Digestive System Diseases

All Conditions

Behaviors and Mental Disorders

Fecal Incontinence

Rectal Diseases

Intestinal Diseases

Gastrointestinal Diseases

Quality of Life

Central Nervous System Depressants

All Drugs and Chemicals

Anticoagulants

Anesthetics

PRP is prepared using a special device (VS-400, Genesis Comp, Korea). For each application a kit (e+ PRP, Genesis Comp, Korea) will be used. 18 cc of venous blood will be collected from the patient into the syringe with 2 cc of anticoagulant, and will be gently inverted. The sample will be slowly injected into the e+ PRP kit. The kit will be centrifuged under 1,500G for 4 minutes, which will separate the blood components into 3 different layers. The rot at the top of the kit will be pressed until the bottom of the piston will touch the red blood cell layer, and the rot will be turned clockwise to close it. The cap will be opened and the small syringe will be connected to the cap for extracting PRP. The injection will be performed in operation room under general anesthesia with either IV sedation of laryngeal mask airway (LMA) sedation. 10 cc of PRP will be directly injected in external muscles at 8 locations under the guidance of endoanal ultrasound

PRP injection into tha anal canal in patients underwent low anterior resection for rectal cancer

Platelet Rich Plasma

Mustafa C Haksal

Mustafa C Haksal, MD

Mustafa Oncel, Prof

The treatment of fecal incontinence after low anterior resection is problematic, and not always able to increase quality of life. Biofeedback and rehabilitation therapies are harmless and easy to use; thus, generally selected as the initial treatment modalities, however may be effective in a small portion of patients. More complex treatment techniques including sacral nerve stimulation decrease the severity of symptoms, however the implantation of the device is a costly, staged procedure. Little is known about the effectiveness of other techniques such as injectable substances on incontinence observed after low anterior resection. There is no study evaluating the safety and effectiveness of platelet rich plasma (PRP) injection for incontinent patients after low anterior resection.

Rectal cancer is a common problem worldwide and the standard potentially curative treatment for locally advanced disease includes radical surgery appreciating oncological principals. Sphincter-saving procedures have been practiced in order to prevent a permanent stoma; however, patients underwent low anterior resection may suffer from several problems including incontinence particularly if the initial tumor is located too close to the anal canal. The actual frequency of incontinence is still unknown because of wide variation rates in several reports ranging between 0 to 80%; and may be a long-term problem since a series has presented an incidence of 36% 10 years after surgery.

Several mechanisms may cause incontinence after low anterior resection, thus several therapeutic instruments have been described considering the underlying reason. The most reasonable suspect is probably an injury to the sphincters at the time of surgery or secondary to preoperative radiation therapy, which is a commonly used modality in order to reduce local recurrence and increase the possibility of sphincter-saving procedures with the shrinkage of the tumor. Surgery and/or (chemo)radiation may not only generate sphincter injury, but also cause nerve damage and consequent denervation of the sphincters. Internal sphincters are responsible for resting pressure. Incontinence is more often and obvious if an intersphincteric resection with a hand-sewn coloanal anastomosis is attempted, since this procedure indicates the removal of internal sphincters. Several studies have revealed that up to 20% of patients have internal sphincter injuries after low anterior resection proven with endoanal ultrasound or manometer; and diminution in size of sphincters and decrease in resting pressure are correlated with incontinence grade. Mechanical anal sphincter injury may occur during the insertion of stapler; thus, incontinence may also be observed in patients with more proximally located tumors. The effect of radiation therapy on sphincter functions is also well-known, and a prospective randomized trial has shown that radiotherapy is significantly increasing incontinence rate. Another mechanism in incontinence may be related to the reduction of the capacity of neorectum, since descending colon, which is the reconstructing organ in most cases is narrower than rectum itself. Several reservoir techniques including coloplasty, colonic j-pouch and side-to-end anastomosis have been described in order to increase pooling volume of neorectum. Some other factors including decrease in sensitivity of anal canal and anal transitional zone, alteration in rectoanal inhibitory reflex, motility dysfunction of neorectum and incomplete evacuation may separately cause incontinence or increase the severity of symptoms. Instead of a sole origin, a combination of several reasons may be present at the same time making the problem more complex and the solution tougher. The treatment of incontinence is problematic, and not always able to increase quality of life. Biofeedback and rehabilitation therapies are harmless and easy to use; thus, generally selected as the initial treatment modalities, however may be effective in a small portion of patients. More complex treatment techniques including sacral nerve stimulation decrease the severity of symptoms, however the implantation of the device is a costly, staged procedure. Little is known about the effectiveness of other techniques such as injectable substances on incontinence observed after low anterior resection. Some patients may require fecal diversion in order to achieve a better quality of life.

