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Clinical Research

CMAS is currently completing a multi-year Randomized Controlled Trial of Laparoscopic Nissen Fundoplication (LNF) versus Proton Pump Inhibitors for Treatment of Patients with Chronic Gastro-Esophageal Reflux Disease (GERD). This study was funded by the Ministry of Health and the Canadian Institue of Health Reasearch.
 
The most recent clinical research program is entitled “Laparoscopic Bariatric Surgery for Treatment of Complicated Type 2 Diabetes in Obese Patients: A Prospective Randomized Controlled Pilot Study”. This study is being embarked upon in collaboration with St. Joseph’s Healthcare and Hamilton Health Sciences. The aim of this study is 1) to evaluate the effectiveness of laparoscopic gastric bypass (LGB), laparoscopic adjustable gastric banding (LAGB), and intensive medical management for the treatment of type II diabetes in obese individuals (BMI >28) with poor glycemic control and significantly impaired quality of life, and 2) to determine the sample size necessary for a subsequent larger randomized controlled trial.
 
COLORECTAL DATABASE
Karen Barlow 905.522.1155 x 35067

Database to study outcomes of colorectal surgery

Inclusion: Any patient who underwent or is undergoing colorectal surgery

IF ELIGIBLE: Discuss database with patient.Give pt CONSENT FORM to read and sign if they agree.

SILS DATABASE
Karen Barlow 905.522.1155 x 35067

Database to study outcomes of SILS

Inclusion: Any patient who underwent or is undergoing SILS

IF ELIGIBLE: Discuss database with patient. Give pt CONSENT FORM to read and sign if they agree.

ENTERIC GLIA STUDY
Karen Barlow 905.522.1155 x 35067

A healthy section of colon resected will be kept in order to study the ability of teniae coli cells to aid repair of injured spinal cords in humans

Inclusion:

· Age > 18
· Scheduled to undergo surgery where a section of colon will be removed

IF ELIGIBLE: Discuss study with patient. (1) Give pt CONSENT FORM to read and sign if they agree. Give consent form to secretary or Karen or (2) give pt information to Surgeon's Secretary or Karen

LAP VS. OPEN RESECTION FOR RECTAL CANCER
Karen Barlow 905.522.1155 x 35067

Multi-centre RCT comparing open to lap-assisted resection for rectal cancer

Inclusion:

· Age >18

· BMI ≤ 34

· Histologic diagnosis of adenocarcinoma of the rectum (<12cm from the anal verge)

· T3N0M0, T1-3N1-2M0 disease as determined by pre-treatment CT scans and pelvic MRI or transrectal ultrasound.

· Completion of pre-operative 5FU-based chemotherapy and/or radiation therapy. (Capecitabine may be substituted for 5FU)

· ECOG (Zubrod) Performance Status < 2

· Non-pregnant and non-lactating

Exclusion:

· T4 disease extending to circumferential margin of rectum or invading adjacent organs

· Conditions that would preclude use of a laparoscopic approach (e.g., multiple previous major laparotomies, severe adhesions)

· Systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude surgery or other severe incapacitating disease

· Concurrent or previous invasive pelvic malignancy within five years prior to registration

· History of psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements

IF ELIGIBLE: Discuss study with pt. If pt agrees, complete: PARTICIPANT ELIGIBILIY CRITERIA FORM and give to Surgeon's Secretary or Karen

CHO DRINK STUDY
Geoff Travis 905.522.1155 x 33362

To study the efficacy and safety of preoperative carbohydrate drink in decreasing the postoperative nausea and vomiting and post-operative dehydration in patients undergoing elective laparoscopic surgery

Inclusion:

· Age 18 – 80

· Scheduled to receive elective laparoscopic surgery

· Hospital stay ≥ 12 hours

· Anesthetist assessed ASA 1-3

Exclusion:

· Previous gastric surgery

· Immunocompromised patient

· Severe GERD

· Delayed emptying

· Liver disease

· Sensitivity/allergy aspartame or acesulfame

IF ELIGILIBE: Discuss study with pt. If pt agrees, give pt information to Surgeon's Secretary or Geoff

MESH REGISTRY
Geoff Travis 905.522.1155 x 33362

Inclusion:

· Age >18

· Scheduled to receive a surgically implanted mesh product for repair of a hernia defect

Exclusion:

· receiving medication for chronic pain

· suffering from chronic depression

· known or suspected of current substance abuse

· terminal illness

· multiple hernia repair requiring more than one mesh device EXCEPT: bilateral inguinal or femoral hernia repair operated on the same

· requiring concomitant surgical procedure

· patient suffering from ongoing infection

IF ELIGILIBE: Discuss registry with pt. If pt agrees, give pt information to Surgeon's Secretary or Geoff

BARIATRIC/DIABETES (B/DM) RCT
Karen Barlow 905.522.1155 x35067

Bypass vs Band vs Medical Management for treatment of T2DM

Inclusion:

· Age 18 - 65

· BMI 30 – 40 kg/m2***

· TDM for more than 6 months

· Complication related diabetes, at least one of:

- reduced quality of life

- metabolic lability / instability

- retinopathy

- nephropathy

- cardiovascular disease

*** Strata for females BMI 35 – 40 is filled

Exclusion:

· Any of the following if associated DM:

- recent myocardial infarction or cardiac revascularization(< 6 months)

- unstable angina pectoris

- clinically important abnormal ECG

- brain stroke, transient ischemic attack (TIA)

- major diabetic foot infections

- autonomic neuropathy resulting in orthostatic deregulation

- neuropathy

- clinically important cancer history

- abdominal or thoracic sx that would impact lap. bariatric procedure

- insulin dependent for > 10 years

- severe GERD with grade 3 or 4 esophagitis

- history of pulmonary embolism or DVT

- taking high dose steroids or anticoagulants

IF ELIGIBLE: Discuss study with patient. If pt agrees, give pt information to Surgeon's Secretary or Karen