Colorectal Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 65 years old at the time of screening, or people aged 66 to 70 years old who have no more than one heart, metabolic, or lung condition for which they are currently prescribed medication.
• People who have been diagnosed with cancer of the rectum or the lower part of the large bowel (rectosigmoid).
• People who are scheduled for planned surgery to remove part of the bowel (either open, keyhole, or robotic surgery) that will involve joining two ends of the bowel together and creating a temporary stoma (bag), with the join located no more than 15 cm from the opening of the back passage.
• People who have been fully informed about the study, agree to take part, and have signed a consent form approved by an ethics committee.
• People who are willing and able to attend all required follow-up appointments after the procedure.

Who may not be able to join:

• People whose life expectancy is less than one year.
• People whose overall health and fitness for surgery is rated at a high-risk level (ASA classification above 3 — confirm with trial site).
• People with low levels of albumin (a protein in the blood) below 30 g/litre, which can indicate poor nutrition.
• People who have an active infection anywhere in the body at the time of the procedure.
• People who have had major surgery or a major medical procedure within 30 days before joining the study, or who have another major procedure planned within one month of joining.
• People who have received chemotherapy or radiation therapy to the pelvic area within 30 days before the planned surgery.
• People who have been diagnosed with a blocked, perforated, or severely damaged bowel, or conditions such as peritonitis, ischemic bowel, cancer spread throughout the abdomen (carcinomatosis), diverticulitis, or widespread inflammatory bowel disease.
• People who have an abnormality or bowel damage near the area where the study device would be placed that could affect how safely the device works.
• People who have a blood clotting disorder, low platelet count, or a weakened immune system.
• People with a Body Mass Index (BMI) of 40 or above.
• People who are also having another major surgical procedure at the same time (such as liver surgery).
• People who have been regularly taking steroid medications in the three months before joining the study.
• People who are taking certain medications that affect the immune system (antimetabolites) or blood-thinning medicines other than aspirin.
• People who have previously had bowel surgery that involved joining sections of bowel together in the pelvic area.
• People whose bowel join would need to be smaller than 31 mm in diameter.
• People whose bowel was not adequately cleaned out before the procedure.
• People in whom a leak at the bowel join is detected during testing carried out during surgery.
• People with a known allergy to any part of the study device.
• People with a known allergy to iodine or iodine-based contrast material, unless they can be safely pre-treated to manage the allergy before the leak test.
• People with ongoing alcohol misuse or illegal drug use.
• People who have any other condition that, in the opinion of the study doctor, could put them at risk or affect the quality of the study results.
• People who are pregnant or planning to become pregnant; women who could become pregnant must have a negative pregnancy test within 7 days before the surgery.
• People who are unable or unwilling to sign a consent form.
• People who are currently taking part in another clinical trial for a drug or medical device that could interfere with this study's results.

Important: Always verify eligibility with the trial site directly before applying.