Platelet Rich Plasma (PRP) is a thrombocyte enriched liquid, and it increases cell proliferation and collagen formation where it is injected. Platelets activate some growth factors, cytokines and other bioactive mediators, and consequently initiate and regulate wound-healing period. PRP has been used in several chronic diseases for initiating and fastening the reconstruction phase, particularly for the tendon, muscle, ligament and articular system related injuries and inflammatory situations. The effects of PRP on symptoms and healing rate in patients with lateral epicondylitis and its superiority over bupivacaine or steroid injections have been shown in cohort and prospective randomized trials. PRP is also tested for the treatment of perianal fistula. When PRP injection is combined with mucosal advancement flap procedure, it has been shown to decrease the recurrence rate. In an animal model, PRP injection into the gastrocnemius muscle has shown to increase the strength of the muscle healing. Although it has a potential, -to the best to our knowledge- there is no study evaluating the safety and effectiveness of PRP injection for incontinent patients after low anterior resection.

Methods:

This project is a single arm, cohort study evaluating the safety and effectiveness of PRP injection into the anal sphincter on incontinence and related quality of life in incontinent patients after low anterior resection for rectal cancer. All participating patients will be informed about the protocol and PRP application, and informed consent will be obtained. The study will be run at Department of General Surgery at Istanbul Medipol University Medical School (IMU) and be completed in 24 months. Local Ethical Committee has approved the protocol (protocol number: 66291034-29) and The Scientific and Technological Research Council of Turkey (TUBITAK) has granted the study (project number: 117s133). First patient accrual is planned to happen before August 2019. For the first year, only the patients who had their previous cancer operation at IMU will be included to the study, but in case of a shortage in number of patients by the end of August 2020, the inclusion of the patients who had their initial surgeries in other institutions will be permitted.

Local Ethical Committee and governors of TUBITAK will be free to monitor the trial progress at any time. Actual status of the study will be reported to TUBITAK for observation and for the continuity of grant imbursements annually (twice during the study period) and after the finalization of data analysis and publishing. Interim analysis will not be stated, since the design has not been classified as high risk.

The injection will be performed in operation room under general anesthesia with either IV sedation of laryngeal mask airway (LMA) sedation. In case a perfect relaxation will not be achieved, then the patient will be intubated. The patient will be positioned as gynecological position. 10 cc of PRP will be directly injected in external muscles at 8 locations under the guidance of endoanal ultrasound. The final condition of the sphincters will be pictured with the device. The same surgeon (MCH) will perform all procedures. No antibiotics will be used. Local anesthetics will not be injected. If the patient will feel pain after the operation, he/she will be free to use oral painkillers. The patient will be discharged from the hospital on the same night or the day after according to the patient's desire. Patients will be questioned for possible PRP complications during the hospitalization period, and they will be asked to report anytime during the study period.

PRP Injection Into Anal Sphincters for Fecal Incontinence

The Effect of Platelet Rich Plasma Injection Into the Anal Sphincters on Fecal Incontinence and Quality of Life in Incontinent Patients Had Treated With Low Anterior Resection for Rectal Cancer

all IPD that underlie results in a publication

This scoring system cross-tabulates frequencies and different anal incontinence presentations (Gas/Liquid/Solid/Pad use/Need for lifestyle alterations) and sums the returned score to a total of 0-20 (where 0 = perfect continence and 20 = complete incontinence). Each of the incontinence presentations is graded equally.

analyzes different incontinence situations (solid, liquid, gas) and frequencies. Lifestyle alteration, need to wear a pad, taking constipating medicaiton and Lack of ability to defer defecation for 15 minutes. Minimum score is 0 = perfect continence; maximum score is 24 = totally incontinent.

