-
Interesting new study (RCT) evaluating the efficacy of mesh removal
It’s being handled by Dr. Krpata of the Cleveland Clinic. Basically, people with chronic pain after mesh implantation will be examined via laparoscopy and some of them will have the mesh removed, while others will not. Pain scores will be acquired afterward. If the patients who do not have the mesh removed are still feeling pain after six months they can have the mesh removed then.
If the study finds that mesh removal resolves chronic pain what will be the recommendation of Dr. Krpata – use less mesh (more pure tissue repairs), or plan for mesh removal as part of a hernia surgeon’s business model?
Maybe Dr. Krpata will be brave enough to recommend using less mesh for hernia repair, either per patient or in fewer patients, if the results show that mesh removal resolves pain. It won’t be a surprise though if the study just adds justification for more surgeries after mesh implantation. More revenue.
https://clinicaltrials.gov/ct2/show/study/NCT05484635
https://clinicaltrials.gov/ct2/show/record/NCT05484635
From the description –
“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.”
-
1 Reply
-
Is this a sign that mesh pain is being recognised at last?
It seems simple enough to evaluate and a study like this is long overdue. As is a register for the worst brands of mesh.
Log in to reply.