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: Completed
• Conditions: Ovarian Cysts
• Intervention / Treatment: Procedure: combined laproscopic and minilaparotomy ovarian cystectomy; Procedure: laproscopy

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: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12151
    • Kasr Alainy Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

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)

Number of Arms

2

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:	Procedure: combined 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:
Active Comparator: Laproscopic ovarian cystectomy; classic laparoscopic ovarian cystectomy	Procedure: laproscopy; laparoscopic ovarian cystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrence of ovarian masses	recurrence was defined as the presence of ovarian cysts ≥2 cm in the ipsilateral ovary	6 months after the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum follicle stimulating hormone	Measurement of FSH on 2nd day of a natural cycle as a marker of ovarian reserve	6 months after the operation
Serum antimullerian hormone	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: Cairo University
• Investigators: Study Director: Ahmed Maged, MD, Professor

Publications and helpful links

General Publications

• Shaltout MF, Maged AM, Abdella R, Sediek MM, Dahab S, Elsherbini MM, Elkomy RO, Zaki SS. Laparoscopic guided minilaparotomy: a modified technique for management of benign large ovarian cysts. BMC Womens Health. 2022 Jul 4;22(1):269. doi: 10.1186/s12905-022-01853-4.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2017
• Primary Completion (Actual): July 5, 2019
• Study Completion (Actual): August 3, 2019

Study Registration Dates

• First Submitted: December 5, 2017
• First Submitted That Met QC Criteria: December 7, 2017
• First Posted (Actual): December 13, 2017

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 8, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts
• Other Study ID Numbers: 15 (Tishreen_University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No