The Pescatori AI score is a grading system that combines both degree of incontinence (flatus-mucus/liquid stool/solid stool) with frequency. Incontinence ratings of A, B and C indicate AI for flatus/mucus, liquid stool, and solid stool, respectively; frequency scores of 1, 2 and 3 indicate occasional, weekly, and daily AI. A score of zero is given for normal continence. The combined score is the sum of the degree and the frequency. The minimum score is 0 and the maximum score is 6

a disease-specific tool, was designed to evaluate the impact of FI on four aspects of patients' QOL: lifestyle; coping behavior; depression or self perception; and level of embarrassment. The scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items), Coping/Behavior (9 items), Depression/Self-Perception (7 items), and Embarrassment (3 items).Each aspect is described as a score measured on a scale between 1 and 4, where 1 is very affected and 4 is not affected

The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health

Istanbul Medipol University Hospital

Wounds and Injuries

Symptoms and General Pathology

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Pain

Pilonidal Sinus

Paranasal Sinus Diseases

Cysts

Nose Diseases

Respiratory Tract Diseases

Otorhinolaryngologic Diseases

Pharmaceutical Solutions

Anti-Infective Agents

Blood Substitutes

Coagulants

Micronutrients

Povidone-Iodine

Povidone

Hemostatics

Iodine

Cadexomer iodine

The open surgical method and a moist gauze (with saline) were applied to patients in group A

Open surgery and then PRP application were performed on patients in group B. After the cavity was filled with PRP, the wound was covered with a dry gauze.

PRP was applied to the patients in group C after curettage of the sinus cavity. And again the wound was covered with a dry gauze.

Each patient entered the operating room, and after the administration of general anaesthesia, the patient was placed in the prone position. Then, the buttocks were stretched to the lateral sides using adhesive bands to remove the disease area. The sacrococcygeal region was cleaned and disinfected with 10% povidone iodine. After covering the area around the region, the sinus tract was examined by using a thin-steel cane. The length and wealth of the cavity were noted. Then, the sinus tract was removed. The depth of the cavity was noted. Then, 50 cc of 0.9% saline solution (SS) was taken into a syringe and applied to the cavity until it filled the whole space, allowing the cavity volume to be measured accurately. The measurement was performed by subtracting the remaining saline-solution volume in the syringe from the whole syringe volume, which was 50 cc.

Open surgery

In the operating room, after the patient was placed in the prone position, the region was removed by stretching the buttocks with adhesive bands and cleaning the area with 10% povidone iodine. The largest pit was excised, and hairs in the cavity were removed with forceps. Then, the whole cavity was curetted meticulously and irrigated with SS. After haemostasis, the cavity volume was measured

Minimal invasive surgery

Platelet rich plasma (PRP) was administered by filling the whole space from the lateral side of the cavity. After the first implementation of PRP, the second one was applied at 48 hours. Until that time, the dressing was not uncovered. PRP was applied on the 3rd, 4th and 5th days postoperatively.

Platelet rich plasma administration

Can Y Boztug, MD

Cihangir Akyol, MD

Pilonidal sinus disease is a common health-care problem, and surgical excision is the standard treatment modality. Controversy still exists regarding the best surgical technique for treating pilonidal disease in terms of minimizing disease recurrence and patient discomfort. In this study, the investigators compared the impact of autologous platelet-rich plasma (PRP) with that of minimally invasive techniques on pain reduction, return to daily activities, quality of life, and duration of wound healing after open excision and secondary closure.

Pilonidal sinus disease is a health problem that has been attempted to be overcome by various treatment modalities since the first time it was described by Herbert Mayo in 1833. PS is usually diagnosed at 30 years of age, and the disease has a male predominance of 70-80%.

