Assaf 1999.
| Methods | Single centre study. Patients allocated to trial interventions using a random numbers table (but no description is given of how the table was generated) Neither patients nor care providers were blinded Power calculation: not done No losses to follow up, and all patients were analysed in groups to which they were assigned Source of funding: not mentioned | |
| Participants | Setting: university hospital in Cairo, Egypt Inclusion criteria: infertile patients with fewer than 3 myomas, the largest of which was less than 7 cm, myoma on the anterior wall, subserous‐interstitial myoma, and no procedure other than myomectomy required Exclusion criteria: posterior myoma, subserous myoma only, myoma smaller than 3 cm, operative procedures in addition to myomectomy n = 38 Mean age: 33.4 years (SD 2.2) in both groups Ethnicity: not described Myoma sizes: 30‐70 mm | |
| Interventions | Treatment arm (n = 21): ornipressin injection (5IU) diluted in 100 ml saline was injected to form 2 to 3 weals in the base of the myomas, immediately prior to incision of the uterine capsule
Control group (n = 17): no treatment offered All patients had second‐look laparoscopy 1 month after the original procedure and were then followed up for 1 year Type of operation: laparotomy |
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| Outcomes | Perioperative blood loss, operation time, hospital stay, adhesions, and pregnancy outcome | |
| Notes | Indications for myomectomy: infertility after excluding all other causes except fibroid Authors not contacted |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Patients allocated to trial interventions using a random numbers table (but no description is given of how the table was generated) |
| Allocation concealment (selection bias) | Unclear risk | Unclear |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No incomplete outcome data |
| Selective reporting (reporting bias) | Unclear risk | We do not have access to the study protocol |
| Other bias | Low risk | No other sources of bias identified |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Neither patients nor care providers were blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unblinded |