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Abdominal Wall Defect clinical trials

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NCT ID: NCT04644965 Recruiting - Clinical trials for Abdominal Wall Defect

Evaluation of the Motor Activity, Cardiopulmonary Performance Capacity and Quality of Life in Patients Born With a Congenital Abdominal Wall Defect

Start date: October 5, 2020
Phase:
Study type: Observational

The two most common congenital abdominal wall defects (AWD) are gastroschisis and omphalocele. Prenatal detection is often possible and the defects are differentiated by the presence or absence of a sac around the eviscerated organs. A omphalocele occurs in 0.6-4.8 in 10,000 live births compared to 4.5 in 10,000 live births with gastroschisis. In the last years a rising incidence of gastroschisis has been shown worldwide. Both forms of AWDs necessitate early surgical intervention, mostly in one or two stages, and support at an intensive care unit in the first days of life. Additionally, patients need parenteral feeding in the first weeks of life. The outcome depends on the size of the defect and on the associated malformations. The literature about long-term outcome of these malformations is scarce. Some publications have reported long-term complications like redo-surgical procedures because of fascial gaps or umbilical or incisional hernias. Furthermore, stool irregularities, abdominal pain and several admission to the hospital due to ileus or sub-ileus have been described. Additionally, half of the patients are unsatisfied with the cosmetic result. Some other studies have shown that children born with an AWD have the same quality of life (QoL) compared with the healthy community. Nevertheless, patients with AWDs need a standardized, structured and multimodal long-time follow-up program to be able to detect any problems early and give advice to understand their illness in order to achieve the same QoL as healthy children. Therefore, the aim of this dissertation will be: - to prospectively assess the motor activity, cardiopulmonary performance capacity and QoL of patients treated with AWDs in our Department - to suggest a new standardized follow-up protocol for patients born with an AWD

NCT ID: NCT04580511 Recruiting - Clinical trials for Abdominal Wall Defect

Safety and Clinical Performance of a Biological Matrix Used in Abdominal Wall Reconstruction

PMCF_AWR
Start date: November 4, 2020
Phase:
Study type: Observational

The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS membrane used in abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure, and to identify emerging risks in comparison to the clinical data related to other types of fixation material. The present study will be a prospective multicentric non-randomized and noncontrolled trial involving 112 patients followed for 24 months. The study will be conducted in France in 3 investigational centres.

NCT ID: NCT03960320 Completed - Quality of Life Clinical Trials

Health Related Quality of Life of Patients With Abdominal Wall Defects

Start date: May 1, 2014
Phase:
Study type: Observational

Examination of the health-related quality of life of patients operated on due to congenital defects of the abdominal wall after birth with the questionnaires KINDL, SDQ and SF-36.

NCT ID: NCT03765060 Recruiting - Clinical trials for Abdominal Wall Defect

The Efficacy and Security of the Small Stitch Technique in Emergency Surgery

STCU
Start date: October 1, 2018
Phase: N/A
Study type: Interventional

This study evaluates the abdominal closure technique in emergency surgery. Half of participants will be perform the classic Large Stitch technique, while the other half will undergo the Small Stitch technique.

NCT ID: NCT03702153 Completed - Infection Clinical Trials

The Use of Synthetic Mesh in Contaminated and Infected Abdominal Wall Repairs. A Long-term Prospective Clinical Trial

Start date: January 1, 2012
Phase: N/A
Study type: Interventional

Background: Abdominal wall reconstruction in patients presenting with enteric fistulas and mesh infection is challenging. There is a consensus that synthetic mesh must be avoided in infected operations. The alternatives to using synthetic mesh, such as component separation techniques and biologic mesh, present disappointing results with expressive wound infection and hernia recurrence rates. Methods: A prospective clinical trial designed to evaluate the short and the long-term outcomes of patients submitted to elective abdominal wall repair with synthetic mesh in the dirty-infected setting, and compared to a cohort of patients submitted to clean ventral hernia repairs.

NCT ID: NCT03310905 Recruiting - Clinical trials for Transplant;Failure,Kidney

Abdominal Wall Transplant

Start date: May 1, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this protocol is to determine the safety and efficacy of abdominal wall transplantation as a treatment for the reconstruction of abdominal wall defects. Abdominal wall transplantation may be performed alone or in combination with another transplant.

