Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Colorectal Neoplasms

Crohn Disease

Polyps

Inflammatory Bowel Diseases

Intestinal Diseases

Gastroenteritis

Gastrointestinal Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Colonic Diseases

Rectal Diseases

Control group using a hemodynamic standard protocol

Hemodynamic optimization using Photoplethysmography device (ClearSight, Edwards Lifesciences, Irvine, CA)

Use Photoplethysmography for hemodynamic optimization during colorectal perioperative period

Photoplethysmography

Anne-Lise Fiant, MD

The purpose of this study is to determine whether hemodynamic optimization with photoplethysmography (ClearSight, Edwards Lifesciences, Irvine, CA) during colorectal surgery could decrease the incidence of perioperative complications.

All patients received the photoplethysmography monitoring, but the monitor was blinded in the control group.

Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery

Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery : A Randomized Controlled Study

Medico economic evaluation of photoplethysmography use will be assessed with a specific unit of measure, using cost of treatment.

Two independent experts defined the presence of complication using an a priori classification.

University Hospital, Caen

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Hemorrhage

Adenoma

Colonic Polyps

Respiratory Tract Infections

Pathological Conditions, Anatomical

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Polyps

Herbal and Botanical

All Drugs and Chemicals

Cola

Exacto™

Alessandro Repici, MD

Colorectal cancer is a major cause of morbidity and mortality in Western countries. Scientific studies have shown that endoscopic polypectomy is efficacious in preventing CRC incidence and mortality.

Endoscopic polypectomy carries a risk of major complications, such as bleeding or bowel perforation, so that a careful balance between efficacy and safety appears to be clinically relevant.

Most of the polypectomies are performed for diminutive (\<5 mm) or small (6-9 mm) lesions, which represent over 90% of all the polyps.

To minimize the risk of complications when removing \<10 mm polyps, cold-polypectomy techniques - i.e. without electric current - by means of biopsy forceps or snare, have been proposed.

Although the risk of perforation is virtually excluded by cold-polypectomy, the lack of electrocautery may result in an increased risk of bleeding. The safety of cold-snare polypectomy has however been recently shown in controlled trials.

Regarding the efficacy of cold-polypectomy for subcentimetric polyps, very few studies have assessed the post-polypectomy completeness of the removal of polyp tissue (i.e. residual disease), and no studies have compared it to conventional polypectomy.

The investigators perform this study to assess both the efficacy and safety of a novel snare (Exacto™) for polyp removal.

Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Small Colorectal Polyps

Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Subcentimetric Colorectal Polyps: the E-scope (Efficacy and Safety of COld PolypEctomy) Trial

Clinical success, defined as absence of polyp tissue, either hyperplastic or adenomatous, on the margins of the polypectomy area after cold-polypectomy of subcentimetric polyps. Such assessment is performed on two biopsies performed on the polypectomy scar. The investigators will calculate the percentage (%) of complete and incomplete polypectomies with the new device.

Clinical success (as defined in the primary end-point) according to the size class: diminutive (\<5 mm) and small (6-9 mm) polyps.

Post-polypectomy bleeding defined as any bleeding requiring immediate therapeutic endoscopic procedure (i.e. clipping, electrocautery) or delayed treatment, such as hospitalization or new endoscopic procedure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery	NCT02343601	Polyp of Large ... Colorectal Neop... Crohn Disease	Photoplethysmog...	18 Years - 95 Years	University Hospital, Caen
Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery	NCT02343601	Polyp of Large ... Colorectal Neop... Crohn Disease	Photoplethysmog...	18 Years - 95 Years	University Hospital, Caen
Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Small Colorectal Polyps	NCT02245854	Polyp of Large ... Colonic Polyps Colon Nos Polyp... Complications Bleeding	Exacto™	18 Years -	Istituto Clinico Humanitas
Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery	NCT02343601	Polyp of Large ... Colorectal Neop... Crohn Disease	Photoplethysmog...	18 Years - 95 Years	University Hospital, Caen

Spots Global Cancer Trial Database for polyp of large intestine