LESS Surgery Versus Conventional Multiport Laparoscopy in Ovarian Drilling

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

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

Study Overview

• Status: Completed
• Conditions: Cosmetic Outcome; Operative Time; Successful Surgical Procedure; Intra- and Post- Operative Complications
• Intervention / Treatment: Device: laparoscopic ovarian drilling

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 00202
    • Ain shams university maternity hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LESS surgery; 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; laparoscopic ovarian drilling for polycystic ovary syndrome in infertile women comparing LESS surgery to conventional multiport laparoscopy
Active Comparator: conventional multi-port laparoscopy; 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; laparoscopic ovarian drilling for polycystic ovary syndrome in infertile women comparing LESS surgery to conventional multiport laparoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital
• Investigators: Study Chair: Hesham M. Fathy, MD, Ain Shams University; Study Director: Ahmed M. Bahaa Eldin, MD, Ain Shams University; Principal Investigator: Haitham Fathy M., MD, Ain Shams University; Principal Investigator: Maya M. AbdelRazek, M. Sc., Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): June 27, 2019
• Last Update Submitted That Met QC Criteria: June 26, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: PCOS; laparoscopy; SILS; minimally invasive surgery; Diagnostic laparoscopy; ovarian drilling; LESS surgery; conventional multi-port laparoscopy; Single-site surgery; Covidien
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: LESS surgery AinShamsMH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No