LESS Surgery Versus Conventional Multiport Laparoscopy in Ovarian Drilling

Study Overview
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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

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.

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

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

Intervention / Treatment
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* Device: laparoscopic ovarian drilling


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single-site surgery, LESS surgery, conventional multi-port laparoscopy, SILS, Covidien, laparoscopy, minimally invasive surgery, ovarian drilling, PCOS, Diagnostic laparoscopy