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

July 24, 2019 updated by: Ahmed M Maged, MD, Cairo University
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incised followed by introduction of 30 curved needle attached to absorpable Vicryl 2/0 suture through the incision and withdrawn through grasper under laparoscopi vision.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 then the laparoscopy was withdrawn followed by closure of the skin incision.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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incised followed by introduction of 30 curved needle attached to absorpable Vicryl 2/0 suture through the incision and withdrawn through grasper under laparoscopi vision.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 then the laparoscopy was withdrawn followed by closure of the skin incision using Vicryl 2/0 suture.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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 12151
        • Recruiting
        • Kasr Alainy medical school

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2018

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

December 20, 2018

First Submitted That Met QC Criteria

December 21, 2018

First Posted (Actual)

December 24, 2018

Study Record Updates

Last Update Posted (Actual)

July 26, 2019

Last Update Submitted That Met QC Criteria

July 24, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 46

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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