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Laparoscopic Versus Vaginal Approach Closure Complications

E

Egymedicalpedia

Status

Enrolling

Conditions

Vaginal Vault Prolapse

Treatments

Procedure: Laparoscopic and Vaginal Hysterectomy

Study type

Interventional

Funder types

Industry

Identifiers

NCT05960292
Mohamed Adel Hussien

Details and patient eligibility

About

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.

Full 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.

Enrollment

56 estimated patients

Sex

Female

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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

  • Patients with known malignancy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

56 participants in 2 patient groups

Vaginal Hysterectomy (Group)
Active Comparator group
Description:
About 28 female patients will have vaginal vault closure by vaginal approach
Treatment:
Procedure: Laparoscopic and Vaginal Hysterectomy
Abdominal Laparoscopic Hysterectomy (Group)
Active Comparator group
Description:
About 28 female patients will have vaginal vault closure by Abdominal Laparoscopic approach
Treatment:
Procedure: Laparoscopic and Vaginal Hysterectomy

Trial contacts and locations

1

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Central trial contact

Mohamed Adel, MSC

Data sourced from clinicaltrials.gov

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