- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03370952
Laparoscopy-assisted Ovarian Cystectomy: NEW APPROCH
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 mini-laparotomy 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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patient positioning and port placement:
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 mini-laparotomy 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 (E-shaped 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.
Re-introduction of the ovary to inside the abdominal cavity:
The stitched ovary is pushed gently inside the abdominal cavity and the mini-laparotomy 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt, 12151
- Kasr Alainy medical school
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- unilateral or bilateral ovarian cysts (≥ 10 cm),
- recurrent ovarian cysts
- good ovarian reserve (antimullerian hormone {AMH} > 1 ng/ml & antral follicular count {AFC} > 4)
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: new approach
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: 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. Ovarian cystectomy: Re-introduction of the ovary to inside the abdominal cavity: |
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:Delivery of affected ovary outside the abdominal cavity: Ovarian cystectomy: Re-introduction of the ovary to inside the abdominal cavity: |
Active Comparator: Laproscopic ovarian cystectomy
classic laparoscopic ovarian cystectomy
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laparoscopic ovarian cystectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
recurrence of ovarian masses
Time Frame: 6 months after the operation
|
recurrence was defined as the presence of ovarian cysts ≥2 cm in the ipsilateral ovary
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6 months after the operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
serum follicle stimulating hormone
Time Frame: 6 months after the operation
|
Measurement of FSH on 2nd day of a natural cycle as a marker of ovarian reserve
|
6 months after the operation
|
Serum antimullerian hormone
Time Frame: 6 months after the operation
|
Measurement of AMH on 2nd day of a natural cycle as a marker of ovarian reserve
|
6 months after the operation
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ahmed Maged, MD, Professor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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