Comparison Between Electrosurgical Energy and Hemostatic Sealants on Hemostasis in Laparoscopic Ovarian Cystectomy

NCT06913335 | Recruiting

• 1 other identifier: KFSIRB200-504
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare between the effect of using electrosurgical energy and hemostatic sealant for hemostasis in laparoscopic cystectomy for ovarian cysts.

Conditions

Ovarian Cysts

Outcome Measures

Primary Outcomes (1)

• The primary outcome of this study will be the hemostasis time

  The primary outcome of this study will be the hemostasis time

  Day 1

Study Arms (2)

electrosurgical energy group

ACTIVE COMPARATOR

in this group electrosurgical energy will be used to control bleeding

Procedure: laparoscopic ovarian cystectomy using electrosurgical energy

Hemostatic Sealant group

ACTIVE COMPARATOR

in this group Hemostatic Sealant will be used to control bleeding

Procedure: laparoscopic ovarian cystectomy using hemostatic sealant

Interventions

laparoscopic ovarian cystectomy using hemostatic sealant PROCEDURE

* A small incision will be made on the ovarian surface using laparoscopic scissors. * Nontraumatic grasping forceps will be used to dissect the cyst capsule away from the soft tissue of the ovary. * The cyst will be removed intact to avoid spillage of its contents. If rupture occurs, the peritoneal cavity will be irrigated thoroughly. * After the removal of the cyst, the ovarian bed should be inspected for bleeding, and if there is minimal bleeding, using of electrocautery should be avoided to minimize thermal damage to the ovary. * The hemostatic sealant as Surgicel original, Surgicel Fibrillar (ETHICON, USA) which is an absorbable hemostat (oxidized regenerated cellulose) will be applied directly to the bleeding surface 1:5sheets of hemostat will be used.

Hemostatic Sealant group

laparoscopic ovarian cystectomy using electrosurgical energy PROCEDURE

A small incision will be made on the ovarian surface using laparoscopic scissors. * Nontraumatic grasping forceps will be used to dissect the cyst capsule away from the soft tissue of the ovary. * The cyst will be removed intact to avoid spillage of its contents. If rupture occurs, the peritoneal cavity will be irrigated thoroughly. * After the removal of the cyst, the ovarian bed should be inspected for bleeding, and if there is minimal bleeding, using of electrocautery should be avoided to minimize thermal damage to the ovary In the electrosurgical energy using group the hemostasis method will be different and will be achieved using electrosurgical energy. * After the cyst removal and cyst bed examination, any bleeding will be carefully coagulated using bipolar electrosurgical energy * Minimal energy will be applied for short durations to reduce collateral thermal

electrosurgical energy group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥ 18 years old.
• Women with unilateral or bilateral benign ovarian cyst provisionally diagnosed by ultrasound and normal tumor markers.
• Women fit for laparoscopic surgery

You may not qualify if:

• Pregnant women.
• Postmenopausal women.
• Premenarchal girls.
• Women with a history of recent pelvic or abdominal radiotherapy.
• Women with serious concurrent systemic disorders.
• Known ovarian malignancy provisionally diagnosed by ultrasound (US) or tumor markers.
• Women with coagulopathy or bleeding disorders.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Egypt

RECRUITING

MeSH Terms

Conditions

Ovarian Cysts

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Central Study Contacts

Aya Yasser Fawzy, M.B.B.C.H

CONTACT

01097659005; yaya86438@gmail.com

mustafa farag ellkany, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: April 6, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)