Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
David Krpata, MD
CONTACT
Lead
David Krpata
This is a double-blinded, parallel (1:1) group, randomized-controlled, superiority trial. Patients will be blinded to their treatment allocation and will understand that by entering the study, they may receive diagnostic laparoscopy only in which case their mesh will not be removed. However, they will be allowed to consider crossing over to the mesh removal group 6 months or later after surgery if they do not have adequate pain relief. Patients will receive written and oral descriptions of the trial and will be provided time to review written documentation in private. Written and oral consent will be obtained, and patients will understand that their participation is voluntary and refusal to participate will not affect future medical care. Patients may also withdraw from the trial at any point throughout the study period. The Cleveland Clinic Center for Abdominal Core Health, a center within the Digestive Disease and Surgery Institute (DDSI), at Cleveland Clinic Foundation Main Campus in Cleveland, Ohio is the hosting department for this study. Cleveland Clinic - Hillcrest Hospital in Mayfield Heights, Ohio will also be a participating center in this study. Fellowship-trained surgeons with expertise in complex abdominal wall reconstruction and mesh removal will perform the operations. If enrollment fails to meet necessary accrual size within the study timeframe, additional centers may be invited to participate.
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
