Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to determine:

1. What quantity of bacteria is spilled into the abdomen during a colon resection

2. If there is a correlation between the quantity and post-operative infection

3. What intralumenal pressure is generated when testing the colonic anastomosis for air leak


Clinical Trial Description

The acceptance and advancement of natural orifice translumenal endoscopic surgery (NOTES) has forced investigators to challenge many firmly accepted surgical practices. The most obvious one being: violating a remote hollow viscous that is uninvolved in the desired surgical intervention. This of course brings into question (1) "How much peritoneal contamination can be tolerated without raising infection risk?" and (2) "How will one repair this intended visceral injury?" This study is intended to bring to light what has been done in animal models, and further, how it will translate in to the now more important human arena.

In this study, patients who are undergoing an elective colectomy will be investigated to quantify what amount of peritoneal contamination is tolerated despite rare abscess formation occurring. Subject will undergo peritoneal washings before and after colonic resection to measure the bacterial load spilled. This data would be beneficial to support that patients who are undergoing a NOTES procedure can and will be able to tolerate a definite quantity of bacterial contaminate. Furthermore, by observing the exact values of peritoneal contamination present there may be a certain level to which infectious complication are more likely to occur. This may provide some insight in NOTES as to when patients may benefit post-operatively from a prophylactic course of antibiotic therapy in response to their higher than tolerable intra-peritoneal bacterial load.

The other component to this study will be to challenge how investigators are examining closure devices in the animal model. Many researchers, including authors of this protocol, have utilized bursting pressure as an objective test to assess the integrity of a completed closure. Current surgical practice uses the insufflation of an endoscope or even a bulb syringe to test for leak of a colonic anastomosis. We intend to measure the pressures that are achieved in a clinical setting to determine the bursting pressures that are required to assess NOTES closure and eliminate the likely unsupported value being placed on a higher bursting pressure commonly quoted in NOTES closure studies. ;


Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01102725
Study type Observational
Source University Hospital Case Medical Center
Contact
Status Completed
Phase N/A
Start date April 2010
Completion date June 2011

See also
  Status Clinical Trial Phase
Completed NCT02503696 - Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD) N/A
Terminated NCT01119027 - Assessing Effectiveness of Laparoscopic Colorectal Surgical Skills N/A
Completed NCT01063231 - Evaluation of PillCamâ„¢ Colon 2 in Visualization of the Colon Phase 3
Completed NCT04074577 - Computer Aided Detection, Tandem Colonoscopy Study N/A
Not yet recruiting NCT04087824 - Deep Learning Algorithm for Recognition of Colonic Segments. N/A
Completed NCT03559543 - Evaluation of Ocoxin®-Viusid® in Metastatic Colorectal Adenocarcinoma Phase 2
Terminated NCT02503631 - Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers
Completed NCT01600209 - Exact CRC Screening Test: Stool Sample Collection Study to Support Assay Validation Testing N/A
Completed NCT01260168 - Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies N/A
Completed NCT00604162 - PillCamâ„¢ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon Phase 3
Recruiting NCT04598880 - Comparison of 1 Liter PEG With Ascorbate and Sodium Picosulfate / Magnesium Citrate for High Quality Colon Cleansing Phase 4
Completed NCT01738425 - A Clinical Phase I Study on GIC-1001 in Healthy Volunteers Phase 1
Completed NCT04080843 - Anlotinib Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF Wild-type mCRC Patients Phase 2
Terminated NCT04644315 - A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors Phase 2
Completed NCT02291445 - Comparing a 182mg Colon-targeted-delivery Peppermint Oil Capsule (Tempocol-ColoPulse®) and a 182mg Enteric-coated Peppermint Oil Capsule (Tempocol®), a Pharmacokinetic Study Phase 2
Completed NCT03037385 - Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors Phase 1/Phase 2
Completed NCT03139942 - Optical Polyp Testing for In Vivo Classification N/A
Completed NCT04263818 - Endoscopist and Endoscope Motions During Colonoscopy N/A
Recruiting NCT05923918 - A Study to Evaluate Safety and Efficacy of PBK_M2101 Phase 3
Completed NCT02647866 - Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis Phase 2