Power Morcellators a Review of Current Practice and Assessment of Risk

Transmission dalam beg berbanding morcellation menggunakan daya yang tidak terkawal untuk myomektomi laparoskopi

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References

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NCT02777203. Power morcellation systems for laparoscopic hysterectomy and myomectomy [Condom and efficacy of contained electromechanical power morcellation systems for laparoscopic hysterectomy and myomectomy]. clinicaltrials.gov/ct2/show/NCT02777203 (first posted 19 May 2016). CENTRAL

NCT03281460. Efficacy of In-bag morcellation (FIBROSAC). clinicaltrials.gov/ct2/show/NCT03281460 (first posted thirteen September 2017). CENTRAL

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Frascà 2018

Written report characteristics
Methods	Unblinded unmarried‐centre randomised controlled trial, conducted at the Gynecology and Homo Reproduction Physiopathology of Sant'Orsola‐Malpighi University Hospital of Bologna, Bologna, Italy
Participants	Premenopausal women aged betwixt 18 and 50 years, with an ultrasonographic diagnosis of at to the lowest degree one myoma measuring betwixt four cm and 10 cm in mean diameter, and presenting a heavy menstrual flow or infertility as indications to laparoscopic myomectomy.
Interventions	Sample size: 72 women (34 in the intervention group and 38 in the command group) In the command group, intra‐abdominal uncontained power morcellation was performed with the reusable power morcellator Rotocut G1, Storz. In the intervention grouping (extracorporeal in‐handbag manual morcellation), each enucleated myoma was placed within a specimen retrieval bag (Endo Catch 2 Motorcar Suture x‐mm or fifteen‐mm, Covidien). The edges around the purse's opening were then pulled out through the lower central x‐mm trocar incision, previously enlarged to 20 mm, forth with the abdominal fascia. The coarse was tightly grasped with Schroeder tenaculum and manual morcellation was performed with scalpel or scissors, while the first assistant carefully pulled on the edges of the bag to motion it abroad from the blade, avoiding bag damage. At the end of morcellation, the endoscopic bag was retrieved on the edges of the purse to move it abroad from the blade, fugitive bag damage, retrieved through the port incision, and filled with water to identify eventual bag disruptions.
Outcomes	The primary event was the comparison of morcellation operative times.
Notes	Dates: November 2015 to October 2016 Disharmonize of interest: none Funding source: not reported Clinical Trial Registration: not registered.
Chance of bias
Bias	Authors' judgement	Support for sentence
Random sequence generation (selection bias)	Low risk	Reckoner‐generated
Allocation concealment (selection bias)	Unclear risk	Non described
Blinding of participants and personnel (performance bias) All outcomes	High risk	Unblinded intervention
Blinding of outcome assessment (detection bias) All outcomes	High risk	Unblinded intervention
Incomplete outcome data (attrition bias) All outcomes	Depression gamble	No loss to follow‐upwards
Selective reporting (reporting bias)	Unclear risk	The study was non registered on ClinicalTrials.gov or on any other trial registry, and original protocol was not available
Other bias	Unclear risk	Insufficient reporting to make up one's mind presence of other forms of bias

