LESS Surgery Versus Conventional Multiport Laparoscopy in Ovarian Drilling

Ain Shams Maternity Hospital

Status: Completed

Conditions: Intra- and Post- Operative Complications; Cosmetic Outcome; Operative Time; Successful Surgical Procedure

Treatments: Device: laparoscopic ovarian drilling

Study type: Interventional

Funder types: Other

Identifiers

NCT03206892

LESS surgery AinShamsMH

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 patients

Sex: Female

Ages: 16 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

LESS surgery

Experimental group

Description:

Laparoscopic ovarian drilling for polycystic ovary syndrome in infertile women using laparoendoscopic single-site surgery (single incision through the umbilicus using modified Hasson technique).

Treatment:

Device: laparoscopic ovarian drilling

conventional multi-port laparoscopy

Active Comparator group

Description:

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).

Treatment:

Device: laparoscopic ovarian drilling