Digestive System Diseases

All Conditions

Symptoms and General Pathology

Crohn Disease

Colitis

Colitis, Ulcerative

Ulcer

Diverticulitis

Colonic Polyps

Polyps

Gastrointestinal Diseases

Intestinal Diseases

Inflammatory Bowel Diseases

Gastroenteritis

Pathological Conditions, Anatomical

Diverticulum

Diverticular Diseases

Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care versus Either Colloid and Crystalloid

Hextend

Lactated Ringers

Anthony Senagore, MD

The purpose of this study is to find out if guided fluid administration with the esophageal monitor is superior to standard fluid administration and whether use of the hetastarch or lactated ringers offers different benefits with respect to length of stay in the hospital after hand-assisted colorectal surgery.

An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy

A Randomized Prospective Double Blind Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care Versus Either Colloid and Crystalloid

Deltex Medical, Inc.

Spectrum Health Hospitals

Dr. Anthony Senagore

Neoplasms

Rectal Neoplasms

Intestinal Polyps

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Rectal Diseases

Treatment of rectal lesions with UNI-VEC

Ariadna Camps, Biomedical engineering

Carlos Álvarez, Medicine

Salvadora Delgado, Medicine

José F Noguera, Medicin

José F Noguera, Medicine

Alba Gómez, Medicine

Olga Maseda, Medicine

Raquel Sánchez, Medicine

Marta Jiménez, Medicine

Mario Álvarez, Medicine

Pedro Parra, Medicine

Javier Sánchez, Medicine

Blas Flor, Medicine

The aim of the clinical trial is to investigate whether the use of a new multichannel endoscopic transanal access device (named UNI-VEC) is safe and effective in the resection of a rectal polyp or tumor that sits in the distal part of the colon (up to about 20 cm from the anal margin). This is the first study to test the device in humans, after proving its good performance in preclinical development (preclinical development has included functional laboratory tests and an animal trial).

Rectal Tumor Resection Using the UNI-VEC Multichannel Transanal Access Device

The device must allow the removal of polyps with a minimum size of 2 cm (maximum diameter of the removed polyp measured in mm) in the rectum.

Anorectal hemorrhagic events for each patinet will be recorded in a table and the number of events will be counted.

The number of injuries to the anorectal canal and perianal region will be recoreded in a table and then the total number of injuries will be counted.

Anorectal continence will be assesed for each Participant with the Wexner Score

Vecmedical Spain, S.L.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy	NCT00467922	Crohn's Disease Ulcerative Coli... Rectal Cancer Colon Cancer Colon Polyps Rectal Polyps Diverticulitis	Hextend Lactated Ringer...	18 Years - 80 Years	Spectrum Health Hospitals
Rectal Tumor Resection Using the UNI-VEC Multichannel Transanal Access Device	NCT06286956	Rectal Polyp Rectal Polyps Rectal Lesion Sessile Colonic... Pedunculated Co...	Treatment of re...	18 Years -	Vecmedical Spain, S.L.
An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy	NCT00467922	Crohn's Disease Ulcerative Coli... Rectal Cancer Colon Cancer Colon Polyps Rectal Polyps Diverticulitis	Hextend Lactated Ringer...	18 Years - 80 Years	Spectrum Health Hospitals

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