Venturella 2016

Study characteristics
Methods	Unblinded single‐center randomised controlled trial, conducted at the Department of Obstetrics and Gynecology, University ''Magna Graecia'' of Catanzaro, Catanzaro, Italy
Participants	Sample size: 104 women (53 in the intervention group and 51 in the control group) Premenopausal women with heavy menstrual bleeding or women already diagnosed with fibroids from referral sources and undergoing a laparoscopic myomectomy. Inclusion criteria were the following: age between eighteen and xl years, torso mass alphabetize (BMI) xviii kg/one thousand² to xl kg/m², heavy menstrual bleeding, and the presence of at least one myoma measuring 4 cm or more in diameter (simply no myoma measuring >ten cm, according to local practice on eligibility for laparoscopy).
Interventions	In the intervention group (extracorporeal in‐bag transmission morcellation), each enucleated myoma was placed inside a rip‐stop nylon specimen purse (Endo Catch Gold Auto Suture 10‐mm or 15‐mm, Covidien), which could hold 220 mL or 1000 mL according to the size chosen. The central lower 10‐mm trocar incision was increased to xxx mm, and a 65‐mm reusable sterile pessary was placed inside the bag, between the myoma and pelvic wall, to create a barrier between the morcellated portion of the myoma and the bag. In this way, the pessary protected the purse from the coring rotational movements of either the pocketknife or the scissors and immune a more manageable coring. After exteriorisation of the fibroid's surface with the help of Alexis retractors, information technology was grasped with Schroeder tenaculum, double tooth, or Backhaus towel forceps and subjected to gradual morcellation with scalpel or pair of scissors by cautious C‐coring. Fibroid adequate traction was allowed by using different instruments, depending on the myoma consistency. In the control grouping, intracorporeal un‐independent morcellation using a power morcellator (Rotocut G1, Storz) was performed.
Outcomes	The chief outcome was the comparison of morcellation operative times.
Notes	Dates: March 2014 to January 2015 Conflict of interest: none Funding source: Department of Obstetrics and Gynecology, Academy ''Magna Graecia'' of Catanzaro Clinical Trial Registration: NCT02086435
Risk of bias
Bias	Authors' sentence	Support for judgement
Random sequence generation (selection bias)	Depression take a chance	Calculator‐generated
Allocation concealment (selection bias)	Low risk	sealed, opaque envelopes
Blinding of participants and personnel (operation bias) All outcomes	High risk	Unblinded intervention
Blinding of outcome assessment (detection bias) All outcomes	High hazard	Unblinded intervention
Incomplete issue information (attrition bias) All outcomes	Low risk	No loss to follow‐up
Selective reporting (reporting bias)	Low take chances	No deviation from the original protocol
Other bias	Unclear chance	Insufficient reporting to make up one's mind presence of other forms of bias

NCT02777203

Study proper noun	Power morcellation systems for laparoscopic hysterectomy and myomectomy
Methods	Open‐label, single center randomised trial conducted in Illinois, The states
Participants	Premenopausal women undergoing robotic or laparoscopic total or supracervical hysterectomies or myomectomies for the indication of symptomatic uterine fibroids
Interventions	In‐pocketbook morcellation with specimen morcellated in the EcoSac400 ECO‐T bag
Outcomes	Primary effect: egg albumin leakage
Starting engagement	May 2016 to July 2019
Contact information	Charles Miller, Abet Health Care
Notes	On ClinicalTrials.gov, the trial is reported as completed. It is not clear if the intervention group was manual in‐pocketbook morcellation, or in‐bag morcellation with device. We could not contact the primary investigator in order to obtain more information on this trial.

NCT03281460

Study proper noun	Efficacy of in‐bag morcellation (FIBROSAC)
Methods	Open up‐label, single centre randomised trial conducted in Bron, French republic
Participants	Women aged 18 years or more undergoing laparoscopic myomectomy or laparoscopic subtotal hysterectomy
Interventions	In‐bag morcellation with More‐cell‐Safe (AMI handbag morcellation)
Outcomes	Primary outcome: polish muscular cells in the peritoneal fluid after morcellation (after morcellation, there volition be cytology and immunohistochemistry of peritoneal washing with 500 cc of saline serum)
Starting appointment	September 2017 to February 2019
Contact data	Gautier Chene, MD. Gynaecology Section, Hôpital Femme Mère Enfant, HCL
Notes	On ClinicalTrials.gov, the trial is reported as completed. It is not clear if the intervention group was transmission in‐bag morcellation, or in‐handbag morcellation with device. We could not contact the chief investigator in order to obtain more information on this trial.

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Comparison one.Any type of in‐bag morcellation versus uncontained power morcellation