NCT ID: NCT03296475 Enrolling by invitation - Ventral Hernia Clinical Trials

Intraoperative Biomechanics in Complex Abdominal Wall Reconstruction

Start date: January 9, 2018
Phase: N/A
Study type: Interventional

Background: A detailed study of the biomechanical changes before and after abdominal wall reconstruction (AWR) has not been performed. Changes in abdominal wall tension and intra-abdominal pressure have physiological consequences on respiratory and cardiology function. AWR surgeons currently do not know if they are applying too much tension when re-aligning the abdominal wall muscles during AWR. Too much tension is likely to cause respiratory and cardiac post-operative complications. The investigators propose to study the perioperative changes in abdominal biomechanics and cardiorespiratory physiology after AWR. In addition, investigators will also analyze the pre-operative patient CT scan to see if there any CT predictors of post-operative cardiorespiratory complications and hernia recurrence. The researchers hypothesize that there is a threshold value or force at which ventral hernias are repaired 'too tight' subjecting the patient to the increased risk of recurrence and cardiorespiratory complications. Method: An in depth biomechanical and physiological study of 18-22 participants with midline ventral hernias will be carried out. Ventral hernias at least 5cm in width and only those in which primary fascial closure have been achieved will be included. Any operative technique used to achieve primary fascial closure will be included. Biomechanical and physiological measurements will be taken at five separate stages during the course of the patients' abdominal wall reconstruction. The final lung function tests, taken six weeks post op, will be compared to the patients' pre-operative tests. Meticulous attention will be paid to the study protocol making sure that in each patient the measurements are all taken at the same time and under the same conditions. Discussion: This full biomechanical and physiological work up will enable AWR surgeons to assess when an AWR patient is subjected to too much biomechanical and physiological stress. The abdominal wall tension and strain will be measured to see if this predicts post complications and hernia recurrence.

NCT ID: NCT03241719 Recruiting - Clinical trials for Amputation, Traumatic

Novel Strategies to Improve Immunomodulation and Non-invasive Clinical Monitoring in VCA

Start date: October 17, 2017
Phase: Early Phase 1
Study type: Interventional

The objective of this study is to develop a feasible and safe regimen for minimization of immune suppression in recipients of vascularized composite allotransplants (VCA) using a daily dose of recombinant IL-2. In order to achieve this aim, this trial will: 1. Perform VCA in 5 eligible subjects; 2. Administer recombinant IL-2 at a low-dose to promote the expansion and function of regulatory T cells in subjects who received VCA; and 3. Minimize immune suppression to tacrolimus single therapy in subjects who received VCA and recombinant IL-2. This trial will also investigate if it is possible to predict immune rejection in VCA using blood and tissue samples from recipients of VCA. Lastly, this trial will develop non-invasive technologies to monitor for VCA rejection. These technologies will involve magnetic resonance imaging. Multi-contrast ultra-high resolution MR imaging (MRI) with serial direct planimetry will be performed in recipients of VCA.

NCT ID: NCT03035617 Recruiting - Clinical trials for Abdominal Wall Defect

Study to Evaluate Reduction in Pain After Laparoscopic Hernia Repair With Mesh Soaked in Bupivacaine Solution

HAPPIEST
Start date: November 15, 2015
Phase: N/A
Study type: Interventional

Early post-operative pain and discomfort after laparoscopic repair remains a concern for patients requiring hospital stay and parenteral narcotic analgesics . This quite often proves to be a hindrance in early ambulation, enhances patient discomfort and prevents early discharge from hospital. Local anesthetics infiltration at wound site after various procedures is known to be effective in reducing immediate post-operative pain , . In case of laparoscopic ventral hernia repair, delivering local anesthetic at site of mesh application can be achieved by soaking the mesh in local anesthetic solution before application. To date there is no evidence regarding impact of soaking mesh in bupivacaine solution before application in case of laparoscopic ventral hernia repair. OBJECTIVE: Primary Objective: To evaluate impact of impregnating mesh in .5% bupivacaine solution as compared to normal saline solution on post-operative pain after laparoscopic ventral hernia repair. Secondary Objective: To evaluate impact of impregnating mesh in .5% bupivacaine solution as compared to saline solution on length of hospital stay after laparoscopic ventral hernia repair. Study Sample: Patients with uncomplicated ventral abdominal wall hernia presenting at general surgery clinics of AKUH Karachi who are planned to undergo laparoscopic repair and meet eligibility criteria of inclusion into trial. SETTINGS: Study will be conducted in General Surgery Section of Aga Khan University Hospital, Karachi. Patients will be evaluated in clinic at the time of presentation regarding eligibility to participate in study. Written informed consent will be taken in clinic. A copy of the consent form will be handed over to the patient. Clinical Trial Unit will be informed of the scheduled date and time of the operation. Allocation will be done by the staff at clinical trial unit which will be kept undisclosed to the investigators, patients and outcome assessors. Clinical Trial Unit will provide the solution for soaking mesh in coded form according to treatment arm allocation. After the operation first assessment of pain will be done six hours post-operatively using VAS. Second assessment will be done at twenty four hours from end of operation. This assessment will be done directly if patient is admitted in the hospital or will be done on telephone if patient is discharged home. FOLLOW UP: Pain assessment will be done using visual analogue scale (VAS). This is validated score to measure level of pain. It ranges from zero to ten. Score of 0 means no pain and score of ten means worst pain one can ever have. Score will be assessed at 6 and 24 hours from procedure.

NCT ID: NCT02416674 Recruiting - Clinical trials for Abdominal Wall Defect

Vascularized Composite Allotransplantation for Treatment of Abdominal Wall Defects

Start date: March 1, 2015
Phase: Early Phase 1
Study type: Interventional

Abdominal wall transplantation surgery is the transfer of abdominal wall tissues from a deceased human donor to a patient with a large abdominal wall defect. Abdominal wall transplantation is an innovative reconstructive procedure that has the potential to significantly improve the lives of patients with large abdominal wall defects. The purpose of this study is to develop the best practices for abdominal wall transplantation that will improve the outcomes of future abdominal wall transplant recipients.