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LESS Surgery Versus Conventional Multiport Laparoscopy in Ovarian Drilling

Primary Purpose

Successful Surgical Procedure, Operative Time, Cosmetic Outcome

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

laparoscopic ovarian drilling

About this trial

This is an interventional diagnostic trial for Successful Surgical Procedure focused on measuring LESS surgery, conventional multi-port laparoscopy, SILS, Single-site surgery, Covidien, laparoscopy, minimally invasive surgery, ovarian drilling, PCOS, Diagnostic laparoscopy

Eligibility Criteria

16 Years - 50 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Ain Shams University Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LESS surgery

conventional multi-port laparoscopy

Arm Description

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

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).

Outcomes

Primary Outcome Measures

successful surgical procedure

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

Secondary Outcome Measures

operative time

from trocar insertion to last skin stitch (minutes)

intraoperative blood loss

amount of blood in the suction bottle (mL), drop in postoperative haemoglobin (g/dl)

intraoperative complications

blood transfusion (number of units), bowel, bladder or ureteric injuries

postoperative hospital stay

number of days

postoperative pain

visual analogue scale (0-10 scale), number of postoperative analgesic ampules needed

postoperative complications

hematoma, wound infection, ileus, UTI

cosmetic outcome

scar image

Full Information

NCT ID

NCT03206892

First Posted

June 30, 2017

Last Updated

June 26, 2019

Sponsor

Ain Shams Maternity Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03206892

Brief Title

LESS Surgery Versus Conventional Multiport Laparoscopy in Ovarian Drilling

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

August 1, 2017 (Actual)

Primary Completion Date

June 1, 2019 (Actual)

Study Completion Date

June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams Maternity Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantOutcomes 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.

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LESS surgery

Arm Type

Experimental

Arm Description

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

Arm Title

conventional multi-port laparoscopy

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

laparoscopic ovarian drilling

Intervention Description

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

Primary Outcome Measure Information:

Title

successful surgical procedure

Description

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

Time Frame

1 hour (minutes)

Secondary Outcome Measure Information:

Title

operative time

Description

from trocar insertion to last skin stitch (minutes)

Time Frame

1 hour (minutes)

Title

intraoperative blood loss

Description

amount of blood in the suction bottle (mL), drop in postoperative haemoglobin (g/dl)

Time Frame

24 hour after end of procedure

Title

intraoperative complications

Description

blood transfusion (number of units), bowel, bladder or ureteric injuries

Time Frame

1 hour

Title

postoperative hospital stay

Description

number of days

Time Frame

3 days

Title

postoperative pain

Description

visual analogue scale (0-10 scale), number of postoperative analgesic ampules needed

Time Frame

1st day

Title

postoperative complications

Description

hematoma, wound infection, ileus, UTI

Time Frame

1st week

Title

cosmetic outcome

Description

scar image

Time Frame

day 1 and day 7

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hesham M. Fathy, MD

Organizational Affiliation

Ain Shams University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ahmed M. Bahaa Eldin, MD

Organizational Affiliation

Ain Shams University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Haitham Fathy M., MD

Organizational Affiliation

Ain Shams University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Maya M. AbdelRazek, M. Sc.

Organizational Affiliation

Ain Shams University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ain Shams University Maternity Hospital

City

Cairo

ZIP/Postal Code

00202

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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LESS Surgery Versus Conventional Multiport Laparoscopy in Ovarian Drilling

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