Endometriosis Clinical Trial
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:
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | May 2018 |
Est. primary completion date | May 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - 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) 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) |
Country | Name | City | State |
---|---|---|---|
Egypt | Kasr Alainy medical school | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrance | reappearance of endometriomas in the ipsilateral ovary | 2 years after surgery | |
Secondary | Ovarian reserve | Measurment of day 2 serum FSH | 6 months after surgery | |
Secondary | Ovarian reserve | measurment of AMH | 6 months after surgery | |
Secondary | ovarian reserve | Measurement of antral follicular count | 6 months after surgery |
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