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Laparoscopic Ventrosuspension for Women With Retroverted Uterus and Pelvic Pain Syndromes: A New Approach

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03784872
Recruitment Status : Unknown
Verified July 2019 by Ahmed M Maged, MD, Cairo University.
Recruitment status was:  Recruiting
First Posted : December 24, 2018
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed M Maged, MD, Cairo University

Study Description
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Brief Summary:
In women with retroverted retroverted uterus complaining of pelvic pain, Laparoscopy was done. Under vision the skin overlying the attachment of the round ligament to the anterior abdominal wall was incised followed by introduction of 30 curved needle attached to absorpable Vicryl 2/0 suture through the incision and withdrawn through grasper under laparoscopi vision. The needle was turned around the round ligament all through its length to plicate it then the needle was pushed again beside its entry side to appear at the skin incision. The same was repeated on the other side and both sutures were tied at the subcutaneous tissue simultaneously. then the laparoscopy was withdrawn followed by closure of the skin incision.

Condition or disease Intervention/treatment Phase
Chronic Pelvic Pain Procedure: Laparoscopic guided Ventrosuspension Not Applicable

Detailed Description:
In women with retroverted retroverted uterus complaining of pelvic pain, Laparoscopy was done. Under vision the skin overlying the attachment of the round ligament to the anterior abdominal wall was incised followed by introduction of 30 curved needle attached to absorpable Vicryl 2/0 suture through the incision and withdrawn through grasper under laparoscopi vision. The needle was turned around the round ligament all through its length to plicate it then the needle was pushed again beside its entry side to appear at the skin incision. The same was repeated on the other side and both sutures were tied at the subcutaneous tissue simultaneously. then the laparoscopy was withdrawn followed by closure of the skin incision using Vicryl 2/0 suture.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Ventrosuspension for Women With Retroverted Uterus and Pelvic Pain Syndromes: A New Approach
Actual Study Start Date : December 2, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

Arms and Interventions
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Intervention Details:
  • Procedure: Laparoscopic guided Ventrosuspension
    Laparoscopy was done. Under vision the skin overlying the attachment of the round ligament to the anterior abdominal wall was incised followed by introduction of 30 curved needle attached to absorpable Vicryl 2/0 suture through the incision and withdrawn through grasper under laparoscopi vision. The needle was turned around the round ligament all through its length to plicate it then the needle was pushed again beside its entry side to appear at the skin incision. The same was repeated on the other side and both sutures were tied at the subcutaneous tissue simultaneously. then the laparoscopy was withdrawn followed by closure of the skin incision.

Outcome Measures
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Primary Outcome Measures :
  1. Postoperative pain: VAS [ Time Frame: 6 months after the operation ]
    The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints.


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women with chronic pelvic pain for more than 6 months duration
  • women with retroverted retroflexed uterus
  • no response to analgesics
  • fit for laparoscopic surgery

Exclusion Criteria:

  • Women with other causes of pelvic pain as ovarian cysts
  • women with neurological disorders
  • psychologically disturbed,
  • Women with systemic or pelvic infections,
Contacts and Locations
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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): NCT03784872


Contacts
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Contact: Ahmed Maged, MD +201005227404 prof.ahmedmaged@gmail.com
Contact: fadel shaltout, MD +201006023073 dr.shaltout@gmail.com

Locations
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Egypt
Kasr Alainy medical school Recruiting
Cairo, Egypt, 12151
Contact: Ahmed Maged, MD    01005227404    prof.ahmedmaged@gmail.com   
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Maged, MD Professor
More Information
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Responsible Party: Ahmed M Maged, MD, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03784872    
Other Study ID Numbers: 46
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 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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Uterine Retroversion
Pelvic Pain
Pain
Neurologic Manifestations
 Uterine Diseases
Torsion Abnormality
Pathological Conditions, Anatomical