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Result size
one.1 Composite intraoperative complications Show forest plot	ii	176	Risk Ratio (M‐H, Random, 95% CI)	Not estimable
Open in figure viewer Analysis 1.1 Comparison 1: Any type of in‐bag morcellation versus uncontained power morcellation, Outcome 1: Composite intraoperative complications
i.ii Total operative time Show forest plot	2	176	Hateful Difference (IV, Random, 95% CI)	ix.93 [‐1.35, 21.20]
Open in effigy viewer Analysis 1.ii Comparing 1: Any type of in‐pocketbook morcellation versus uncontained ability morcellation, Outcome 2: Total operative time
1.3 Morcellation operative time Show forest plot	2	176	Mean Divergence (Iv, Random, 95% CI)	2.59 [0.45, 4.72]
Open in figure viewer Assay 1.3 Comparison one: Whatever type of in‐bag morcellation versus uncontained power morcellation, Consequence 3: Morcellation operative time
1.4 Ease of morcellation Show wood plot	i		Hateful Deviation (Iv, Random, 95% CI)	Subtotals only
Open in effigy viewer Assay 1.iv Comparing one: Any blazon of in‐bag morcellation versus uncontained power morcellation, Upshot 4: Ease of morcellation
1.5 Postoperative length of stay Bear witness forest plot	2	176	Hateful Difference (IV, Random, 95% CI)	0.03 [‐0.42, 0.49]
Open up in figure viewer Assay 1.5 Comparing 1: Whatever type of in‐bag morcellation versus uncontained power morcellation, Outcome five: Postoperative length of stay
1.6 Postoperative pain Show woods plot	2	176	Mean Difference (IV, Random, 95% CI)	0.22 [‐0.l, 0.94]
Open in figure viewer Analysis one.6 Comparison one: Any type of in‐bag morcellation versus uncontained power morcellation, Result 6: Postoperative hurting
1.7 Conversion to laparotomy Show woods plot	2	176	Hazard Ratio (Thousand‐H, Random, 95% CI)	Not estimable
Open in figure viewer Analysis 1.7 Comparison 1: Any type of in‐pocketbook morcellation versus uncontained power morcellation, Event 7: Conversion to laparotomy
i.viii Postoperative diagnosis of leiomyosarcoma Show forest plot	2	176	Risk Ratio (Thou‐H, Random, 95% CI)	Not estimable
Open in figure viewer Analysis 1.8 Comparison 1: Any type of in‐bag morcellation versus uncontained power morcellation, Outcome viii: Postoperative diagnosis of leiomyosarcoma
1.9 Postoperative complications Show forest plot	2	176	Risk Ratio (M‐H, Random, 95% CI)	0.lxxx [0.xvi, 4.12]
Open in figure viewer Assay 1.nine Comparing 1: Any type of in‐bag morcellation versus uncontained power morcellation, Issue nine: Postoperative complications

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Comparing 2.Sensitivity analysis: fixed‐effect model

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.i Total operative fourth dimension Evidence forest plot	ii	176	Mean Difference (IV, Fixed, 95% CI)	9.52 [0.53, xviii.51]
Open up in figure viewer Analysis 2.ane Comparing 2: Sensitivity assay: fixed‐consequence model, Outcome 1: Full operative time
2.2 Morcellation operative time Show woods plot	ii	176	Mean Departure (Iv, Fixed, 95% CI)	2.59 [0.45, 4.72]
Open in figure viewer Assay 2.ii Comparison ii: Sensitivity analysis: fixed‐effect model, Upshot 2: Morcellation operative time
two.3 Postoperative length of stay Testify wood plot	2	176	Mean Difference (IV, Fixed, 95% CI)	‐0.05 [‐0.25, 0.15]
Open up in figure viewer Analysis two.iii Comparing ii: Sensitivity assay: fixed‐result model, Event 3: Postoperative length of stay
2.iv Postoperative hurting Show forest plot	2	176	Mean Difference (IV, Fixed, 95% CI)	0.05 [‐0.27, 0.37]
Open in effigy viewer Analysis 2.4 Comparison 2: Sensitivity analysis: stock-still‐consequence model, Event 4: Postoperative pain
2.5 Postoperative complications Show forest plot	2	176	Hazard Ratio (M‐H, Fixed, 95% CI)	0.76 [0.16, 3.68]
Open in effigy viewer Assay 2.5 Comparing 2: Sensitivity analysis: stock-still‐outcome model, Issue 5: Postoperative complications

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Effigy 1

Written report flow diagram

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Effigy two

'Risk of bias' graph: review authors' judgements nearly each risk of bias item presented every bit percentages across all included studies

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Effigy 3

'Risk of bias' summary: review authors' judgements about each 'Risk of bias' item for each included study

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Effigy 4

Forest plot of comparison: ane Any type of in‐bag morcellation versus uncontained power morcellation, outcome: 1.1 Composite intraoperative complications

