ABSTRACT
BACKGROUND: Transvaginal cholecystectomy (TVC) is regarded as a model operation in the newly developed field of natural orifice transluminal endoscopic surgery (NOTES). Randomized, controlled trials to assess TVC as a surgical strategy are largely missing. MATERIALS AND METHODS: The study was a double blind, randomized, controlled, single center trial in female patients > 18 years with symptomatic cholecystolithiasis comparing laparoscopic cholecystectomy (CLC) and TVC. The study investigated pain reduction of ≥ 1 point on a visual-numeric rating scale with a follow-up after 7 days. Secondary endpoints were complications and patient reported outcome. Groups were established using computer-generated randomization and sealed envelopes in the operating theatre. At the end of the surgical procedure all patients received a standard 4-trocar dressing as for CLC and a vaginal tamponade. RESULTS: A total of 426 patients were asked to participate, of which 97 were randomized, 51 in the CLC, 41 in the TVC groups and 5 were excluded from the study. Patients were comparable regarding age, body mass index (BMI) and American Society of Anesthesiologists (ASA) grade. Surgical and anesthesia times were significantly different. There was no difference in postoperative pain. The majority of patients were satisfied with both procedures and TVC was recommended to other patients by 93 % of patients in the TVC group. CONCLUSION: The results did not show superiority of TVC over CLC with regards to postoperative pain. With no differences in postoperative pain and high patient satisfaction, TVC can be recommended to future patients as an alternative method. For confirmation of this evaluation of TVC further randomized trials are needed.
Subject(s)
Cholecystectomy/methods , Natural Orifice Endoscopic Surgery/methods , Pain, Postoperative/etiology , Academic Medical Centers , Adult , Aged , Berlin , Cholecystectomy, Laparoscopic/methods , Double-Blind Method , Female , Humans , Middle Aged , Operative Time , Patient Satisfaction , Postoperative Complications/etiology , Vagina/surgeryABSTRACT
Patients with ischaemic retinopathy who show iris neovascularization despite panretinal laser photocoagulation (PRP) very often develop a neovascular glaucoma. Photodynamic therapy (PDT) has been shown to occlude neovascularization without damage to physiologic vessels or adjacent tissue in the treatment of choroidal neovascularization (CNV) and might also be of value for patients with neovascular glaucoma who did not benefit from the PRP. First results of a monocentre, open label, intra-individual controlled, pilot phase I/II, dose-finding study demonstrate that PDT with verteporfin is capable of occluding neovascular vessels for a defined period of time without damaging adjacent tissue or physiologic iris vessels. Whether this vessel occlusion will have an impact on the progression of rubeosis or neovascular glaucoma will be the subject of further investigation.
