A randomized, controlled trial of open versus closed vaginal vault at vaginal hysterectomy

2004 ◽  
Vol 84 (1) ◽  
pp. 90-91 ◽  
Author(s):  
Janesh K. Gupta ◽  
Rinku Sengupta-Giridharan ◽  
T. Justin Clark
Keyword(s):  
Randomized Controlled Trial ◽  
Vaginal Hysterectomy ◽  
Controlled Trial ◽  
Vaginal Vault ◽  
Randomized Controlled ◽  
Open Versus

Randomized Controlled Trial Comparing Open versus Laparoscopic Placement of a Peritoneal Dialysis Catheter and Outcomes: The Capd I Trial

2017 ◽  
Vol 38 (2) ◽  
pp. 104-112 ◽  
Author(s):  
Jorinde H.H. van Laanen ◽  
Tom Cornelis ◽  
Barend M. Mees ◽  
Elisabeth J. Litjens ◽  
Magda M. van Loon ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Peritoneal Dialysis ◽  
Open Surgery ◽  
Clinical Success ◽  
Controlled Trial ◽  
Laparoscopic Group ◽  
Randomized Controlled ◽  
Surgery Group ◽  
Fixation Techniques ◽  
Open Versus

Objective To determine the best operation technique, open versus laparoscopic, for insertion of a peritoneal dialysis (PD) catheter with regard to clinical success. Clinical success was defined as an adequate function of the catheter 2 – 4 weeks after insertion. Methods All patients with end-stage renal disease who were suitable for PD and gave informed consent were randomized for either open surgery or laparoscopic surgery. A previous laparotomy was not considered an exclusion criterion. Laparoscopic placement had the advantage of pre-peritoneal tunneling, the possibility for adhesiolysis, and placement of the catheter under direct vision. Catheter fixation techniques, omentopexy, or other adjunct procedures were not performed. Other measured parameters were in-hospital morbidity and mortality and post-operative infections. Results Between 2010 and 2016, 95 patients were randomized to this study protocol. After exclusion of 5 patients for various reasons, 44 patients received an open procedure and 46 patients a laparoscopic procedure. Gender, age, body mass index (BMI), hypertension, current hemodialysis, severe heart failure, and previous an abdominal operation were not significantly different between the groups. However, in the open surgery group, fewer patients had a previous median laparotomy compared with the laparoscopic group (6 vs 16 patients; p = 0.027). There was no statistically significant difference in mean operation time (36 ± 24 vs 38 ± 15 minutes) and hospital stay (2.1 ± 2.7 vs 3.1 ± 7.3 days) between the groups. In the open surgery group 77% of the patients had an adequate functioning catheter 2 – 4 weeks after insertion compared with 70% of patients in the laparoscopic group ( p = not significant [NS]). In the open surgery group there was 1 post- operative death (2%) compared with none in the laparoscopic group ( p = NS). The morbidity in both groups was low and not significantly different. In the open surgery group, 2 patients had an exit-site infection and 1 patient had a paramedian wound infection. In the laparoscopic group, 1 patient had a transient cardiac event, 1 patient had intraabdominal bleeding requiring reoperation, and 1 patient had fluid leakage that could be managed conservatively. The survival curve demonstrated a good long-term function of PD. Conclusion This randomized controlled trial (RCT) comparing open vs laparoscopic placement of PD catheters demonstrates equal clinical success rates between the 2 techniques. Advanced laparoscopic techniques such as catheter fixation techniques and omentopexy might further improve clinical outcome.

scholarly journals Cost-effectiveness of total laparoscopic hysterectomy and non-descent vaginal hysterectomy versus total abdominal hysterectomy: a multi-centre randomized controlled trial

2019 ◽  
Author(s):  
Chanil Deshan Ekanayake ◽  
Arunasalam Pathmeswaran ◽  
Sanjeewa Kularatna ◽  
Rasika Herath ◽  
Prasantha Wijesinghe
Keyword(s):  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Vaginal Hysterectomy ◽  
Controlled Trial ◽  
Laparoscopic Hysterectomy ◽  
Total Abdominal Hysterectomy ◽  
Abdominal Hysterectomy ◽  
Total Laparoscopic Hysterectomy ◽  
Randomized Controlled ◽  
Clinical Trials Registry

Abstract Background: Hysterectomy is the most common major surgical procedure in gynaecology. The methods in mainstream practice are; total abdominal hysterectomy (TAH), non-descent vaginal hysterectomy (NDVH) and total laparoscopic hysterectomy (TLH). Most patients requiring hysterectomy for benign gynaecological conditions can be operated using one of these methods. The aim of this study was to study cost-effectiveness of NDVH, TLH and TAH in a low resource setting. Methods: A pragmatic multi-centre three arm (parallel groups) RCT was done in the professorial gynaecology unit of the North Colombo Teaching Hospital, Ragama and the gynaecology unit of the District General Hospital, Mannar, Sri Lanka. Participants were patients requiring hysterectomy for non-malignant uterine causes. Exclusion criteria were uterus>14 weeks, previous pelvic surgery, medical illnesses which contraindicate laparoscopic surgery, and those requiring incontinence surgery or pelvic floor surgery. The main outcome measures were time to recover and cost. The willingness-to-pay (WTP) threshold was set at USD 1000. Results: There was no significant difference in median time to recover (inter quartile range) among TAH, NDVH and TLH which was 35 (30-45), 32 (24.5-60) and 30 (25.5-45) days respectively (p=0.37). The difference in area under the curve for quality adjusted life years (QALYs) was 1.33 and 5.21 for NDVH and TLH compared to TAH. The direct cost (median, interquartile range) of a TLH [USD 349 (322-378)] was significantly higher compared to TAH [USD 289 (264-307)] and NDVH [USD 279 (255-305)]. The incremental cost-effectiveness ratio (ICER) for TLH was USD 12/day whereas NDVH showed a net benefit as both costs and median effect were superior to TAH. The incremental cost utility ratio (ICUR) for TLH and NDVH were 12 and 38 USD/QALY. The ICUR for TLH compared to NDVH was USD 3/per QALY. The net monetary benefit (NMB) was USD 4897 and USD 1264 for TLH and NDVH respectively. Conclusion: Despite there being only a marginal difference among the three routes when considering time to recover, a cost-effectiveness approach using ICER, ICUR and NMB shows that alternate routes, NDVH and TLH to be superior to the conventional TAH. Trial Registration: Sri Lanka clinical trials registry, SLCTR/2016/020 and the International Clinical Trials Registry Platform, U1111-1194-8422, on 26 July 2016. Available from: http://slctr.lk/trials/515. Keywords: Non-descent vaginal hysterectomy, total laparoscopic hysterectomy, total abdominal hysterectomy, cost-effectiveness, randomized controlled trial.

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