NCT05960292

Brief Summary

Hysterectomy is considered as a common operation in Gynecology. Hysterectomy could be made by vaginally, laparoscopically or abdominally. The American Congress of Obstetricians and Gynecologist advises the use of a minimally invasive technique for the sake of women and to decrease hospital stay and costs.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 12, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

8 months

First QC Date

July 12, 2023

Last Update Submit

September 6, 2023

Conditions

Vaginal Vault Prolapse

Keywords

Laparoscopic hysterectomyVaginal hysterectomy

Outcome Measures

Primary Outcomes (2)

  • Post operative bleeding (defined as blood loss ≥500 cc)

    Amount of lost blood will be measured in terms of assessment of Hemoglobin and Hematocrit levels before and after operation.

    First 24 hours after The Operations

  • Postoperative pain

    Assessment of the pain post-operatively in patients with pain score as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain

    First 24 hours after The Operations

Study Arms (2)

Vaginal Hysterectomy (Group)

ACTIVE COMPARATOR

About 28 female patients will have vaginal vault closure by vaginal approach

Procedure: Laparoscopic and Vaginal Hysterectomy

Abdominal Laparoscopic Hysterectomy (Group)

ACTIVE COMPARATOR

About 28 female patients will have vaginal vault closure by Abdominal Laparoscopic approach

Procedure: Laparoscopic and Vaginal Hysterectomy

Interventions

Laparoscopic and Vaginal HysterectomyPROCEDURE

To make a comparison between the Vaginal Vault complications after Hysterectomy

Abdominal Laparoscopic Hysterectomy (Group)Vaginal Hysterectomy (Group)

Eligibility Criteria

Age40 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who undergo laparoscopic hysterectomy
  • Age ranged from 40 to 80 years.
  • Patients suffering from chronic pelvic inflammatory disease (PID)
  • Dysfunctional uterine bleeding
  • Adenomyosis
  • Endometriosis
  • Fibroid
  • Endometrial hyperplasia
  • Benign ovarian cyst

You may not qualify if:

  • Patients with known malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University hospitals

Cairo, 13111, Egypt

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

LaparoscopyHysterectomy, Vaginal

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeHysterectomyGynecologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • ElSayed ElDesouky, Assist.Prof.

    Al-Azhar University, Faculty of medicine for boys

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Adel, MSC

CONTACT

+201065702255elhoseeeeeeny@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2023

First Posted

July 25, 2023

Study Start

August 1, 2023

Primary Completion

April 1, 2024

Study Completion

April 30, 2024

Last Updated

September 7, 2023

Record last verified: 2023-09

Locations

EG(1)