Laparoscopy-assisted Ovarian Cystectomy: NEW APPROCH
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- recurrence of ovarian masses
Study Overview
Brief 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).
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.
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:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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:
Intervention: combined laproscopic and minilaparotomy ovarian cystectomy (Procedure)
Laproscopic ovarian cystectomy
classic laparoscopic ovarian cystectomy
Intervention: laproscopy (Procedure)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Serum antimullerian hormone(6 months after the operation)
- serum follicle stimulating hormone(6 months after the operation)
Investigators
Ahmed M Maged, MD
professor
Cairo University