This trial is evaluating whether RP-L201 will improve 3 primary outcomes and 6 secondary outcomes in patients with Tissue Adhesions. Measurement will happen over the course of 2 years.
This trial requires 9 total participants across 2 different treatment groups
This trial involves 2 different treatments. RP-L201 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.
About 15% of US adults have at least one peritoneal adhesion at the time of their procedure. The incidence of these surgically repairable adhesions does not fluctuate over the course of the year.
Adhesion formation may be due to the response of mesothelial cells to surgical manipulation and may be independent of inflammation. The significance of these observations in the development of adhesions has not been fully established.
Tissue adhesions, although initially smooth, can develop into adhesive masses and lead to pain in the muscles that connect tissues with other tissues. They may form at a site of surgery (e.g. periperitoneal, abdominal, pelvic, pleural, and pericardial surfaces), or they can be of the general kind (between tissue planes), which tend to be deeper than the outer surfaces of the tissues involved. As the tissues are adhaerensed, they lose the ability to glide easily across one another. Tissue adhesions may also occur as a result of infection or injury; they can adhere tissues and form new scar tissue.
[Colicocleisis] and [subcutaneous mesh repair] are safe and effective for treating non-specific peritoneal adhesions in children. The authors state: "Further work is required to demonstrate the extent of long-term benefits of peritoneal sclerosis to other abdominal surgery.
At the time of cholecystectomy, it is most likely to occur early in the procedure. Early postoperatively, during the closure of the incision the tissue of the wound collapses and adheres to the surrounding organ and other adjacent structures. Although most adhesions occur during the operation themselves, there are several risk factors which contribute to the formation of adhesions: excessive bleeding, prior adhesions elsewhere, and manipulation at a number of times.
In general, most treatments do not affect the incidence of long-term complications. However, some techniques, especially those using microthermal bipolar RF technology with a low heat rate, may potentially help control the formation of adhesions.
The rp-l201 formulation is effective in improving the quality of life of those with persistent tissue adhesions and, in this way, might prove to be both a safe and well tolerated therapy.
The cause of tissue adhesions is not clear; it is likely that multiple variables interact to produce these phenomena. There are multiple treatment modalities to address the different causes. The pathophysiology needs to be understood prior to developing a treatment algorithm.
Recent findings indicated that the administration of rp-l201 was better than placebo in decreasing adhesion formation after abdominal hysterectomy plus salpingectomy. It was concluded that adjunctive use of rp-l201 is more effective than a placebo in reducing the number of adhesion sites and postoperative pain in patients who undergo non-opioid-related surgery with adhesion formation.
Current surgical approaches have not yet shown effectiveness in adhesion prevention. In contrast, more research is needed to determine the effectiveness of novel therapy options of tissue adhesions.
As per our experience, application of rp-l201 has not been helpful in the treatment of uterine fibroid. Because we do not understand the mechanism, we are going to explore the mechanism of action so that we know the therapeutic potential of rp-l 201.
In a recent study, findings indicate that most frequently Rp-l(alpha) is associated with chemotherapy. In a recent study, findings show the clinical usefulness of Rp-l(alpha) in combination with chemotherapy for patients with advanced breast cancer.