LESS Surgery Versus Conventional Multiport Laparoscopy in Ovarian Drilling

Not Applicable

Completed

• Conditions: Operative Time; Successful Surgical Procedure; Intra- and Post- Operative Complications; Cosmetic Outcome
• Interventions: Device: laparoscopic ovarian drilling

• Registration Number: NCT03206892
• Lead Sponsor: Ain Shams Maternity Hospital

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 Timeline

• Study First Submitted: 2017-06-30
• Study First Submitted QC: 2017-06-30
• Study First Posted: 2017-07-02
• Study Start: 2017-08-01
• Status Verified: 2019-06
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01
• Last Update Submitted: 2019-06-26
• Last Update Posted: 2019-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LESS surgery	laparoscopic ovarian drilling	Laparoscopic ovarian drilling for polycystic ovary syndrome in infertile women using laparoendoscopic single-site surgery (single incision through the umbilicus using modified Hasson technique).
conventional multi-port laparoscopy	laparoscopic ovarian drilling	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
intraoperative complications	1 hour	blood transfusion (number of units), bowel, bladder or ureteric injuries
intraoperative blood loss	24 hour after end of procedure	amount of blood in the suction bottle (mL), drop in postoperative haemoglobin (g/dl)
operative time	1 hour (minutes)	from trocar insertion to last skin stitch (minutes)
postoperative hospital stay	3 days	number of days
postoperative complications	1st week	hematoma, wound infection, ileus, UTI
postoperative pain	1st day	visual analogue scale (0-10 scale), number of postoperative analgesic ampules needed
cosmetic outcome	day 1 and day 7	scar image

Trial Locations

Locations (1)

Ain Shams University Maternity Hospital; 🇪🇬 Cairo, Egypt