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Figure 5

Woods plot of comparison: 1 Whatever type of in‐handbag morcellation versus uncontained power morcellation, event: 1.2 Total operative fourth dimension

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Effigy 6

Wood plot of comparison: 1 Any type of in‐bag morcellation versus uncontained power morcellation, upshot: i.iii Morcellation operative fourth dimension

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Analysis ane.1

Comparing i: Any type of in‐bag morcellation versus uncontained power morcellation, Outcome 1: Composite intraoperative complications

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Assay one.2

Comparison 1: Any type of in‐bag morcellation versus uncontained power morcellation, Outcome 2: Full operative fourth dimension

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Analysis one.three

Comparison 1: Any type of in‐bag morcellation versus uncontained power morcellation, Outcome three: Morcellation operative time

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Assay 1.four

Comparison i: Whatever type of in‐pocketbook morcellation versus uncontained power morcellation, Issue 4: Ease of morcellation

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Assay one.5

Comparison 1: Any type of in‐bag morcellation versus uncontained power morcellation, Outcome 5: Postoperative length of stay

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Analysis 1.six

Comparison 1: Any type of in‐bag morcellation versus uncontained power morcellation, Outcome 6: Postoperative pain

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Analysis 1.vii

Comparison 1: Any type of in‐bag morcellation versus uncontained ability morcellation, Issue seven: Conversion to laparotomy

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Analysis 1.viii

Comparison 1: Any blazon of in‐bag morcellation versus uncontained power morcellation, Consequence 8: Postoperative diagnosis of leiomyosarcoma

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Analysis 1.ix

Comparison 1: Any type of in‐bag morcellation versus uncontained power morcellation, Consequence 9: Postoperative complications

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Analysis 2.1

Comparison two: Sensitivity analysis: fixed‐upshot model, Upshot one: Total operative fourth dimension

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Analysis 2.2

Comparison 2: Sensitivity assay: fixed‐effect model, Outcome two: Morcellation operative fourth dimension

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Analysis 2.iii

Comparison 2: Sensitivity analysis: fixed‐upshot model, Outcome 3: Postoperative length of stay

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Assay 2.iv

Comparison two: Sensitivity analysis: fixed‐effect model, Upshot four: Postoperative pain

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Assay ii.5

Comparison 2: Sensitivity analysis: fixed‐effect model, Effect 5: Postoperative complications

Summary of findings 1.Whatsoever type of in‐bag morcellation versus uncontained power morcellation during laparoscopic myomectomy

Any type of in‐purse morcellation versus uncontained power morcellation during laparoscopic myomectomy
Patient or population: premenopausal women undergoing laparoscopic myomectomy for uterine fibroids Setting: university hospitals in Italy Intervention: any type of in‐bag morcellation Comparison: uncontained ability morcellation
Outcomes	Predictable absolute furnishings* (95% CI)		Relative event (95% CI)	№ of participants (studies)	Certainty of the evidence (Class)	Comments
	Risk with uncontained power morcellation	Hazard with any type of in‐bag morcellation
Blended intraoperative complications	No intraoperative complications occurred in either group in either trial.			176 (2 RCTs)	⊕⊝⊝⊝ Very depressiona,b	The evidence is very uncertain about the outcome of in‐bag morcellation on blended intraoperative complications.
Full operative time (minutes)	The mean total operative time for the control grouping was 94.41 minutes	The hateful total operative time for the intervention group was 105.1 minutes (ranging from 96.96 to 113.24 minutes)	Md 9.93 (‐1.35 to 21.20)	176 (2 RCTs)	⊕⊝⊝⊝ Very lowa,c	The evidence is very uncertain most the effect of in‐pocketbook morcellation on total operative time
Morcellation operative time (minutes)	The hateful morcellation operative times for the control grouping was 10.26 minutes	The mean morcellation operative times for the intervention group was 12.83 minutes (ranging from 9.47 to xvi.18 minutes)	Doctor two.59 (0.45 to 4.72)	176 (two RCTs)	⊕⊝⊝⊝ Very lowa,c	The evidence is very uncertain about the effect of in‐bag morcellation on morcellation operative time
Ease of morcellation (calibration one to 10; one = very hard, 10 = very piece of cake)	The hateful ease of morcellation score for the control group was 7.five	The mean ease of morcellation score for the intervention grouping was vi.77	Physician ‐0.73 (‐ane.64 to 0.eighteen)	104 (1 RCT)	⊕⊝⊝⊝ Very lowa,c	The prove is very uncertain virtually the event of in‐bag morcellation on ease of morcellation
Postoperative diagnosis of leiomyosarcoma	In that location were no postoperative diagnoses of leiomyosarcoma made in either group in either trial.			176 (2 RCTs)	⊕⊝⊝⊝ Very lowa,b	The testify is very uncertain about the outcome of in‐bag morcellation on postoperative diagnosis of leiomyosarcoma.
*The risk in the intervention grouping (and its 95% confidence interval) is based on the assumed risk in the comparing grouping and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; MD: Mean Difference
Form Working Group grades of evidence High certainty. We are very confident that the true effect lies close to that of the approximate of the effect. Moderate certainty. We are moderately confident in the outcome estimate; the truthful event is probable to be shut to the estimate of the issue, but there is a possibility that it is substantially different. Low certainty. Our confidence in the issue estimate is limited; the true effect may be essentially different from the estimate of the issue. Very depression certainty. Nosotros take very petty confidence in the effect gauge; the true effect is likely to be substantially unlike from the estimate of effect.
adowngraded once for indirectness; all the included trials took place in high‐income settings and countries bdowngraded twice for very serious imprecision; zero events, small sample size cdowngraded twice for very serious imprecision; pocket-sized sample size, wide confidence interval

