A Randomized Controlled Trial to Compare the Functional Outcome and Quality of Life of Patients with Low Rectal Cancer who Undergo a J Pouch or a Side to End Coloanal Anastomosis.
Massarat Zutshi, MD
For patients with low rectal cancer requiring an abdominal proctocolectomy (surgical removal of the rectum together with part or all of the colon.) This study will compare bowel function and quality of life after surgery, comparing 2 surgical procedures (the J pouch or side to end anastomosis) which are used to join the colon and rectum. Patient participation will last about 2 years.
A Pain Relief Trial Utilizing the Infiltration of a Multivesicular Liposome Formulation Of Bupivacaine, EXPAREL®: A Phase 4 Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal. (IMPROVE – Ileostomy Reversal)
Jon Vogel, MD
For patients scheduled to undergo surgery for ileostomy reversal. The main purpose of this study is to assess the total amount of pain medications used following surgery, and to determine if overall hospital costs can be reduced when using the study drug. The study drug will be injected into the surgical incision at the end of surgery while you are still asleep. It is thought that the timed release of medicine may provide prolonged pain control after surgery. Patient participation will end 30 days after surgery.
A Phase III Prospective Randomized Trial Comparing Laparoscopic-assisted Resection versus Open Resection for Rectal Cancer
Luca Stocchi, MD
For patients who have rectal cancer which can be removed with surgical resection, who are undergoing chemotherapy and/or radiation therapy. This study will compare safety and effectiveness of the two types of surgery currently used for rectal cancer (Open Laparotomy Resection and Laparoscopic-assisted Resection.) Patients will be randomized to one of the 2 surgery groups. There are 15 study visits (including surgery), and patients will be followed annually for 5 years after surgery.
Timing of Rectal Cancer Response to Chemoradiation
David Dietz, MD
For patients who have been diagnosed with rectal cancer that has extended through the rectal wall (Stage II) or involves the lymph nodes outside the rectum (Stage III).
The aim of this study is to determine the best time to perform surgery in relation to chemotherapy and chemoradiation (chemotherapy and radiation given at the same time). We believe that by extending the interval between chemoradiation and surgery, and by giving the chemotherapy before surgery, there may be a greater chance that the existing tumor will disappear completely by the time of surgery. Patients will participate from the day of signed consent until 30 days after surgery (about 7 months total) with annual long term data collection (such as post-op therapy and disease status) recorded for up to 5 years following surgery.
Post-market Clinical Evaluation of the Spiracur SNAP™ Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds
Michele Loor, MD
For patients with acute wounds such as post operative wounds, trauma wounds, pressure ulcers, and colostomy take-down sites. The purpose of this study is to evaluate the efficacy of the Spiracur SNaP® Wound Care System for the treatment of acute trauma and acute surgical excision wounds. This is an FDA approved device for patients who would benefit from a suction device dressing system. Comparison to patients with acute wounds previously treated will also be done, and clinical outcomes and complication rates will be evaluated. Patients will receive the SNaP® Wound Care System for up to 12 weeks, and will be in the study until the wound closes or week 12, whichever comes first.
A Randomized Controlled Trial to Compare the Efficacy of a Biological Implant, Biodesign (TM) Surgisis (R) Tissue Repair Graft, to Reinforce an Overlapping Sphincter Repair versus Standard Overlapping Sphincter Repair
Massarat Zutshi, MD
For patients who have previously been diagnosed with fecal incontinence (leakage of stool) and are scheduled to receive surgery to treat this condition. The purpose of this study is to see if placing a COOK® Biodesign™ Surgisis® Tissue Graft around the anus during surgery is more effective than repairing the anal muscle alone. Surgisis is a porcine derived piece of sterile tissue manufactured by Cook Medical Incorporated. Patients will complete a bowel diary and several questionnaires both pre and post op and will be randomized to one of two study groups (with mesh or "standard of care") before surgery. Patients assigned to the “standard care” group will receive the procedure as their doctor would normally perform the surgery. Patients assigned to the “Biodesign” group receive a piece of the Biodesign material. All other procedures and follow-up are completed as usual. Patient participation will last 24 months from the time of surgery. After discharge from the hospital, there will be 3 office visits over 2 years (standard of care visits at about 6 months, 12 months, and 24 months.) Patients may find out which group they were in upon completion of the study.
An Investigation of the Treatment of Fecal Incontinence using the TOPAS Sling System for Women. (TRANSFORM)
Massarat Zutshi, MD
This study is designed to measure the efficacy of the TOPAS Sling System , a permanent mesh that is surgically implanted with the goal of treating fecal incontinence in women. Patient participation will last approximately 39 months (9 study visits) including the completion of screening interviews, pre and post op bowel diaries, quality of life questionnaires, and follow up visits. All costs associated with the study are covered by the study sponsor. Please note that the TOPAS Sling System is not yet FDA approved for the treatment of fecal incontinence.
A Prospective Trial to Study Whether Functional Magnetic Stimulation Enhances Gastrointestinal Motility in Patients with Chronic Constipation
Massarat Zutshi, MD and Vernon Lin, MD, PhD
For patients who have been diagnosed with chronic constipation. The purpose of this study is to evaluate the effects of Functional Magnetic Stimulation (FMS) on gastrointestinal (GI) motility in patients suffering from constipation due to non-neurological issues. FMS is relatively painless and can be applied over patient’s clothing. Patients will have SmartPill testing (to evaluate GI motility), Anorectal Manometry Testing (to measure pressures and electrical activity of the anal sphincter muscles), and will fill out questionnaires. Patients will be randomized to receive either FMS for 5 weeks or sham FMS for 5 weeks (at 5% intensity to induce some sensation but no muscle movement). 20-minute stimulation will be applied 5 days a week for 5 weeks. Patients who undergo a sham will be evaluated after 5 weeks and may be offered FMS for 5 weeks. Participation in this study will about last ten weeks total (30 visits).