Skip to main content
OpenTrials
Completed

NCT Number: NCT03206892

LESS Surgery Versus Conventional Multiport Laparoscopy in Ovarian Drilling

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

16 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Maternity Hospital

Cairo, 00202, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

laparoscopic ovarian drilling

Device

laparoscopic ovarian drilling for polycystic ovary syndrome in infertile women comparing LESS surgery to conventional multiport laparoscopy

Primary outcomes

  1. 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

  1. operative time

    Time frame: 1 hour (minutes)

    from trocar insertion to last skin stitch (minutes)

  2. intraoperative blood loss

    Time frame: 24 hour after end of procedure

    amount of blood in the suction bottle (mL), drop in postoperative haemoglobin (g/dl)

  3. intraoperative complications

    Time frame: 1 hour

    blood transfusion (number of units), bowel, bladder or ureteric injuries

  4. postoperative hospital stay

    Time frame: 3 days

    number of days

  5. postoperative pain

    Time frame: 1st day

    visual analogue scale (0-10 scale), number of postoperative analgesic ampules needed

  6. postoperative complications

    Time frame: 1st week

    hematoma, wound infection, ileus, UTI

  7. cosmetic outcome

    Time frame: day 1 and day 7

    scar image

Sponsors and collaborators

Lead sponsor

Ain Shams Maternity Hospital

Other

Registry information

Official study title

Laparoendoscopic Single-site Surgery Versus Conventional Multi-port Laparoscopy in Ovarian Drilling: A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 2, 2017
Registry last updated
Jun 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.