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Summary of findings 1.Whatsoever blazon of in‐bag morcellation versus uncontained power morcellation during laparoscopic myomectomy

Comparing i.Any type of in‐bag morcellation versus uncontained ability morcellation

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Upshot size
1.one Composite intraoperative complications Prove forest plot	2	176	Run a risk Ratio (1000‐H, Random, 95% CI)	Not estimable
1.2 Total operative time Prove forest plot	2	176	Hateful Difference (Four, Random, 95% CI)	ix.93 [‐1.35, 21.20]
1.iii Morcellation operative time Evidence forest plot	2	176	Mean Deviation (4, Random, 95% CI)	2.59 [0.45, iv.72]
one.iv Ease of morcellation Show forest plot	i		Mean Difference (Four, Random, 95% CI)	Subtotals only
ane.five Postoperative length of stay Show forest plot	2	176	Mean Difference (Iv, Random, 95% CI)	0.03 [‐0.42, 0.49]
1.half-dozen Postoperative pain Evidence forest plot	2	176	Mean Divergence (IV, Random, 95% CI)	0.22 [‐0.50, 0.94]
ane.7 Conversion to laparotomy Show wood plot	ii	176	Adventure Ratio (M‐H, Random, 95% CI)	Not estimable
one.eight Postoperative diagnosis of leiomyosarcoma Show forest plot	2	176	Take chances Ratio (M‐H, Random, 95% CI)	Non estimable
1.9 Postoperative complications Show forest plot	2	176	Gamble Ratio (G‐H, Random, 95% CI)	0.80 [0.xvi, iv.12]

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Comparison 1.Any type of in‐bag morcellation versus uncontained power morcellation

Comparison ii.Sensitivity assay: fixed‐issue model

Upshot or subgroup championship	No. of studies	No. of participants	Statistical method	Effect size
2.1 Total operative time Show forest plot	2	176	Hateful Deviation (IV, Fixed, 95% CI)	9.52 [0.53, 18.51]
2.2 Morcellation operative fourth dimension Show woods plot	2	176	Hateful Difference (IV, Stock-still, 95% CI)	two.59 [0.45, 4.72]
2.3 Postoperative length of stay Show forest plot	2	176	Mean Deviation (Iv, Fixed, 95% CI)	‐0.05 [‐0.25, 0.15]
2.4 Postoperative pain Bear witness forest plot	2	176	Mean Difference (IV, Fixed, 95% CI)	0.05 [‐0.27, 0.37]
two.5 Postoperative complications Bear witness forest plot	2	176	Risk Ratio (M‐H, Fixed, 95% CI)	0.76 [0.16, 3.68]

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Comparing two.Sensitivity analysis: stock-still‐effect model

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Source: https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD013352.pub2/references/ms

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