CClinicalTrials.gg
RecruitingNCT05960292Updated Sep 7, 2023

Laparoscopic Versus Vaginal Approach Closure Complications

An interventional study of Laparoscopic and Vaginal Hysterectomy in Vaginal Vault Prolapse, sponsored by Egymedicalpedia. Recruiting at 1 site in Egypt. Open to female participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-07.

Sponsored by Egymedicalpedia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 6 months ago, but the record still lists the study as recruiting.
  • Started Aug 2023; still recruiting 3 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
Female
01

Study 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.

Read the detailed description

Laparoscopic hysterectomy (LH) is a minimally invasive operation that could be made when vaginal hysterectomy is not accessible due to anatomical problems.

Vaginal cuff dehiscence (VCD) is a severe adverse event and occurs more frequently after total laparoscopic hysterectomy (TLH) compared with abdominal and vaginal hysterectomy.

The study shows effects of the laparoscopic approach versus the vaginal route for the management of vaginal cuff closure during total laparoscopic hysterectomy on female sexual function.

02

Conditions studied

  • Vaginal Vault Prolapse

Keywords

  • Laparoscopic hysterectomy
  • Vaginal hysterectomy
03

In context

Prolapse

676 studies on the registry are indexed under Prolapse; 79 are open to participants now.

This study's planned enrollment of 56 is below the median of 74 across 435 interventional studies indexed under Prolapse.

Browse Prolapse studies →

Lead sponsor

Egymedicalpedia is the lead sponsor of 53 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients who undergo laparoscopic hysterectomy
  2. Age ranged from 40 to 80 years.
  3. Patients suffering from chronic pelvic inflammatory disease (PID)
  4. Dysfunctional uterine bleeding
  5. Adenomyosis
  6. Endometriosis
  7. Fibroid
  8. Endometrial hyperplasia
  9. Benign ovarian cyst

Exclusion criteria

Exclusion Criteria:

  • Patients with known malignancy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
56 participants (estimated)

Study arms

  • Active comparator
    Vaginal Hysterectomy (Group)

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

    Procedure: Laparoscopic and Vaginal Hysterectomy

  • Active comparator
    Abdominal Laparoscopic Hysterectomy (Group)

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

    Procedure: Laparoscopic and Vaginal Hysterectomy

Interventions

  • ProcedureLaparoscopic and Vaginal Hysterectomy

    To make a comparison between the Vaginal Vault complications after Hysterectomy

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: First 24 hours after The Operations

  2. 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

    Time frame: First 24 hours after The Operations

07

Study locations

1 of 1 sites recruiting
  • Al-Azhar University hospitals
    Cairo, 13111, Egypt
    • ElSayed ElDesouky, Assist.Prof · Contact · elsayedeldesouky@yahoo.com · 01092934978
    • Ahmed Altaf, Professor · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05960292
Lead sponsor
Egymedicalpedia
Responsible party
Sponsor
First posted
Jul 25, 2023
Start date
Aug 1, 2023
Primary completion
Apr 1, 2024 (estimated)
Completion
Apr 30, 2024 (estimated)
Last update
Sep 7, 2023

Study contacts

Mohamed Adel, MSC
Contact
elhoseeeeeeny@gmail.com
+201065702255
ElSayed ElDesouky, Assist.Prof.
principal investigator · Al-Azhar University, Faculty of medicine for boys

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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