Clinical trial NCT03206892: LESS Surgery Versus Conventional Multiport Laparoscopy in Ovarian Drilling
Official title: Laparoendoscopic Single-site Surgery Versus Conventional Multi-port Laparoscopy in Ovarian Drilling: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Successful Surgical Procedure
Operative Time
Cosmetic Outcome
Intra- and Post- Operative Complications
Keywords: LESS surgery
conventional multi-port laparoscopy
SILS
Single-site surgery
Covidien
laparoscopy
minimally invasive surgery
ovarian drilling
PCOS
Diagnostic laparoscopy
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 70
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: successful surgical procedure
timeFrame: 1 hour (minutes)
Secondary outcomes:
measure: operative time
timeFrame: 1 hour (minutes)
measure: intraoperative blood loss
timeFrame: 24 hour after end of procedure
measure: intraoperative complications
timeFrame: 1 hour
measure: postoperative hospital stay
timeFrame: 3 days
measure: postoperative pain
timeFrame: 1st day
measure: postoperative complications
timeFrame: 1st week
measure: cosmetic outcome
timeFrame: day 1 and day 7
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
affiliation: Ain Shams University
name: Hesham M. Fathy, MD
role: STUDY_CHAIR
affiliation: Ain Shams University
name: Ahmed M. Bahaa Eldin, MD
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Haitham Fathy M., MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University
name: Maya M. AbdelRazek, M. Sc.
role: PRINCIPAL_INVESTIGATOR
References: