Rectal Cancer
Conditions
Brief summary
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.
Detailed description
Anastomotic leakage remains one of the most severe complications following colorectal surgery, leading to increased morbidity, prolonged hospitalization, and reduced quality of life. Despite advances in surgical techniques and perioperative care, the incidence of early anastomotic leaks persists. Practical strategies to reduce this risk are crucial for improving patient outcomes. Recent studies have highlighted the potential role of mesenchymal stem cell-derived exosomes in enhancing tissue repair and modulating inflammation. These extracellular vesicles, derived from human placenta mesenchymal stem cells (hPMSC), contain bioactive molecules such as proteins, lipids, and RNA that facilitate cellular communication and promote healing processes. Preclinical research suggests that exosomes can support anastomotic healing by reducing local inflammation. This study aims to evaluate the safety and efficacy of intraperitoneal administration of hPMSC-derived exosomes in preventing early anastomotic leakage in patients undergoing low anterior resection (LAR) for rectal cancer. We hypothesize that the exosome treatment will significantly reduce the incidence of anastomotic leaks compared to placebo, thereby improving postoperative recovery and reducing hospital stay.
Interventions
BIOLOGICALMesenchymal Stem Cells Derived Exosomes
Mesenchymal Stem Cells Derived Exosomes will be administered intraperitoneally to patients at the end of their surgery
OTHERPlacebo
10 patients will receive intraperitoneal placebo at the end of their surgery
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
-Patients with Stage II-III rectal cancer who underwent neoadjuvant chemoradiation therapy and are candidates for low anterior resection surgery
Exclusion criteria
* 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 * Patients who need more than two units of blood transfusion perioperatively
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with early anastomotic leakage | 1 month | Failed surgical anastomosis after surgery measured with interview and physical examinations in follow-up sessions in clinic |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean serum and peritoneal Interleukin-6 and Tumor necrosis factor-alpha levels in participants | 1 month | The level of serum and peritoneal inflammatory markers in postoperative days measured with laboratory tests |
| Anastomosis integrity in Colonoscopy exam | 1 month | 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 | 1 month | The number of days that the patient in hospitalized postoperatively |
Countries
Iran
Contacts
Primary ContactSeyed Mohsen Ahmadi Tafti, MD
Outcome results
None listed