[Show abstract][Hide abstract] ABSTRACT: The discTRODE probe applies radiofrequency (RF) current, heating the annulus to treat chronic discogenic low back pain. Randomized controlled studies have not been published. We assessed the long-term effect and safety aspects of percutaneous intradiscal radiofrequency thermocoagulation (PIRFT) with the discTRODE probe in a prospective parallel, randomized and gender stratified, double-blind placebo-controlled study. Twenty selected patients with chronic low back pain and a positive one-level pressure-controlled provocation discography were randomized to either intra-annular PIRFT or intra-annular sham treatment. A blinded interim analysis was performed when 20 patients had been followed for six months. The 6-month analysis did not reveal any trend towards overall effect or difference between active and sham treatment for the primary endpoint: change in pain intensity (0-10). The inclusion of patients was therefore discontinued. After 12 months the overall reduction from baseline pain had reached statistical significance, but there was no significant difference between the groups. The functional outcome measures (Oswestry Disability Index, and SF 36 subscales and the relative change in pain) appeared more promising, but did not reach statistical significance when compared with sham treatment. Two actively treated and two sham-treated patients reported increased pain levels, and in both groups a higher number was unemployed after 12 months. The study did not find evidence for a benefit of PIRFT, although it cannot rule out a moderate effect. Considering the high number, reporting increased pain in our study, we would not recommend intra-annular thermal therapy with the discTRODE probe.
[Show abstract][Hide abstract] ABSTRACT: The aim of this randomized study was to compare patient-reported outcome after laparoscopic versus open donor nephrectomy during 1 year follow-up. The evidence base has so far not allowed for a decision as to which method is superior as seen from a long-term quality of life-perspective.
The donors were randomized to laparoscopic (n=63) or open (n=59) nephrectomy, with follow-up at 1, 6, and 12 months. Primary outcomes were health status (SF-36) and overall quality of life (QOLS-N). Secondary outcomes were donor perception of the surgical scar, the donation's impact on personal finances, and whether the donor would make the same decision to donate again.
There was a significant difference in favor of laparoscopic surgery regarding the SF-36 subscale bodily pain at 1 month postoperatively (P<0.05). Analysis based on intention to treat revealed no long-term differences between groups in SF-36 scores. When subtracting the reoperated/converted donors of the laparoscopic group, significant differences in favor of laparoscopy were revealed in the subscales bodily pain at 6 months (P<0.05) and social functioning at 12 months (P<0.05). No significant differences were found in QOLS-N scores between groups.
Laparoscopic donor nephrectomy is an attractive alternative to open donor nephrectomy because of less postoperative pain. However, long-term comparison only revealed significant differences in favor of laparoscopy when adjusting for reoperations/conversions. Both groups reached baseline scores in most SF-36 subscales at 12 months and this may explain why possible minor benefits are hard to prove.
[Show abstract][Hide abstract] ABSTRACT: The aim of the present study was to compare postoperative pain and convalescence in patients randomized to laparoscopic or open donor surgery in a prospective, controlled trial. The donors were randomly assigned to undergo laparoscopic (n = 63) or open (n = 59) donor nephrectomy. Our end points were amount of administered analgesics in the recovery period, postoperative pain on the second postoperative day and at one month after surgery and duration of sick leave.
There was a significant difference in favor of the laparoscopic group regarding administered analgesics on day of surgery (p < 0. 02). No difference was observed between groups regarding self-reported pain on the second postoperative day. One month post donation, significantly fewer donors in the laparoscopic group reported pain (p < 0. 02) or had used analgesics (p < 0.05). The duration of sick leave was significantly shorter in the laparoscopic group (p = 0.01).
The laparoscopic group experienced a more rapid convalescence and a shorter period of sick leave. Although immediate postoperative pain can be managed efficiently regardless of procedure, a lower consumption of opioids and incidence of pain in the convalescent period suggest a clinically relevant patient-experienced benefit from a successful laparoscopic procedure.
Full-text · Article · Jul 2006 · American Journal of Transplantation