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

ConditionOvarian Cysts
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorKafrelsheikh University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnant women.

Postmenopausal women.

Premenarchal girls.

Women with a history of recent pelvic or abdominal radiotherapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • laparoscopic ovarian cystectomy using hemostatic sealant

    Procedure/Surgery

    * 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.

  • laparoscopic ovarian cystectomy using electrosurgical energy

    Procedure/Surgery

    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

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: electrosurgical energy groupActive comparator 1 intervention
Group B: Hemostatic Sealant groupActive comparator 1 intervention

Trial outcomes

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

Time frame
Day 1

Secondary outcomes

Other outcomes

Sponsors and contacts

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