LESS Surgery Versus Conventional Multiport Laparoscopy in Ovarian Drilling

NCT03206892 | Completed

• 1 other identifier: LESS surgery AinShamsMH
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• successful surgical procedure

  without conversion to laparotomy or the use of an additional port in the single-site group (number of ports).

  1 hour (minutes)

Secondary Outcomes (7)

• operative time

  1 hour (minutes)

• intraoperative blood loss

  24 hour after end of procedure

• intraoperative complications

  1 hour

• postoperative hospital stay

  3 days

• postoperative pain

  1st day

Study Arms (2)

LESS surgery

EXPERIMENTAL

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

Device: laparoscopic ovarian drilling

conventional multi-port laparoscopy

ACTIVE COMPARATOR

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).

Device: laparoscopic ovarian drilling

Interventions

laparoscopic ovarian drilling DEVICE

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

LESS surgery; conventional multi-port laparoscopy

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, 00202, Egypt

Location

Study Officials

• Hesham M. Fathy, MD

  Ain Shams University

  STUDY CHAIR

• Ahmed M. Bahaa Eldin, MD

  Ain Shams University

  STUDY DIRECTOR

• Haitham Fathy M., MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

• Maya M. AbdelRazek, M. Sc.

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: women fulfilled the inclusion criteria and consented will be included in the study and randomly assigned into two groups using computer random sequence generator.

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 2, 2017
• Study Start: August 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: June 27, 2019

Record last verified: 2019-06

Locations

EG (1)