NCT03788421

Brief Summary

A comparison between 2 techniques for bilateral salpingectomy during cesarean section. Primary outcomes are total operative time and bilateral completion of the randomized procedure. Secondary outcomes included surgical complications and post operation complications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 27, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

March 10, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

December 25, 2018

Last Update Submit

February 22, 2022

Conditions

Sterility, Female

Outcome Measures

Primary Outcomes (1)

  • Total salpingectomy time.

    Time in minutes from beginning of salpingectomy procedure until end of the salpingectomy procedure.

    Up to 1 week from recruitment

Secondary Outcomes (8)

  • Bleeding during salpingectomy

    Up to 4 hours from the beginning of the procedure

  • Bleeding during cesarean section

    Up to 4 hours from the beginning of the procedure

  • Hemoglobin level

    Up to 5 days from surgery

  • Blood transfusion rate

    Up to 5 days from surgery

  • Postoperative stay

    Up to 2 weeks from surgery

  • +3 more secondary outcomes

Study Arms (2)

Study group

ACTIVE COMPARATOR

Women undergoing elective bilateral salpingectomy during cesarean section with LIGASURE.

Device: LIGASURE

Control group

ACTIVE COMPARATOR

Women undergoing elective bilateral salpingectomy during cesarean section with traditional step by step clamping and suturing.

Procedure: Clamping and suturing

Interventions

LIGASUREDEVICE

Electricity based cautery tool used during both laparoscopic and open surgery for optimal hemostasis.

Study group
Clamping and suturingPROCEDURE

Step by step clamping and suturing of the mesosalpinx until achievement of total salpingectomy.

Control group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants undergoing elective Cesarean Section and are interested and have signed informed consent regarding bilateral salpingectomy.

You may not qualify if:

  • Inability to give informed consent.
  • Preterm delivery (\< 37 weeks' gestation).
  • Fetal demise.
  • Prenatal diagnosis of fetal or placental abnormalities.
  • Previous tubal surgery.
  • The use of anticoagulants.
  • Associated immunosuppressive conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

ConstrictionSutures

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

Investigative TechniquesSurgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Yaniv Zipori, MD

    Rambam healthcare campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 25, 2018

First Posted

December 27, 2018

Study Start

January 1, 2019

Primary Completion

January 1, 2021

Study Completion

September 1, 2021

Last Updated

March 10, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)