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

NCT03784872 | Unknown DMC

• 1 other identifier: 46
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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incised followed by introduction of 30 curved needle attached to absorpable Vicryl 2/0 suture through the incision and withdrawn through grasper under laparoscopi vision.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 then the laparoscopy was withdrawn followed by closure of the skin incision.

Conditions

Chronic Pelvic Pain

Outcome Measures

Primary Outcomes (1)

• Postoperative pain: VAS

  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

Interventions

Laparoscopic guided Ventrosuspension PROCEDURE

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incised followed by introduction of 30 curved needle attached to absorpable Vicryl 2/0 suture through the incision and withdrawn through grasper under laparoscopi vision.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 then the laparoscopy was withdrawn followed by closure of the skin incision.

Eligibility Criteria

• Age: 30 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Women with other causes of pelvic pain as ovarian cysts
• women with neurological disorders
• psychologically disturbed,
• Women with systemic or pelvic infections,

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

RECRUITING

Study Officials

• Ahmed Maged, MD

  Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

+201005227404; prof.ahmedmaged@gmail.com

fadel shaltout, MD

CONTACT

+201006023073; dr.shaltout@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 24, 2018
• Study Start: December 2, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 26, 2019

Record last verified: 2019-07

Locations

EG (1)