Laparoendoscopic Single-site Surgery Versus Conventional Multi-port Laparoscopy in Ovarian Drilling: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ain Shams Maternity Hospital
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- successful surgical procedure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, 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.
Eligibility Criteria
- Ages
- 16 Years to 50 Years (Child, Adult)
- Sex
- Female
- Accepts 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.
Arms & Interventions
LESS surgery
Laparoscopic ovarian drilling for polycystic ovary syndrome in infertile women using laparoendoscopic single-site surgery (single incision through the umbilicus using modified Hasson technique).
Intervention: laparoscopic ovarian drilling (Device)
conventional multi-port laparoscopy
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).
Intervention: laparoscopic ovarian drilling (Device)
Outcomes
Primary Outcomes
successful surgical procedure
Time Frame: 1 hour (minutes)
without conversion to laparotomy or the use of an additional port in the single-site group (number of ports).
Secondary Outcomes
- intraoperative blood loss(24 hour after end of procedure)
- cosmetic outcome(day 1 and day 7)
- postoperative pain(1st day)
- intraoperative complications(1 hour)
- operative time(1 hour (minutes))
- postoperative hospital stay(3 days)
- postoperative complications(1st week)
Investigators
Ahmed Mohamed Bahaa Eldin Ahmed
assistant professor
Ain Shams Maternity Hospital