RANDOMIZED CONTROLLED TRIAL OF LIGASURE VESSEL SEALING SYSTEM VERSUS CONVENTIONAL SUTURE LIGATURE FOR TOTAL ABDOMINAL HYSTERECTOMY

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.

Download Full-text

Palonosetron versus ondansetron for prevention of nausea and vomiting after total abdominal hysterectomy under spinal anesthesia with intrathecal morphine: a double-blind, randomized controlled trial

BMC Anesthesiology ◽

10.1186/s12871-019-0830-7 ◽

2019 ◽

Vol 19 (1) ◽

Cited By ~ 1

Author(s):

Guilherme Oliveira Campos ◽

Marcelo de Jesus Martins ◽

Gabriel Nascimento Jesus ◽

Paulo Roberto Rios de Oliveira ◽

Caio Nogueira Lessa ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Spinal Anesthesia ◽

Intrathecal Morphine ◽

Controlled Trial ◽

Total Abdominal Hysterectomy ◽

Abdominal Hysterectomy ◽

Nausea And Vomiting ◽

Double Blind ◽

Randomized Controlled

Download Full-text

Quality of life and surgical outcome after total laparoscopic hysterectomy versus total abdominal hysterectomy for benign disease: A randomized, controlled trial

Journal of Minimally Invasive Gynecology ◽

10.1016/j.jmig.2006.08.009 ◽

2007 ◽

Vol 14 (2) ◽

pp. 145-152 ◽

Cited By ~ 80

Author(s):

Kirsten B. Kluivers ◽

Jan C.M. Hendriks ◽

Ben W.J. Mol ◽

Marlies Y. Bongers ◽

Gerard L. Bremer ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Laparoscopic Hysterectomy ◽

Total Abdominal Hysterectomy ◽

Abdominal Hysterectomy ◽

Benign Disease ◽

Total Laparoscopic Hysterectomy ◽

Randomized Controlled

Download Full-text

A Randomized Controlled Trial of Auricular Transcutaneous Electrical Nerve Stimulation for Managing Posthysterectomy Pain

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2011/276769 ◽

2011 ◽

Vol 2011 ◽

pp. 1-9 ◽

Cited By ~ 5

Author(s):

Hin Cheung Tsang ◽

Chi Shan Lam ◽

Ping Wing Chu ◽

Jacqueline Yap ◽

Tak Yuen Fung ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Nerve Stimulation ◽

Transcutaneous Electrical Nerve Stimulation ◽

Controlled Trial ◽

Total Abdominal Hysterectomy ◽

Abdominal Hysterectomy ◽

Control Group ◽

Electrical Nerve Stimulation ◽

Randomized Controlled ◽

Vas Scores

Background. A patient- and assessor-blinded randomized controlled trial was conducted to examine the effectiveness of auricular transcutaneous electrical nerve stimulation (TENS) in relieving posthysterectomy pain.Method. Forty-eight women who had undergone a total abdominal hysterectomy were randomly assigned into three groups (n=16each) to receive either (i) auricular TENS to therapeutic points (the true TENS group), (ii) auricular TENS to inappropriate points (the sham TENS group), or (iii) 20 minutes of bed rest with no stimulation (the control group). The intervention was delivered about 24 hours after the operation. A visual analogue scale was used to assess pain while resting (VAS-rest) and upon huffing (VAS-huff) and coughing (VAS-cough), and the peak expiratory flow rate (PEFR) was assessed before and at 0, 15, and 30 minutes after the intervention.Result. As compared to the baseline, only the true TENS group reported a significant reduction in VAS-rest (P=.001), VAS-huff (P=.004), and VAS-cough (P=.001), while no significant reduction in any of the VAS scores was seen in the sham TENS group (allP>.05). In contrast, a small rising trend was observed in the VAS-rest and VAS-huff scores of the control group, while the VAS-cough score remained largely unchanged during the period of the study. A between-group comparison revealed that all three VAS scores of the true TENS group were significantly lower than those of the control group at 15 and 30 minutes after the intervention (allP<.02). No significant between-group difference was observed in PEFR at any point in time.Conclusion. A single session of auricular TENS applied at specific therapeutic points significantly reduced resting (VAS-rest) and movement-evoked pain (VAS-huff, VAS-cough), and the effects lasted for at least 30 minutes after the stimulation. The analgesic effects of auricular TENS appeared to be point specific and could not be attributed to the placebo effect alone. However, auricular TENS did not produce any significant improvement in the performance of PEFR.

Download Full-text