Successful Surgical Procedure, Operative Time, Cosmetic Outcome, Intra- and Post- Operative Complications
Conditions
Keywords
LESS surgery, conventional multi-port laparoscopy, SILS, Single-site surgery, Covidien, laparoscopy, minimally invasive surgery, ovarian drilling, PCOS, Diagnostic laparoscopy
Brief summary
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
Detailed description
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.
Interventions
laparoscopic ovarian drilling for polycystic ovary syndrome in infertile women comparing LESS surgery to conventional multiport laparoscopy
Sponsors
Ain Shams Maternity Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
women fulfilled the inclusion criteria and consented will be included in the study and randomly assigned into two groups using computer random sequence generator.
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* PCOS according to Rotterdam Criteria (2 out of 3): * polycystic ovaries (12 or more follicles in each ovary and/or increased ovarian volume \>10 cm3). * oligo- or an-ovulation. * clinical and/or biochemical hyperandrogenisim. After exclusion of other aetiologies for irregular cycles. * Indications of laparoscopic ovarian drilling: * clomiphene citrate- resistance or failure: failure to conceive after 6 to 9 cycles. * other indications for laparoscopy. * before gonadotropin administration to decrease risk of OHSS and multiple pregnancy. * before ART to decrease risk of severe OHSS in women who previously had canceled IVF cycles due to OHSS risk or who suffered from OHSS in a previous treatment.
Exclusion criteria
* previous 2 or more laparotomies. * chronic pelvic pain, endometriosis or pelvic inflammatory diseases to avoid pelvic adhesions and bias in the quantification of postoperative pain. * High BMI (\>35kg/m2) * do not possess a native umbilicus. * advanced gynaecological surgeries or malignant disorders (TLH, ALVH, laparoscopic myomectomy). * contraindication to any laparoscopy like any medical condition worsened by pneumoperitoneum or Trendelnburg position.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| successful surgical procedure | 1 hour (minutes) | without conversion to laparotomy or the use of an additional port in the single-site group (number of ports). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative blood loss | 24 hour after end of procedure | amount of blood in the suction bottle (mL), drop in postoperative haemoglobin (g/dl) |
| intraoperative complications | 1 hour | blood transfusion (number of units), bowel, bladder or ureteric injuries |
| postoperative hospital stay | 3 days | number of days |
| operative time | 1 hour (minutes) | from trocar insertion to last skin stitch (minutes) |
| postoperative complications | 1st week | hematoma, wound infection, ileus, UTI |
| cosmetic outcome | day 1 and day 7 | scar image |
| postoperative pain | 1st day | visual analogue scale (0-10 scale), number of postoperative analgesic ampules needed |
Countries
Egypt
Outcome results
None listed