Venturella 2016.

Study characteristics
Methods	Unblinded single‐centre 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 18 and 40 years, body mass index (BMI) 18 kg/m² to 40 kg/m², heavy menstrual bleeding, and the presence of at least one myoma measuring 4 cm or more in diameter (but no myoma measuring >10 cm, according to local practice on eligibility for laparoscopy).
Interventions	In the intervention group (extracorporeal in‐bag manual morcellation), each enucleated myoma was placed within a rip‐stop nylon specimen bag (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 30 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 bag from the coring rotational movements of either the knife or the scissors and allowed a more manageable coring. After exteriorisation of the fibroid's surface with the aid of Alexis retractors, it was grasped with Schroeder tenaculum, double tooth, or Backhaus towel forceps and subjected to gradual morcellation with scalpel or scissors by cautious C‐coring. Fibroid adequate traction was allowed by using different instruments, depending on the myoma consistency. In the control group, intracorporeal un‐contained morcellation using a power morcellator (Rotocut G1, Storz) was performed.
Outcomes	The primary 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, University ‘‘Magna Graecia’’ of Catanzaro Clinical Trial Registration: NCT02086435
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated
Allocation concealment (selection bias)	Low risk	sealed, opaque envelopes
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	Low risk	No loss to follow‐up
Selective reporting (reporting bias)	Low risk	No deviation from the original protocol
Other bias	Unclear risk	Insufficient reporting to determine presence of other forms of bias