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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.
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.
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.