Successful Surgical ProcedureNCT03206892
LESS Surgery Versus Conventional Multiport Laparoscopy in Ovarian Drilling
A study testing laparoscopic ovarian drilling in people with Successful Surgical Procedure and Operative Time, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Successful Surgical Procedure, Operative Time, Cosmetic Outcome
- What is being tested?
- laparoscopic ovarian drilling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2017to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Successful Surgical Procedure, Operative Time, Cosmetic Outcome, Intra- and Post- Operative Complications
- Being tested
- laparoscopic ovarian drilling
- Keywords
- LESS surgery, conventional multi-port laparoscopy, SILS, Single-site surgery, Covidien, laparoscopy, minimally invasive surgery, ovarian drilling, PCOS, Diagnostic laparoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic ovarian drillingDevice
laparoscopic ovarian drilling for polycystic ovary syndrome in infertile women comparing LESS surgery to conventional multiport laparoscopy
| Study group | Role | What they receive |
|---|---|---|
| LESS surgery | Experimental | Laparoscopic ovarian drilling for polycystic ovary syndrome in infertile women using laparoendoscopic single-site surgery (single incision through the umbilicus using modified Hasson technique). Receives: Device: laparoscopic ovarian drilling |
| conventional multi-port laparoscopy | Active comparator | 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). Receives: Device: laparoscopic ovarian drilling |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful surgical procedure
without conversion to laparotomy or the use of an additional port in the single-site group (number of ports).
Measured: 1 hour (minutes)
Secondary outcomes (7)
operative time
from trocar insertion to last skin stitch (minutes)
Measured: 1 hour (minutes)
intraoperative blood loss
amount of blood in the suction bottle (mL), drop in postoperative haemoglobin (g/dl)
Measured: 24 hour after end of procedure
intraoperative complications
blood transfusion (number of units), bowel, bladder or ureteric injuries
Measured: 1 hour
postoperative hospital stay
number of days
Measured: 3 days
postoperative pain
visual analogue scale (0-10 scale), number of postoperative analgesic ampules needed
Measured: 1st day
postoperative complications
hematoma, wound infection, ileus, UTI
Measured: 1st week
cosmetic outcome
scar image
Measured: day 1 and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Aug 2017
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Successful Surgical ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Bahaa Eldin Ahmed, Ain Shams Maternity Hospital
- Investigators
- Hesham M. Fathy, MD, Study chair, Ain Shams UniversityAhmed M. Bahaa Eldin, MD, Study director, Ain Shams UniversityHaitham Fathy M., MD, Principal investigator, Ain Shams UniversityMaya M. AbdelRazek, M. Sc., Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206892
- Sponsor's protocol ID
- LESS surgery AinShamsMH
- Status last verified
- Jun 2019
- First submitted
- 30 Jun 2017
- Last updated
- 27 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoendoscopic Single-site Surgery Versus Conventional Multi-port Laparoscopy in Ovarian Drilling: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03206892
- Acronym / sponsor ID
- LESS surgery AinShamsMH
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| LESS surgery | Experimental | Device: laparoscopic ovarian drillingLaparoscopic ovarian drilling for polycystic ovary syndrome in infertile women using laparoendoscopic single-site surgery (single incision through the umbilicus using modified Hasson technique). |
| conventional multi-port laparoscopy | Active comparator | Device: laparoscopic ovarian drillinglaparoscopic 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). |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic ovarian drillinglaparoscopic ovarian drilling for polycystic ovary syndrome in infertile women comparing LESS surgery to conventional multiport laparoscopy | Device | LESS surgery, conventional multi-port laparoscopy |
Primary outcome
successful surgical procedure
Time frame: 1 hour (minutes)
without conversion to laparotomy or the use of an additional port in the single-site group (number of ports).
7 secondary outcomes
operative time
Time frame: 1 hour (minutes)
intraoperative blood loss
Time frame: 24 hour after end of procedure
intraoperative complications
Time frame: 1 hour
postoperative hospital stay
Time frame: 3 days
postoperative pain
Time frame: 1st day
postoperative complications
Time frame: 1st week
cosmetic outcome
Time frame: day 1 and day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hesham M. Fathy, MD study chair
Ain Shams University
Ahmed M. Bahaa Eldin, MD study director
Ain Shams University
Haitham Fathy M., MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic ovarian drilling in people with Successful Surgical Procedure and Operative Time, run by Ain Shams Maternity Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
successful surgical procedure (time frame: 1 hour (minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019.