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Clinical Trials/NCT05960292
NCT05960292
Recruiting
Not Applicable

Laparoscopic Versus Vaginal Approach Closure Complications of Vaginal Vault in Laparoscopic Hysterectomy

Egymedicalpedia1 site in 1 country56 target enrollmentStarted: August 1, 2023Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
56
Locations
1
Primary Endpoint
Post operative bleeding (defined as blood loss ≥500 cc)

Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
40 Years to 80 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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
  • Endometrial hyperplasia
  • Benign ovarian cyst

Exclusion Criteria

  • Patients with known malignancy

Outcomes

Primary Outcomes

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

Time Frame: First 24 hours after The Operations

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

Postoperative pain

Time Frame: First 24 hours after The Operations

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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