NCT03009812

Brief Summary

The Aim of the study is to compare between transverse and longitudinal uterine incision in abdominal myomectomy regarding intraoperative blood loss.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

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

January 1, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 4, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2018

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

1 year

First QC Date

January 1, 2017

Last Update Submit

April 5, 2019

Conditions

Myoma;Uterus

Outcome Measures

Primary Outcomes (1)

  • Intraoperative blood loss

    1 year

Study Arms (2)

Group 1

ACTIVE COMPARATOR

26 subjects who are planned for transverse uterine incision

Procedure: Transverse uterine incision

Group 2

ACTIVE COMPARATOR

26 subjects who are planned for longitudinal uterine incision

Procedure: Longitudinal uterine incision

Interventions

Longitudinal uterine incisionPROCEDURE
Group 2
Transverse uterine incisionPROCEDURE
Group 1

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Single myoma.
  • Women with BMI between 18.5-29.9 kg/m2.

You may not qualify if:

  • Pregnancy.
  • Patients with bleeding tendency
  • Previous laparotomies.
  • Patients with concomitant pelvic pathologies, such as ovarian cysts.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Elguindy A, Hemeda H, Shawky ME, Elsenity M, Elsayed MA, Fahim A, Afifi K, Nawara M. Blood loss from transverse versus longitudinal uterine incision in abdominal myomectomy: a randomized controlled trial. BMC Womens Health. 2020 Dec 28;20(1):259. doi: 10.1186/s12905-020-01113-3.

    PMID: 33357218DERIVED

MeSH Terms

Conditions

Myofibroma

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue Diseases

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
Principle investigator

Study Record Dates

First Submitted

January 1, 2017

First Posted

January 4, 2017

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

January 23, 2018

Last Updated

April 8, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share