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Laparoscopic Versus Transvaginal Cuff Closure

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ClinicalTrials.gov Identifier: NCT03898726
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
amr saad mahmoud, El-Galaa Military Medical Complex

Brief Summary:

It is still debatable whether that the transvaginal approach to vault closure or laparoscopic suturing are associated with lower risks of vaginal cuff complications .

This study aims to compare the two approaches of closure of the vaginal cuff at the end of total laparoscopic hysterectomy as regards the vaginal cuff complications .


Condition or disease Intervention/treatment Phase
Vaginal Cuff Dehiscence Vaginal Hematoma Vaginal Infection Biological: laparoscopical l cuff closure Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison Between Laparoscopic Versus Transvaginal Cuff Closure After Total Laparoscopic Hysterectomy
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Active Comparator: laparoscopical l cuff closure
needle holder laparoscopic vaginal cuff closure
Biological: laparoscopical l cuff closure
closure of vaginal cuff following hysterectomy
Other Name: transvaginal cuff closure

Active Comparator: transvaginal cuff closure
transvaginal cuff closure
Biological: laparoscopical l cuff closure
closure of vaginal cuff following hysterectomy
Other Name: transvaginal cuff closure




Primary Outcome Measures :
  1. 1. number of cases ofVaginal cuff dehiscence [ Time Frame: 3 months ]
    Any separation at the level of the vaginal vault.


Secondary Outcome Measures :
  1. number of cases with vaginal hematoma [ Time Frame: 3 months ]
    ultrasound finding

  2. number of cases with vaginal infection [ Time Frame: 3 months ]
    purulent vaginal discharge



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients candidate for total laparoscopic hysterectomy :

    • Uterine size <12 weeks.
    • Having no severe endometriosis.
    • Having descent of no more than 1st degree of uterus.
    • Non-malignant conditions.
  2. Completion of the entire procedure by laparoscopic approach up to colpotomy.
  3. Benign conditions as indications for hysterectomy.

Exclusion Criteria:

- 1) Obese patients i.e., BMI > 30 k.g\m2. 2) Suspected extensive pelvic adhesions . 3) Factors which may prolong wound healing as uncontrolled diabetes, ,prolonged corticosteroid therapy ,advanced liver diseases.

4) Inability to express adequate informed consent to participate in the study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898726


Contacts
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Contact: amr saad, MSC 01010051381 amrsaadobygyn@gmail.com
Contact: Ahmed Saad 01113303665 ahmedsaad2910@gmail.com

Locations
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Egypt
Ain Shams university Recruiting
Cairo, Egypt, 11111
Sponsors and Collaborators
El-Galaa Military Medical Complex

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Responsible Party: amr saad mahmoud, assistant lecturer, El-Galaa Military Medical Complex
ClinicalTrials.gov Identifier: NCT03898726     History of Changes
Other Study ID Numbers: ElGalaa
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hematoma
Hemorrhage
Pathologic Processes