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Laparoscopy-assisted Ovarian Cystectomy: NEW APPROCH

Laparoscopy-assisted Ovarian Cystectomy: NEW APPROCH

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03370952
Enrollment
112
Registered
2017-12-13
Start date
2017-12-21
Completion date
2019-08-03
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cysts

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: 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.

Interventions

PROCEDURElaproscopy

laparoscopic ovarian cystectomy

PROCEDUREcombined laproscopic and minilaparotomy ovarian cystectomy

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:

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 35 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
recurrence of ovarian masses6 months after the operationrecurrence was defined as the presence of ovarian cysts ≥2 cm in the ipsilateral ovary

Secondary

MeasureTime frameDescription
serum follicle stimulating hormone6 months after the operationMeasurement of FSH on 2nd day of a natural cycle as a marker of ovarian reserve
Serum antimullerian hormone6 months after the operationMeasurement of AMH on 2nd day of a natural cycle as a marker of ovarian reserve

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026