NCT07308197

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

December 15, 2025

Last Update Submit

December 15, 2025

Conditions

Keywords

hystrectomyposterior colopotomyVaginal length

Outcome Measures

Primary Outcomes (1)

  • Total vaginal length

    calculated according to the formula TVS=Preoperative VL-Postoperative VL

    after 3 months

Study Arms (2)

Group A (Classic technique):

ACTIVE COMPARATOR

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

Procedure: Abdominal hysterectomy

Group B (posterior colpotomy first) approach

ACTIVE COMPARATOR

entering the vagina via the posterior wall at the uppermost part of the uterosacral ligaments, followed by the left lateral fornix

Procedure: Abdominal hysterectomy

Interventions

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 (Classic technique):Group B (posterior colpotomy first) approach

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, Cairo Governorate, 12111, Egypt

Location

Study Officials

  • Ahmed Maged

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 15, 2025

First Posted

December 29, 2025

Study Start

March 30, 2023

Primary Completion

March 25, 2024

Study Completion

September 16, 2024

Last Updated

December 29, 2025

Record last verified: 2025-12

Locations