LESS Surgery Versus Conventional Multiport Laparoscopy in Ovarian Drilling

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-06-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Successful Surgical Procedure Operative Time Cosmetic Outcome Intra- and Post- Operative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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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).

Group Type EXPERIMENTAL

laparoscopic ovarian drilling

Intervention Type DEVICE

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

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).

Group Type ACTIVE_COMPARATOR

laparoscopic ovarian drilling

Intervention Type DEVICE

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

Interventions

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laparoscopic ovarian drilling

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes