This trial studies the feasibility of placing a mesh to reinforce the closure of the abdominal wall and prevent hernia formation in left sided colon or rectal cancer patients with an ileostomy. Hernias are a common occurrence and may put unnecessary burden on patients. Reinforcement of an ileostomy closure with mesh may help to prevent the occurrence of hernia formation.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03750461.
PRIMARY OBJECTIVE:
I. To validate the technical procedure of mesh implantation at the time of ileostomy closure and preliminarily determine the incidence of surgical site occurrences (particularly those requiring intervention) compared to standard ileostomy closure technique.
SECONDARY OBJECTIVES:
I. Measure and compare quality of life scores for aspects related to the procedure to those related to bowel function.
II. To evaluate the process for longitudinally monitoring for the occurrence of hernia at site of stoma closure.
OUTLINE:
During standard of care closure of the ileostomy, a mesh is placed to reinforce the closure of the abdominal wall.
After completion of study, patients are followed up at 30 days and 6 months, and then periodically for 5 years after cancer treatment has concluded.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationDartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Principal InvestigatorMatthew Mcewen Wilson
