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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
20
Mesenchymal Stem Cells Derived Exosomes will be administered intraperitoneally to patients at the end of their surgery
10 patients will receive intraperitoneal placebo at the end of their surgery
Division of Colorectal Surgery, Department of Surgery, Tehran University of Medical Sciences, Tehran, Iran
Tehran, Iran
Number of patients with early anastomotic leakage
Failed surgical anastomosis after surgery measured with interview and physical examinations in follow-up sessions in clinic
Time frame: 1 month
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
Time frame: 1 month
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.
Time frame: 1 month
Hospitalization length of stay
The number of days that the patient in hospitalized postoperatively
Time frame: 1 month
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