Dataset Information

Randomized controlled trial comparing operative times between standard and robot-assisted laparoscopic hysterectomy.

ABSTRACT:

Objective

To compare the operative time between robot-assisted laparoscopic hysterectomies and standard laparoscopic hysterectomies.

Methods

A prospective, randomized controlled trial enrolled women aged 18-80 years attending Penn State Hershey Medical Center between April 23 and October 20, 2014 to undergo hysterectomy. Participants were randomized using a random number generator to undergo either robot-assisted or standard laparoscopic hysterectomy. The primary outcome was the total operative time (surgeon incision to surgeon stop, including robot docking time, if applicable). Intention-to-treat analyses were performed and the operative time was compared between the two treatments for non-inferiority, defined as a difference in operative time of no longer than 15 minutes.

Results

There were 72 patients randomized to each treatment arm. The mean operative time was 73.9 minutes (median 67.0 minutes; interquartile range 59.0-83.0 minutes) in the robot-assisted hysterectomy group and 74.9 minutes (median 65.5 minutes; interquartile range 57.0-90.5 minutes) in the standard laparoscopic hysterectomy group. The upper bound of the 95% confidence interval of the difference in operative time was 6.6 minutes, below the 15-minute measure of non-inferiority.

Conclusion

When performed by a surgeon experienced in both techniques, the operative time for robot-assisted laparoscopic hysterectomy was non-inferior to that achieved with standard laparoscopic hysterectomy. CLINICALTRIALS.GOV: NCT02118974.

SUBMITTER: Deimling TA

PROVIDER: S-EPMC5245181 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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Publications

Randomized controlled trial comparing operative times between standard and robot-assisted laparoscopic hysterectomy.

Deimling Timothy A TA Eldridge Jennifer L JL Riley Kristin A KA Kunselman Allen R AR Harkins Gerald J GJ

International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics 20161103 1

<h4>Objective</h4>To compare the operative time between robot-assisted laparoscopic hysterectomies and standard laparoscopic hysterectomies.<h4>Methods</h4>A prospective, randomized controlled trial enrolled women aged 18-80 years attending Penn State Hershey Medical Center between April 23 and October 20, 2014 to undergo hysterectomy. Participants were randomized using a random number generator to undergo either robot-assisted or standard laparoscopic hysterectomy. The primary outcome was the t ...[more]

PMID: 28099699

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Project description:IntroductionRobot-assisted laparoscopic prostatectomy (RALP) offers potential cure for localised prostate cancer but is associated with considerable toxicity. Potency and urinary continence are improved when the neurovascular bundles (NVBs) are spared during a nerve spare (NS) RALP. There is reluctance, however, to perform NS RALP when there are concerns that the cancer extends beyond the capsule of the prostate into the NVB, as NS RALP in this instance increases the risk of a positive surgical margin (PSM). The NeuroSAFE technique involves intraoperative fresh-frozen section analysis of the posterolateral aspect of the prostate margin to assess whether cancer extends beyond the capsule. There is evidence from large observational studies that functional outcomes can be improved and PSM rates reduced when the NeuroSAFE technique is used during RALP. To date, however, there has been no randomised controlled trial (RCT) to substantiate this finding. The NeuroSAFE PROOF feasibility study is designed to assess whether it is feasible to randomise men to NeuroSAFE RALP versus a control arm of 'standard of practice' RALP.MethodsNeuroSAFE PROOF feasibility study will be a multicentre, single-blinded RCT with patients randomised 1:1 to either NeuroSAFE RALP (intervention) or standard RALP (control). Treatment allocation will occur after trial entry and consent. The primary outcome will be assessed as the successful accrual of 50 men at three sites over 15 months. Secondary outcomes will be used to aid subsequent power calculations for the definitive full-scale RCT and will include rates of NS; PSM; biochemical recurrence; adjuvant treatments; and patient-reported functional outcomes on potency, continence and quality of life.Ethics and disseminationNeuroSAFE PROOF has ethical approval (Regional Ethics Committee reference 17/LO/1978). NeuroSAFE PROOF is supported by National Institute for Healthcare Research Research for Patient Benefit funding (NIHR reference PB-PG-1216-20013). Findings will be made available through peer-reviewed publications.Trial registration numberNCT03317990.

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Dataset Information

Randomized controlled trial comparing operative times between standard and robot-assisted laparoscopic hysterectomy.

Objective

Methods

Results

Conclusion

Publications

Randomized controlled trial comparing operative times between standard and robot-assisted laparoscopic hysterectomy.

Similar Datasets

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