LESS Surgery Versus Conventional Multiport Laparoscopy in Ovarian Drilling

Sponsor

Ain Shams Maternity Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03206892

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Successful Surgical Procedure Operative Time Cosmetic Outcome Intra- and Post- Operative Complications	Device: laparoscopic ovarian drilling	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Aug 1, 2017

Actual Primary Completion Date :

Jun 1, 2019

Actual Study Completion Date :

Jun 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.