Active clinical trials for "Tissue Adhesions"

Official title: LAPAD - A prospective study on the effect of adhesiolysis during elective laparotomy or laparoscopy on per- and postoperative complication, quality of life and socioeconomic costs Background: With improved surgical technology and ageing of the population the number of reoperations in the abdomen dramatically increases. The risk for a repeat laparotomy or laparoscopy is a high as 30% in the first ten years after a laparotomy. In over 95% of reoperations adhesiolysis is required to gain access to the abdominal cavity and operation area. Adhesiolysis significantly increases the risk for inadvertent organ damage, such as enterotomies, leading to higher morbidity, mortality and socioeconomic costs. Purpose: To define the impact of adhesiolysis on per- and postoperative complications, quality of life and socioeconomic costs. Design: Prospective observational study. Primary outcomes: adhesiolysis time inadvertent enterotomy seromuscular injury miscellaneous organ damage Serious adverse events of operation (anastomotic leakage, delayed diagnosed perforation, wound infection, abdominal infection, haemorrhage, pneumonia, urinary tract infection, abscess, fistula, sepsis, death) Secondary outcomes: Hospital stay Intensive care admission Reinterventions In-hospital costs Parenteral feeding Short term readmissions (30 days) Quality of life (Gastro- intestinal tract complaints, Short Form- 36(SF-36), DASI (Duke Activity Score Index(DASI) ) Estimated enrollment: 800 start study: 1 june 2008 Inclusion completion date: 1 june 2010 Estimated study completion date: 1 february 2011

Operations in the uterus are currently possible using a hysteroscope. One serious though rare complication of such procedures is the development of intra-uterine adhesions. There currently are no methods to prevent this. The aim of this study is to evaluate the safety of using hyaluronic gel after hysteroscopic surgery.

This study will provide long-term monitoring of two patients who received gene therapy for leukocyte adherence deficiency (LAD) under the Food and Drug Administration investigational new drug study BB-IND-7949. The IND protocol has been closed. No other patients are eligible for this study. Patients previously enrolled in BB-IND-7949 (Retrovirus-Mediated Transfer of the cDNA for Human CD18 into Peripheral Blood Repopulating cells of Patients with Leukocyte Adherence Deficiency) will be followed at least yearly for an indefinite period of time to evaluate their medical status and look for treatment side effects. The follow-up visits at the NIH Clinical Center will involve the following: Interview regarding health status during the past year Blood draw of approximately 15 milliliters for 3 years, then 5 ml annually thereafter for studies related to LAD and to make sure no unexpected effects of gene therapy have occurred The blood samples collected at the follow-up visits will be frozen and stored. If a serious medical problem arises, the sample may be checked for replication competent virus. If the gene therapy is suspected to be related to a medical problem, investigation may include a review of the patient's medical records or collection of additional blood or tissues for testing. If the patient should die, the family will be asked permission to perform an autopsy, regardless of the cause of death. Tissues taken at autopsy will be tested for any long-term effects from the gene therapy.

The primary purpose of this study is to evaluate the quality of blunt dissection during abdominal and pelvic surgery involving dissection of adhesions, separation of blood vessels and neurovascular structures while preserving the integrity of these structures.

Predicting the presence of severe adhesions may also assist clinically in several ways: first, it allows allocation of more complicated surgeries to experienced surgeons; second, the surgeons can plan and prepare better for the surgery if they know in advance whether they are going to operate a complicated surgery; third, a difficult surgery may be scheduled to be performed in an experienced center, preparing cross match blood units, and alerting the general surgeon and urologist of the potential risk for surgical complications, saving time if intervention is required. This information can permit preoperative planning by a multidisciplinary team of surgeons and allow the patient to be informed of the potentially high risk of complications.

The purpose of this study is to retrospectively review and further characterize anatomic and symptomatic changes over six months immediately following treatment of symptomatic vitreomacular adhesion (VMA) with JETREA® (ocriplasmin), including incidence, time to onset and resolution of anatomy and symptoms.

The replacement of autologous blood vessels by artificial grafts is urgently needed in clinical applications. Expanded polytetrafluoroethylene (ePTFE) grafts are the most clinically used artificial blood vessels because of its chemical and mechanical stability. But, when used as arteriovenous (AV) grafts for haemodialysis, small diameter ePTFE grafts have a high failure rate of 40% in three years in vivo because of the functional lack of an intact endothelial cell layer. Here we developed a two-step modification including chemical etching and plasma activation to enhance the hydrophilicity of ePTFE. Peptide motifs (eg. cyclic RRE, RGD) known to bind integrins on the endothelial cells were immobilized on ePTFE grafts. Functional peptide immobilization significantly increased the adherence and growth of HUVEC cells on ePTFEs. Patch ePTFE implantation in the pig's descending aorta was used to evaluate the in vivo endothelialization of these modified ePTFE grafts. At 28 days implantation, newly formed endothelial layers on peptide-immobilized ePTFE grafts were demonstrated by SEM and histological analysis. These preliminary data showed the potential to grow an intact endothelial layer to improve the patency rate of the modified ePTFE grafts.

The objective of this study is to gain information concerning the acute and longer-term morphological changes within the uterus following endometrial ablation. Hysteroscopic evaluation of the uterine cavity will be used to determine if physical access and the ability to systematically assess the post-ablation uterine cavity were preserved. The presence, location and severity of intrauterine adhesions will be documented in participants who are 3, 6 and 12 months from their standard of care endometrial ablation.

This study is to evaluate the prevalence of chronic endometritis (CE) in women with severe intrauterine adhesions and compare recurrence of adhesion in women with and without CE.

Rationale: Adhesion formation is a frequent complication after abdominal surgery. Adhesion formation might be reduced by laparoscopic surgery, however sound evidence is lacking. Colorectal surgery would be a good clinical model to investigate adhesion formation between open and laparoscopic surgery because of the adhesion formation propensity of colorectal surgery. However, a randomized controlled study to provide direct evidence is unlikely because of large numbers of patients needed for such a trial and the difficulty to check for adhesion formation at second surgery. Therefore we investigate adhesion formation after laparoscopic and open colorectal surgery for malignancy at liver surgery for metastases. Objective: The aim of our study is to compare the incidence of adhesions after laparoscopic versus open surgery for colorectal malignancies during liver resection for colorectal metastases. Study design: The study is designed as a prospective observational cohort study. Study population: All consecutive, adult patients undergoing laparotomy or laparoscopy for intended liver resection or radio frequency ablation for liver metastases of a colorectal malignancy in whom inspection of the middle and lower abdomen is possible to map adhesions. Main study parameters/endpoints: Primary endpoint is incidence of adhesions to the ventral abdominal wall around the site of the original incision. Secondary endpoints are episodes of bowel obstruction between index surgery and liver surgery; total incidence of adhesions; extent of adhesions; Zühlke classification of adhesions; performance of adhesiolysis; duration of adhesiolysis; peroperative complications: enterotomy, seromuscular injury, inadvertent organ injury during adhesiolysis; postoperative complications: delayed diagnosed perforation, SAE's. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study is an observational study. The existence of adhesions will be assessed during laparotomy or laparoscopy for the treatment of liver metastases. The laparotomy is indicated for medical treatment and should not be enlarged solely for the assessment of adhesions nor will the operating time be influenced for this purpose. Adhesions and peroperative complications have to be scored by the operating surgeon during or directly after surgery. The postoperative complications have to be scored during the postoperative course by the doctors on the ward. These assessments do not interfere with the treatment of the patients.