Back to resultsTransverse vs Longitudinal Incision in Myomectomy
Primary Purpose
Myoma;Uterus
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Longitudinal uterine incision
Transverse uterine incision
Sponsored by
About this trial
This is an interventional treatment trial for Myoma;Uterus
Eligibility Criteria
Inclusion Criteria:
- Inclusion criteria for myomectomy as; abnormal uterine, pressure related symptoms, infertility and recurrent pregnancy loss in patients between 18 and 45 years old
- Single myoma.
- Women with BMI between 18.5-29.9 kg/m2.
Exclusion Criteria:
- Pregnancy.
- Patients with bleeding tendency
- Previous laparotomies.
- Patients with concomitant pelvic pathologies, such as ovarian cysts.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
26 subjects who are planned for transverse uterine incision
26 subjects who are planned for longitudinal uterine incision
Outcomes
Primary Outcome Measures
Intraoperative blood loss
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03009812
Brief Title
Transverse vs Longitudinal Incision in Myomectomy
Official Title
Transverse Versus Longitudinal Uterine Incision in Abdominal Myomectomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Aim of the study is to compare between transverse and longitudinal uterine incision in abdominal myomectomy regarding intraoperative blood loss.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myoma;Uterus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
26 subjects who are planned for transverse uterine incision
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
26 subjects who are planned for longitudinal uterine incision
Intervention Type
Procedure
Intervention Name(s)
Longitudinal uterine incision
Intervention Type
Procedure
Intervention Name(s)
Transverse uterine incision
Primary Outcome Measure Information:
Title
Intraoperative blood loss
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria for myomectomy as; abnormal uterine, pressure related symptoms, infertility and recurrent pregnancy loss in patients between 18 and 45 years old
Single myoma.
Women with BMI between 18.5-29.9 kg/m2.
Exclusion Criteria:
Pregnancy.
Patients with bleeding tendency
Previous laparotomies.
Patients with concomitant pelvic pathologies, such as ovarian cysts.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33357218
Citation
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.
Results Reference
derived
Learn more about this trial
Transverse vs Longitudinal Incision in Myomectomy
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