contact Inna Tulina, MD
Phone +7 (926) 408-66-72
Email tulina@kkmx.ru
Status Recruiting
Phase N/A
Start date April 10, 2019
Completion date October 1, 2020
View Details
See also
  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
Not yet recruiting NCT02439086 - Prediction of Response to Neoadjuvant Therapy in Rectal Cancer N/A
Terminated NCT02538913 - Exercise Training for Rectal Cancer Patients N/A
Completed NCT02233374 - Predicting RadIotherapy ReSponse of Rectal Cancer With MRI and PET N/A
Completed NCT00535652 - Concentration of Ertapenem in Colorectal Tissue Phase 4
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
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 NCT01816607 - Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness
Completed NCT04455737 - Ex Vivo Intra-arterial Indigo Carmine Injection After Transanal Total Mesorectal Excision
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