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Professional Research


Welcome to the Clinical Research Department

For over 45 years, our surgeons have been actively engaged in clinical research. Colon and Rectal Surgery Associates investigators are dedicated to conducting quality studies that may provide a benefit to our patients or advance the science of clinical practice.

Our Areas of Focus Include:

  • Colon and rectal cancer diagnosis, staging, surgical treatment and surveillance
  • Diagnosis and treatment of complex pelvic floor disorders/dysfunction
  • Treatment of fecal incontinence/constipation
  • Laparoscopic, hand assisted, and laparotonic colon surgery
  • Minimally invasive anorectal and colorectal procedures
  • Prevention of postoperative complications e.g. ileus, wound infections, peristomal hernias, etc.
  • Surgical techniques for wound closure and support
  • Surgical interventions for inflammatory bowel disease
  • Intra-operative and post-operative pain management

A Proven Track Record

Colon and Rectal Surgery Associates has a proven track record of dependable enrollment and retention of study subjects.  We consistently rank in the top 5 enrolling sites for our industry sponsored studies and are frequently complimented by site monitors on the concise, quality data we produce. Study subject retention averages 90% at 3 years and 80% at 5 years.  Our investigators are frequently asked to serve as the Lead Investigator for multi-site studies. 
 

Industry Sponsored Studies

We participate in Phase II –IV pharma and device studies.  In recent years our industry sponsored studies have included:

  • Opioid blocking agents for postop ileus prevention
  • Treatment of  fecal incontinence
  • Injectable bulking agents
  • Use of sacral nerve stimulation
  • Mesh sling support
  • Dietary supplementation
  • Anastomotic site buttressing systems
  • Stapling devices
  • Ostomy site support systems for prevention of peristomal hernias
  • Artificial bowel sphincter replacement
  • Postoperative pain management
  • Prevention of surgical wound infection

Physician-Initiated and Outcome Focused Studies

As part of our research program, the practice partners are encouraged to develop physician-initiated and outcome-focused studies.  Recently, these areas of study have included:

  • Rectal Cancer
  • Histologic predictors of node positivity and depth of tumor invasion
  • Outcomes and continence status following local excision for rectal cancer
  • Long-term outcomes in primary and recurrent advanced rectal cancer
  • MRI vs. ERUS (endorectal ultrasound) in the pre-treatment staging of rectal cancer
  • Review of anal fistulae repair outcomes and quality of life
  • Incidence of cancer rates in patients with FAP (familial adenomatous polyposis)
  • Incidence of anastomic leak following large bowel resection
  • Comparative outcomes in sphincter injury repair

Our Staff

CRSAL’s dedication to research includes a dedicated research department staffed by a full-time manager, and full-time clinical research coordinators.  All research staff members are well-versed in the federal codes and good clinical practice standards regarding the conduct of clinical research.  They are detail oriented and experienced in all aspects of study management and regulatory processes. 

Dr. Anders Mellgren, MD, PhD has served as the Medical Director of Research since 2003. Dr. Mellgren completed his colon and rectal surgery fellowship at the University of Minnesota in 1999.  He also holds a PhD in clinical research from the University of Minnesota. He is a widely published author and speaker on topics related to diseases and disorders of the colon, rectum and pelvic floor.  Dr. Mellgren is also the Medical Director of this practice’s specialty clinic for pelvic floor disorders. Additionally, he serves as the course director for the Principles in Colon and Rectal Surgery Conference held annually in Minneapolis.

Research at CRSAL

Research at Colon and Rectal Surgery is supported by our practice partners who participate as Principal and Sub-Investigators for our studies.  We are able to perform both outpatient and inpatient clinical research.  Depending on the nature of the study, we are able to use either a central or local IRB.

Our Research Facilities Include:

  • Designated research area with staff offices
  • Exam rooms for conducting study activities
  • Office equipment including phone, fax, copy machine, and internet service for easy access to our patients and sponsors
  • Work space for on-site monitoring visits
  • Secure, locked storage for study records, equipment and supplies
  • Specialty Pelvic Floor Center clinic
  • A Medicare certified free standing endoscopy center
  • 8 clinic locations throughout the Twin Cities area
  • Affiliation with 18 hospitals and surgi-centers throughout the metro area
  • Electronic Medical Record system
  • Access to lab and phlebotomy services
  • Access to calibrated refrigeration and freezer

On-Site Services Include:

  • Colonoscopy
  • Flexible sigmoidoscopy
  • Biofeedback
  • Anorectal manometry
  • Anal, rectal, and vaginal ultrasound
  • Defecography
  • Urodynamics
  • Pudendal Nerve Terminal Motor Latency testing (PNTML)
  • EMG recruitment
  • Study subject recruitment, prescreening, treatment and followup

If you are a sponsor looking for potential sites for your study, please feel free to contact us at (651) 225-7830. 

Information for Patients about Research