Common morbidities after the surgical treatment of PS are pain, loss of productive work hours and wound infections owing to long healing times. Therefore, the main goals of treatment are accelerating the healing time by decreasing pain and reducing the loss of productive work hours.

Local administration of platelet-rich plasma (PRP), which contains growth factors (Gfs), is a new method that has been reported to accelerate the healing process by 30-40% \[2\].

In this study, we aimed to investigate the effect of PRP on the pain score, wound-healing process and quality of life in the treatment process for PS disease.

METHOD

Trial Design The investigators designed the trial as a prospective, controlled-randomized study. The study was started after obtaining patient consent and approval from the Ethics Committee of Ankara University Medicine Faculty in Ankara (Ethics Committee no: 03-162-18).

Randomization The patients were divided into three groups randomly. A simple randomization diagram was used for randomization. The open surgical method and a moist dressing were applied to patients in group A. Open surgery and then PRP application were performed on patients in group B. PRP was applied to the patients in group C after curettage of the sinus cavity.

Medical and Demographic History After enrolling the patients, the investigators noted all demographic data, including gender, age, education, comorbid disease existence and drug use. Then, Short Form-36 (SF-36) and Nottingham Health Profile (NHP) quality-of-life score forms were given to the patients, who were asked to complete the questionnaires before the surgery.

All patients were asked to clean the sacrococcygeal region from hair using depilatory cream.

Surgical Procedure The investigators designed group A as the control group. In this group, each patient entered the operating room, and after the administration of general anaesthesia, the patient was placed in the prone position. Then, the buttocks were stretched to the lateral sides using adhesive bands to remove the disease area. The sacrococcygeal region was cleaned and disinfected with 10% povidone iodine. After covering the area around the region, the sinus tract was examined by using a thin-steel cane. The length and wealth of the cavity were noted. Then, the sinus tract was removed. The depth of the cavity was noted. Then, 50 cc of 0.9% saline solution (SS) was taken into a syringe and applied to the cavity until it filled the whole space, allowing the cavity volume to be measured accurately. The measurement was performed by subtracting the remaining saline-solution volume in the syringe from the whole syringe volume, which was 50 cc. After measurement of the cavity volume, the cavity was dressed with wet gauze, and the operation ended.

PRP Administration Group B was designed as local PRP administration after excision. Whole steps were applied the same as in the first group until the step of dressing the cavity. After measurement of the cavity volume with 0.9% SS, PRP was administered by filling the whole space from the lateral side of the cavity. After the first implementation of PRP, the second one was applied at 48 hours. Until that time, the dressing was not uncovered. PRP was applied on the 3rd, 4th and 5th days postoperatively.

Minimal Invasive Surgery Group C was designed to receive local PRP administration after minimally invasive surgery with local anaesthesia. In the operating room, after the patient was placed in the prone position, the region was removed by stretching the buttocks with adhesive bands and cleaning the area with 10% povidone iodine. The largest pit was excised, and hairs in the cavity were removed with forceps. Then, the whole cavity was curetted meticulously and irrigated with SS. After haemostasis, the cavity volume was measured, and PRP was applied to the cavity. After the first implementation, as in the second group, we applied PRP on the 2nd, 3rd, 4th and 5th days after surgery.

Preparation of PRP For clinical applications, GMP-compliant human platelet concentrates can be created by the PRP method. Erythrocyte concentrate and platelet-containing plasma are separated by the first centrifugation, and platelet-poor plasma (PPP) and platelet-rich plasma (PRP)/platelet concentrate are created by the second centrifugation of the platelet-containing plasma \[3\]. Platelets contain coagulation factors, growth factors (PDGF, TGFβ1, IGF1, HGF1, VEGF, FGF2) and interleukins (IL1, IL4, IL6, IL10, IL13) \[4\].

