The goal of this clinical trial is to assess the safety and efficacy of Human Placenta Mesenchymal Stem Cells Derived Exosomes in preventing early anastomosis leak in patients undergoing low anterior resection for rectal cancer. The main question it aims to answer are
Do Mesenchymal Stem Cell-Derived Exosomes prevent early anastomosis leak in patients undergoing low anterior resection for rectal cancer?
If there is a comparison group: Researchers will compare Mesenchymal Stem Cells Derived Exosomes to placebo to see if it can prevent early anastomotic leakage.
Participants will receive intraperitoneal Mesenchymal Stem Cells Derived Exosomes at the end of their surgery.
None
Patients who need emergency surgery (presenting with peritonitis or signs of obstruction)
Patients with apparent malnutrition or patients who have serum albumin levels of less than 3 g/dl
Patients who receive corticosteroids ( an equivalent dose of prednisolone 5 mg/day or more)
Patients with chronic pulmonary disease
Parallel
Mesenchymal Stem Cells Derived Exosomes
Biological/VaccineMesenchymal Stem Cells Derived Exosomes will be administered intraperitoneally to patients at the end of their surgery
Placebo
Other intervention10 patients will receive intraperitoneal placebo at the end of their surgery
Number of patients with early anastomotic leakage
Failed surgical anastomosis after surgery measured with interview and physical examinations in follow-up sessions in clinic
Mean serum and peritoneal Interleukin-6 and Tumor necrosis factor-alpha levels in participants
The level of serum and peritoneal inflammatory markers in postoperative days measured with laboratory tests
Anastomosis integrity in Colonoscopy exam
A colonoscopy will be conducted one month after surgery to assess the integrity of the colorectal anastomosis, detect early signs of local recurrence, identify polyps, and monitor for any postoperative complications such as strictures or inflammatory changes. Baseline colonoscopies will be compared with post-surgical colonoscopy at one month. This outcome will help determine the efficacy of surgical intervention and guide future surveillance strategies in rectal cancer management.
Hospitalization length of stay
The number of days that the patient in hospitalized postoperatively
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
