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laparoendoscopic single-site surgery is compared to conventional multi-port laparoscopy for polycystic ovary syndrome in infertile women undergoing ovarian drilling as regards successful surgical procedure with less side effects
Laparoendoscopic single-site surgery; one of the most recent advances in the field of minimally invasive surgery, is the use of a single incision in the umbilicus for laparoscopic surgeries, is compared to the conventional multi-port laparoscopy for polycystic ovary syndrome in infertile women undergoing ovarian drilling as regards successful surgical procedure without conversion to laparotomy or use of an additional port in the single site group. in addition to operative time, intra- and post- operative complications and cosmetic outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LESS surgery | Experimental | Laparoscopic ovarian drilling for polycystic ovary syndrome in infertile women using laparoendoscopic single-site surgery (single incision through the umbilicus using modified Hasson technique). |
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| conventional multi-port laparoscopy | Active Comparator | laparoscopic ovarian drilling for polycystic ovary syndrome in infertile women using conventional multi-port laparoscopy (three port system using a closed technique on the umbilicus, left and right lower quadrant areas). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic ovarian drilling | Device | laparoscopic ovarian drilling for polycystic ovary syndrome in infertile women comparing LESS surgery to conventional multiport laparoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| successful surgical procedure | without conversion to laparotomy or the use of an additional port in the single-site group (number of ports). | 1 hour (minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| operative time | from trocar insertion to last skin stitch (minutes) | 1 hour (minutes) |
| intraoperative blood loss | amount of blood in the suction bottle (mL), drop in postoperative haemoglobin (g/dl) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hesham M. Fathy, MD | Ain Shams University | Study Chair |
| Ahmed M. Bahaa Eldin, MD | Ain Shams University | Study Director |
| Haitham Fathy M., MD | Ain Shams University | Principal Investigator |
| Maya M. AbdelRazek, M. Sc. | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Maternity Hospital | Cairo | 00202 | Egypt |
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women fulfilled the inclusion criteria and consented will be included in the study and randomly assigned into two groups using computer random sequence generator.
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using sequentially numbered, opaque sealed enveloped; each envelope contains the method of intervention according to the random sequence and will be opened just before the intervention.
| 24 hour after end of procedure |
| intraoperative complications | blood transfusion (number of units), bowel, bladder or ureteric injuries | 1 hour |
| postoperative hospital stay | number of days | 3 days |
| postoperative pain | visual analogue scale (0-10 scale), number of postoperative analgesic ampules needed | 1st day |
| postoperative complications | hematoma, wound infection, ileus, UTI | 1st week |
| cosmetic outcome | scar image | day 1 and day 7 |