The investigators prepared the platelet concentrate by the PRP method in Hacettepe University Blood Center Laboratory considering all standardized processes for healthy blood donors. In accordance with the 'National Blood and Blood Components Preparation Use and Quality Assurance Guidelines', the requirements for PRP should include at least 40 mL in volume, at least 60x109/unit platelets \[5\], and a maximum of 0.2x109/unit leukocytes \[6\]. After approval, 450 cc of blood was drawn from the patient by phlebotomy on the morning of surgery. A two-stage centrifugation method was used in the process of separating complete blood into its components. In the first stage, plasma was separated with the erythrocyte suspension by using temperature-controlled Heraeus Cryofuge 6000i low-speed centrifugation (22°C, 2500 rpm, 7 minutes). After a 1-hour waiting period at the second stage, the PRP/platelet concentrate was separated from the PPP by using high-speed centrifugation (22°C, 3200 rpm, 15 minutes). The PRP/platelet concentrate obtained after the second centrifugation step was shaken in the agitator for 1 hour, divided into 5 equal parts with a sterile connection device (Figure) and then sent to the Ankara University General Surgery Department.

The investigators preserved the PRP at 25 degrees Celsius in agitators. Before each dressing, the investigators applied the PRP aliquots to the wound by taking them one by one into the injector.

Postoperative Care All patients were discharged on the first postoperative day. Patients in all groups were advised not to open the wound for 2 days. Additionally, the surgical area had to be kept clean after bathing and bowel movements. If the patients experienced pain, they were recommended to take the prescribed pain reliever no more than 2 times a day.

The patients were divided into three groups randomly. A simple randomization diagram was used for randomization.

The open surgical method and a moist dressing were applied to patients in group A.

Open surgery and then PRP application were performed on patients in group B. PRP was applied to the patients in group C after curettage of the sinus cavity.

49 patients were included in the analysis. In this study, we compared the impact of autologous platelet-rich plasma (PRP) with that of minimally invasive techniques on pain reduction, return to daily activities, quality of life, and duration of wound healing after open excision and secondary closure.

Application of Platelet-rich Plasma in Pilonidal Sinus Disease

Application of Platelet-rich Plasma for the Management of Pilonidal Sinus Disease: A Randomized Clinical Trial of Different Treatment Modalities

Wound healing rate was evaluated as recovery time per the cavity volume (day/cc). This showed the time required for each 1 cc volume of the cavity to be filled on a daily basis. After open or minimally invasive surgery, the volume of the cavity was measured with saline solution. The cavity was filled with saline and the volume of the cavity was determined by calculating how much fluid it took. The measurements were performed on postoperative days 0, 2, 3, 4 and 21. Therefore recovery time per the cavity volume was calculated according to the differences between the measurements.

We used a visual analogue scale (VAS) to evaluate the pain score. The VAS score can range from 0 to 10. The higher the score, the higher sensation of pain. The VAS was applied five times after surgery: at 24 hours, 48 hours, 96 hours, 120 hours and 3 weeks. Patients were routinely prescribed "dexketoprofen trometamol" and recommended to take it no more than 2 times a day. How many tablets the patients used after the operation was recorded.

Short Form-36 (SF-36) and Nottingham Health Profile (NHP) questionnaires were applied to evaluate the quality of life before the surgery and three weeks after.

The SF-36 consists of eight scaled scoresand each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.

The NHP consists of two parts. The highest score in any section is 100 The higher the score, the greater the number and severity of problems We assessed the general health, limitations or activities, physical health problems, emotional health problems, social activity, pain, energy and emotions of the patients with the SF-36 questionnaire. Additionally, we evaluated the pain, energy level, emotional reaction, sleep, social isolation, and physical abilities of patients with the NHP questionnaire.

