EndometriosisNCT03457207
Mini Laparotomy With Laparoscopy for Management of Endometrioma
A study testing Combined minilaparotomy- laparoscopy approach in people with Endometriosis, run by Cairo University at 1 site in Egypt.
Trial summary
Under general anaesthesia, the patient is placed in the modified dorsal lithotomy position a 10-mm umbilical trocar is inserted. A panoramic view of the pelvis was obtained together with full assessment of the ovarian mass(es). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Combined minilaparotomy- laparoscopy approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2015to May 2018
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- unilateral or bilateral ovarian endometriotic cysts (≥ 10 cm),
- recurrent ovarian cysts
- good ovarian reserve (antimullerian hormone {AMH} > 1 ng/ml \& antral follicular count {AFC} > 4)
Who cannot join
- solid ovarian masses
- patients who were unfit for surgery
- chronic diseases (e.g. cardiac disease or diabetes)
- any contraindication for laparoscopic surgery (excessive anterior abdominal wall scarring)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy medical school
Cairo, 12111
Ahmed Maged, MD, 01005227404, prof.ahmedmaged@gmail.com
About this study
Official title: Combined Mini Laparotomy With Laparoscopy Appraoch for Management of Endometrioma
Under general anaesthesia, the patient is placed in the modified dorsal lithotomy position a 10-mm umbilical trocar is inserted. A panoramic view of the pelvis was obtained together with full assessment of the ovarian mass(es).
Aspiration of the cyst:
Read more
Veress needle is inserted in the midline 2 cm above the symphysis pubis to aspirate the cyst under laparoscopic guidance (to guide the entry of the needle into the cyst wall \& to confirm complete aspiration).
Delivery of affected ovary outside the abdominal cavity:
Classic ovarian cystectomy will be done using microsurgical techniques in which the cyst wall will be dissected gently and carefully from the healthy ovarian tissue followed by perfect haemostasis and re-fashioning of the remaining ovarian tissue using Vicryl (3-0) sutures.
Re-introduction of the ovary to inside the abdominal cavity:
The stitched ovary is pushed gently inside the abdominal cavity and the minilaparotomy is re-covered by the rubber shield (to allow re-inflation of the abdominal cavity). The ovary is reassessed under laparoscopic guidance to ensure perfect haemostasis and normal position of the ovary. Pelvic irrigation is done if needed.
Read the detailed description
Under general anaesthesia, the patient is placed in themodified dorsal lithotomy position (to ensure lax anterior abdominal wall). The patient is thenprepped and draped in the usual fashion for an abdominaland vaginal procedure. In non- virgin patients, vaginal speculum is inserted into thevagina to expose the cervix, a uterine manipulator is inserted in the cervix followed by placement of a Foley's catheter in thebladder. As regards port placement, a 10-mm umbilical trocar is inserted. A panoramic view of the pelvis was obtained together with full assessment of the ovarian mass(es).
Aspiration of the cyst:
Veress needle is inserted in the midline 2 cm above the symphysis pubis to aspirate the cyst under laparoscopic guidance (to guide the entry of the needle into the cyst wall \& to confirm complete aspiration).
Delivery of affected ovary outside the abdominal cavity:
A transverse mini-laparotomy is done (2-3 cm) in the midline 2 cm above the symphysis pubis. A long shanks artery forceps is introduced inside the abdominal cavity (to grasp the affected ovary) under laparoscopic guidance. Then, the artery is pulled gently to the outside to deliver the ovary at the minilaparotomy skin incision. Careful handling and traction is applied to avoid injury of both the ovarian tissue or/andinfundibulopelvic ligament. Following the delivery of the ovary, the abdominal incision is temporary closed using (Eshaped 10 x 10 cm) rubbershield (to avoid any soiling of abdominal cavity with blood or cystic fluid \& give the chance to reinflate the abdominal cavity later on).
Ovarian cystectomy:
Classic ovarian cystectomy will be done using microsurgical techniques in which the cyst wall will be dissected gently and carefully from the healthy ovarian tissue followed by perfect haemostasis and re-fashioning of the remaining ovarian tissue using Vicryl (3-0) sutures.The stitched ovary is pushed gently inside the abdominal cavity and the minilaparotomy is re-covered by the rubber shield (to allow re-inflation of the abdominal cavity). The ovary is reassessed under laparoscopic guidance to ensure perfect haemostasis and normal position of the ovary. Pelvic irrigation is done if needed
- Conditions
- Endometriosis
- Being tested
- Combined minilaparotomy- laparoscopy approach
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined minilaparotomy- laparoscopy approachProcedure or surgery
Laparoscopic aspiration of cyst then guided its extracorporeal cystectomy then reposition and evaluation by laproscopy
| Study group | Role | What they receive |
|---|---|---|
| combined minilaparotomy- laparoscopy approach | Experimental | women undergo the new technique of surgical treatment of endometriomas of the ovary Receives: Procedure: Combined minilaparotomy- laparoscopy approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrance
reappearance of endometriomas in the ipsilateral ovary
Measured: 2 years after surgery
Secondary outcomes (3)
Ovarian reserve
Measurment of day 2 serum FSH
Measured: 6 months after surgery
Ovarian reserve
measurment of AMH
Measured: 6 months after surgery
ovarian reserve
Measurement of antral follicular count
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start2 Jan 2015
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457207
- Sponsor's protocol ID
- 30
- Status last verified
- Mar 2018
- First submitted
- 25 Feb 2018
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Mini Laparotomy With Laparoscopy Appraoch for Management of Endometrioma
- ClinicalTrials.gov ID
- NCT03457207
- Acronym / sponsor ID
- 30
- Conditions
- Endometriosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Jan 2015 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 7 Mar 2018 (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.
