Colon and Rectal Surgery

Below are current clinical trials.

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1. Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients with Locally Advanced Rectal Cancer Undergoing Surgery

   Rochester, Minn., Scottsdale/Phoenix, Ariz.

   The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good and bad, of the standard treatment of chemotherapy and radiation to chemotherapy using a combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU), oxaliplatin and leucovorin) and selective use of the standard treatment, depending on response to the FOLFOX. The drugs in the FOLFOX regimen are all FDA (Food and Drug Administration) approved and have been used routinely to treat patients with advanced colorectal cancer.

2. A Study of the Quality of Life after Surgery for Recurrent Rectal Cancer

   Rochester, Minn.

   The purpose of this study is to measure the quality and quantity of the lifespan in patients who have locally recurrent rectal cancer. It will compare survival rates and quality of life of those who have surgery to those who do not have surgery. It also aims to compare certain other factors, such as whether clear resection margins (i.e. “R0 margins” which are when no evidence of the tumour is found in the biopsy) were achieved and the influence of chemotherapy and radiotherapy.

3. Stem Cell Coated Fistula Plug in Patients With Crohn's RVF

   Rochester, Minn.

   The purpose of this study is to determine the safety of using an autologous mesenchymal stromal cell (MSC) coated fistula plug in people with rectovaginal fistulizing Crohn's disease. Autologous means that these cells that coat the plug come from you. You will be in this study for two years. There is potential to continue to monitor your progress with lifelong regular visits as part of your standard of care. All study visits take place at Mayo Clinic and Rochester, MN. The study visit schedule is as follows: Visit 1 (Week -6) - Screening visit: exam under anesthesia and surgery to assess eligibility of fistula tract, take fat biopsy, if eligible, and fecal diversion. Visit 2 (Week 0; Day 0), exam under anesthesia for stem cell coated fistula plug placement Visit 3 (Week 0; Day 1) Visit 4 (Week 2; Month 1) Visit 5 (Week 4; Month 1) Visit 6 (Week 8; Month 2) Visit 7 (Week 12; Month 3) Visit 8 (Week 24; Month 6) Visit 9 (Week 52; Month 12). Visit 10 (Week 104, Month 24)

4. Hyperbaric Oxygen for Ulcerative Colitis

   Rochester, Minn.

   The investigators aim to prospectively study the feasibility and clinical impact of hyperbaric oxygen therapy in acute hospitalized moderate to severe ulcerative colitis flares as an adjunct to standard medical treatment. Specifically, we will investigate the impact of hyperbaric oxygen therapy on clinical response/remission and serum and mucosal inflammatory markers. The investigators expect that hyperbaric oxygen therapy will improve patient responsiveness to steroids and avoid progression to second line therapy during hospitalization.

5. A Study to Assess Outcomes of Patients Undergoing Treatment of Fistula-in-ano Utilizing a Radially Emitting Diode Laser Fiber

   Rochester, Minn.

   The purpose of this study is to assess short and long term outcomes of patients undergoing treatment of fistula in ano utilizing a radially emitting diode laser fiber.