- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07308197
Effect of Posterior Colpotomy First Technique on the Vaginal Length During Total Abdominal Hysterectomy
Effect of (Posterior Colpotomy First) Technique on the Vaginal Length During Total Abdominal Hysterectomy
the same surgeon performed all of the procedures using the same method. A lower midline or Pfannestiel incision is the first step in the complete abdominal hysterectomy procedure. They clamp, cut, and ligate the top pedicles. The cardinal and uterosacral ligaments were dissected, the wide ligament's leaves were cut, the bladder was carefully lowered, and the uterine vessels were skeletonized, cut, and tied. Group A (traditional technique): the surgeon makes a circumferential incision after initially entering the front vaginal wall. The surgeon performs a circumferential colpotomy at the topmost section of the vagina using the Group B (posterior colpotomy first) approach, entering the vagina via the posterior wall at the uppermost part of the uterosacral ligaments, followed by the left lateral fornix.
Reconstruction of the pelvic floor to ensure hemostasis and good pelvic support. The operative time was assessed by calculating the time between vaginal cuff opening and suturing after uterine artery ligation, As point D on the POP-Q system is omitted after hysterectomy, point C level was reassessed 2 weeks postoperative.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
the same surgeon performed all of the procedures using the same method. A lower midline or Pfannestiel incision is the first step in the complete abdominal hysterectomy procedure. They clamp, cut, and ligate the top pedicles. The cardinal and uterosacral ligaments were dissected, the wide ligament's leaves were cut, the bladder was carefully lowered, and the uterine vessels were skeletonized, cut, and tied. Group A (traditional technique): the surgeon makes a circumferential incision after initially entering the front vaginal wall. The surgeon performs a circumferential colpotomy at the topmost section of the vagina using the Group B (posterior colpotomy first) approach, entering the vagina via the posterior wall at the uppermost part of the uterosacral ligaments, followed by the left lateral fornix.
Reconstruction of the pelvic floor to ensure hemostasis and good pelvic support. The operative time was assessed by calculating the time between vaginal cuff opening and suturing after uterine artery ligation, As point D on the POP-Q system is omitted after hysterectomy, point C level was reassessed 2 weeks postoperative.
Total vaginal shortening (TVS) and vaginal shortening ratio (VSR) were calculated according to the formulas given below.
TVS=Preoperative VL-Postoperative VL at 3 months. VSP=Preoperative VL-Postoperative VL at 3 months\ Preoperative VL*100
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypt, 12111
- Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ages 40 - 65 years
- sexually active
- BMI of 25-40 kg/m2
- had a fresh abdomen
- had a benign reason for a hysterectomy (multiple fibroid uterus, adenomyosis, or endometrial hyperplasia).
Exclusion Criteria:
- Patients who had vaginal and uterine prolapse,
- subtotal hysterectomy,
- caesarean hysterectomy in patients with major obstetric hemorrhage (placenta previa, accreta-increta-percreta, uncontrolled postpartum hemorrhage)
- malignant indications of total abdominal hysterectomy (uterine and cervical carcinoma)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group A (Classic technique):
the surgeon makes a circumferential incision after initially entering the front vaginal wall.
The surgeon performs a circumferential colpotomy at the topmost section of the vagina
|
A lower midline or Pfannestiel incision is the first step in the complete abdominal hysterectomy procedure.
They clamp, cut, and ligate the top pedicles.
The cardinal and uterosacral ligaments were dissected, the wide ligament's leaves were cut, the bladder was carefully lowered, and the uterine vessels were skeletonized, cut, and tied
|
|
Active Comparator: Group B (posterior colpotomy first) approach
entering the vagina via the posterior wall at the uppermost part of the uterosacral ligaments, followed by the left lateral fornix
|
A lower midline or Pfannestiel incision is the first step in the complete abdominal hysterectomy procedure.
They clamp, cut, and ligate the top pedicles.
The cardinal and uterosacral ligaments were dissected, the wide ligament's leaves were cut, the bladder was carefully lowered, and the uterine vessels were skeletonized, cut, and tied
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total vaginal length
Time Frame: after 3 months
|
calculated according to the formula TVS=Preoperative VL-Postoperative VL
|
after 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmed Maged, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 367
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hysterectomy, Benign Uterine Diseases
-
Cairo UniversityCompletedHysterectomy, Benign Uterine DiseasesEgypt
-
Hanyang University Seoul HospitalCompletedHysterectomy, Benign Uterine Diseases
-
Dr. Lutfi Kirdar Kartal Training and Research HospitalNot yet recruitingHysterectomy | Hysterectomy, Benign Uterine Diseases | Hysterectomy, VaginalTurkey
-
Hospices Civils de LyonCompletedBenign Laparoscopic Hysterectomy | Systematic Salpingectomy
-
Istanbul UniversityUniversity of SurreyCompletedTotal Laparoscopic Hysterectomy | Benign ConditionsTurkey
-
Unity Health TorontoCompletedLaparoscopic Hysterectomy for Benign ConditionsCanada
-
University Hospital, LinkoepingCompletedBenign Hysterectomy | Postoperative Recovery | Preoperative PlanningSweden
-
Johns Hopkins UniversityCompletedRobotic Hysterectomy (Benign Indications/Early-stage Cancer)United States
-
Ethicon Endo-SurgeryCompletedBenign Disease Where Total Hysterectomy is IndicatedUnited States, Netherlands, United Kingdom
-
University Hospital, Strasbourg, FranceUnknownWomen Who Undergo a Laparoscopic Hysterectomy for Benign Disease.France
Clinical Trials on Abdominal hysterectomy
-
South Valley UniversityCompletedProlapse GenitalEgypt
-
Turku University HospitalCompletedAbdominal Hysterectomy (& Wertheim)Finland
-
University Hospital, LinkoepingCompleted
-
St George's Healthcare NHS TrustCompleted
-
University of Texas Southwestern Medical CenterCompletedEndometriosis | Pelvic Pain | Adenomyosis | Metrorrhagia | Pelvic Inflammatory Disease | Leiomyoma | MenorrhagiaUnited States
-
Queensland Centre for Gynaecological CancerNational Health and Medical Research Council, Australia; Johnson & Johnson... and other collaboratorsCompletedEndometrial CancerUnited Kingdom, Australia, Hong Kong, New Zealand
-
Kocaeli UniversityCompletedAbdominal HysterectomyTurkey
-
University Hospital, LinkoepingCompletedEndometrial CancerSweden
-
Hospital Nossa Senhora da ConceicaoCompletedCervical Cancer | Postoperative PainBrazil
-
Parc de Salut MarUnknown