Under general anaesthesia, the patient is placed in the modified dorsal lithotomy position a 10-mm umbilical trocar is inserted. A panoramic view of the pelvis was obtained together with full assessment of the ovarian mass(es).
Aspiration of the cyst:
Veress needle is inserted in the midline 2 cm above the symphysis pubis to aspirate the cyst under laparoscopic guidance (to guide the entry of the needle into the cyst wall \& to confirm complete aspiration).
Delivery of affected ovary outside the abdominal cavity:
Classic ovarian cystectomy will be done using microsurgical techniques in which the cyst wall will be dissected gently and carefully from the healthy ovarian tissue followed by perfect haemostasis and re-fashioning of the remaining ovarian tissue using Vicryl (3-0) sutures.
Re-introduction of the ovary to inside the abdominal cavity:
The stitched ovary is pushed gently inside the abdominal cavity and the minilaparotomy is re-covered by the rubber shield (to allow re-inflation of the abdominal cavity). The ovary is reassessed under laparoscopic guidance to ensure perfect haemostasis and normal position of the ovary. Pelvic irrigation is done if needed.
Detailed description
Under general anaesthesia, the patient is placed in themodified dorsal lithotomy position (to ensure lax anterior abdominal wall). The patient is thenprepped and draped in the usual fashion for an abdominaland vaginal procedure. In non- virgin patients, vaginal speculum is inserted into thevagina to expose the cervix, a uterine manipulator is inserted in the cervix followed by placement of a Foley's catheter in thebladder. As regards port placement, a 10-mm umbilical trocar is inserted. A panoramic view of the pelvis was obtained together with full assessment of the ovarian mass(es).
Aspiration of the cyst:
Veress needle is inserted in the midline 2 cm above the symphysis pubis to aspirate the cyst under laparoscopic guidance (to guide the entry of the needle into the cyst wall \& to confirm complete aspiration).
Delivery of affected ovary outside the abdominal cavity:
A transverse mini-laparotomy is done (2-3 cm) in the midline 2 cm above the symphysis pubis. A long shanks artery forceps is introduced inside the abdominal cavity (to grasp the affected ovary) under laparoscopic guidance. Then, the artery is pulled gently to the outside to deliver the ovary at the minilaparotomy skin incision. Careful handling and traction is applied to avoid injury of both the ovarian tissue or/andinfundibulopelvic ligament. Following the delivery of the ovary, the abdominal incision is temporary closed using (Eshaped 10 x 10 cm) rubbershield (to avoid any soiling of abdominal cavity with blood or cystic fluid \& give the chance to reinflate the abdominal cavity later on).
Ovarian cystectomy:
Classic ovarian cystectomy will be done using microsurgical techniques in which the cyst wall will be dissected gently and carefully from the healthy ovarian tissue followed by perfect haemostasis and re-fashioning of the remaining ovarian tissue using Vicryl (3-0) sutures.The stitched ovary is pushed gently inside the abdominal cavity and the minilaparotomy is re-covered by the rubber shield (to allow re-inflation of the abdominal cavity). The ovary is reassessed under laparoscopic guidance to ensure perfect haemostasis and normal position of the ovary. Pelvic irrigation is done if needed
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| combined minilaparotomy- laparoscopy approach | Experimental | Procedure: Combined minilaparotomy- laparoscopy approachwomen undergo the new technique of surgical treatment of endometriomas of the ovary |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- unilateral or bilateral ovarian endometriotic cysts (≥ 10 cm),
- recurrent ovarian cysts
- good ovarian reserve (antimullerian hormone {AMH} > 1 ng/ml \& antral follicular count {AFC} > 4)
Key exclusion criteria (4 listed)
- solid ovarian masses
- patients who were unfit for surgery
- chronic diseases (e.g. cardiac disease or diabetes)
- any contraindication for laparoscopic surgery (excessive anterior abdominal wall scarring)
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 |
|---|---|---|
| Combined minilaparotomy- laparoscopy approachLaparoscopic aspiration of cyst then guided its extracorporeal cystectomy then reposition and evaluation by laproscopy | Procedure or surgery | combined minilaparotomy- laparoscopy approach |
Primary outcome
Recurrance
Time frame: 2 years after surgery
reappearance of endometriomas in the ipsilateral ovary
3 secondary outcomes
Ovarian reserve
Time frame: 6 months after surgery
Ovarian reserve
Time frame: 6 months after surgery
ovarian reserve
Time frame: 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- 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.
Ahmed Maged, MD principal investigator
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined minilaparotomy- laparoscopy approach in people with Endometriosis, run by Cairo University 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Mar 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Maged, MD (+2001005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrance (time frame: 2 years after surgery). 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 7 Mar 2018.