Cihangir Akyol

Associate Proffessor

Musculoskeletal Diseases

Bone Cysts

Pathological Conditions, Anatomical

Bone Diseases

Mitogens

Patients with traumatic bone cyst defect are injected with PRP

injection of PRP to traumatic bone cyst defect

PRP injection

Reza Tabrizi, DMD

Shole shahidi, DDS

Touba Karagah, DMD

Nasibeh Zare, DDS

The traumatic bone cyst (TBC) is an infrequent nonepithelial lined cavity of the jaws, which was first expressed by lucassin 1929, the lesion has attracted a great deal of interest in the dental literature, but its pathogenesis is still not evidently recognized. It determines a bone cavity of irregular shape which appears like a cyst on a radiograph, and histopathologically there are no elements to confirm a diagnosis of a cysts. TBC the international histological classification assumed by the World Health Organisation for odontogenic tumours utilizes the term "solitary bone cyst", nevertheless the term "traumatic bone cyst" (TBC) is more extensively used in the literature. The WHO classification explains TBC as a non-neoplastic osseous lesion because it demonstrates no epithelial lining, which differentiates this lesion from the true cysts. There is general conformity that most traumatic bone cysts present without symptoms or signs. Seldom, expansion of the cortical plate may occur with extraoral swelling, less commonly there may erosion through the cortical bone may take place.' Teeth in the area of involved bone usually remain vital, without root resorption or tooth mobility. Treatment of traumatic bone cysts has included surgical exploration and curettage to motivate bleeding within the bony cavity,' packing of the cyst cavity with Gelfoam which has been saturated with thrombin and penicillin, and bone grafting based on previous study Injection of autogeneic blood into the bony cavity of a traumatic bone cyst was followed by rapid resolution of the lesion.

Platelet-rich plasma (PRP) is a rich source of growth factors. The growth factors present in PRP are familiar, including transforming growth factor-_ (TGF-_1 and TGF-_2), vascular endothelial growth factor, 3 isomers of platelet-derived growth factor (PDGF-__,PDGF-__, and PDGF-__), and endothelial growth factor. These growth factors are considered to have the capacity to accelerate chemotaxis, mitogenesis, angiogenesis, and synthesis of collagen matrix and support tissue repair when applied on bone wounds. Due to this high platelet content, PRP has been used in orthopaedic surgery, oral implantology, and periodontics with the aim of making the repair process as fast and natural as possible, as it can potentially afford considerable tissue improvement in bone and soft tissue in a similar way. PRP is easily acquired, rich in cell signalling molecules, completely autogenous and can be obtained from minimal blood volumes.the purpose of the present study is to determine the efficacy of PRP in the treatment of mandibular TBC.

The study sample consisted of 12 young adult volunteers presenting with TBC of mandible. Local ethical committee approval will be obtained before the trial starts. Laboratory tests (complete blood count, glucose, creatinine, platelets, lipid profile) were performed for all patients. These tests provided an important overview of patient health and a baseline for analysis of the prognosis of PRP use. The process for obtaining PRP basically consists of collection of a 20-mL sample of blood, centrifugation of this sample for 8 min, isolation of a 1-mL aliquot of plasma collected near the erythrocyte fraction. Surgical procedure includes: surgical exploration and injection of PRP to stimulate bone regeneration within the bony cavity . Bone repair was assessed by panoramic X-rays obtained at 2, 4, and 6 months postoperatively. Bone density was measured by area histogram analysis.

Use of PRP in Treatment of Mandibular Traumatic Bone Cyst

Efficacy of Platelet-rich Plasma in Treatment of Mandibular Traumatic Bone Cyst

change in size of the defect of bone will be measured by millimeter on radiographic examination in 2,4.6 months after PRP injection and will be compared with initial size of the defect

Evaluate effect of PRP injection to fulfill the defect of bone cyst and decrease size of the lesion

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PRP Injection Into Anal Sphincters for Fecal Incontinence	NCT04063293	Fecal Incontine...	Platelet Rich P...	18 Years - 80 Years	Istanbul Medipol University Hospital
Application of Platelet-rich Plasma in Pilonidal Sinus Disease	NCT04697082	Pilonidal Sinus Pilonidal Disea... Wound Heal Quality of Life Pain	Open surgery Minimal invasiv... Platelet rich p...	18 Years -	Ankara University
Use of PRP in Treatment of Mandibular Traumatic Bone Cyst	NCT01944410	Traumatic Bone ...	PRP injection	15 Years - 65 Years	Shiraz University of Medical Sciences

Spots Global Cancer Trial Database for prp

Every month we try and update this database with for prp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for prp

Every month we try and update this database with for prp cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for prp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.