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

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03784872

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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incised followed by introduction of 30 curved needle attached to absorpable Vicryl 2/0 suture through the incision and withdrawn through grasper under laparoscopi vision.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 then the laparoscopy was withdrawn followed by closure of the skin incision.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

Detailed Description

Study Design

Study Type:

Interventional

Anticipated 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 :

Dec 2, 2018

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Outcome Measures

Primary Outcome Measures

Postoperative pain: VAS [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

Criteria

Ages Eligible for Study:

30 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Kasr Alainy medical school	Cairo		Egypt	12151

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Ahmed Maged, MD, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed M Maged, MD, Principal investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT03784872

Other Study ID Numbers:

First Posted:

Dec 24, 2018

Last Update Posted:

Jul 26, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Uterine Retroversion

Pelvic Pain

Study Results

No Results Posted as of Jul 26, 2019