Pelvic Congestion Syndrome Post Tubal Ligation Versus Salpingectomy Performed During Caesarean Section

NCT06509425 | Recruiting DMC

• 1 other identifier: MS 296/2024
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Permanent tubal sterilization during Caesarean section is a reliable method of contraception. It is done either by bilateral tubal ligation or bilateral salpingectomy according to surgeon's preference. Studies revealing bilateral salpingectomy has an added benefit of primary prevention of ovarian cancer has encouraged surgeons to perform bilateral salpingectomy rather than tubal ligation as a risk reducing surgery owing to the acceptance of fallopian tubes as the origin of high grade serous ovarian cancer. Another aspect to take into consideration is the post tubal ligation syndrome as it severely affects the quality of life. Diagnosis is based on clinical picture, imaging, and exclusion of other causes of chronic pelvic pain. Women experience dysmenorrhea, dyspareunia, menstrual irregularities, and pelvic pain. The gold standard is venography; however, the first choice for initial evaluation is duplex ultrasound. In this study, we assess impact of bilateral salpingectomy versus tubal ligation in terms of pelvic congestion by participant's symptoms and ultrasound findings

Conditions

Pelvic Congestion Syndrome

Keywords

salpingectomy; pelvic congestion; tubal ligation

Outcome Measures

Primary Outcomes (1)

• symptoms of pelvic congestion syndrome

  A questionnaire to detect changes in menstrual pattern or new onset of pelvic pain.

  Ten weeks postoperative

Secondary Outcomes (2)

• signs of pelvic congestion syndrome

  Ten weeks postoperative

• intraoperative complications

  intraoperative

Study Arms (2)

Participants undergoing caesarean section and salpingectomy.

ACTIVE COMPARATOR

Procedure: salpingectomy during caesarean section

Participants undergoing caesarean section and tubal ligation

ACTIVE COMPARATOR

Procedure: tubal ligation during caesarean section

Interventions

salpingectomy during caesarean section PROCEDURE

Salpingectomy will be done by clamping, division and ligation using adsorbable suture material (2-0 Vicryl) and excising the tube till it's isthmic part by scissors.

Participants undergoing caesarean section and salpingectomy.

tubal ligation during caesarean section PROCEDURE

Tubal ligation will be done by Parkland technique. An opening is made in an avascular section of the mesosalpinx by electrocautery. Two absorbable suture ties (2-0 Vicryl) are passed through the opening and used to ligate the proximal and distal ends of the segment (at least 2 cm) which will get excised by scissors.

Participants undergoing caesarean section and tubal ligation

Eligibility Criteria

• Age: 30 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females undergoing caesarean section and requesting tubal sterilization as a permanent method of contraception.
• years or older

You may not qualify if:

• Previous history of tubal surgery (changes in blood flow)
• Previous history of oophorectomy (changes in blood flow)
• Congenital anomalies or malformations in fallopian tubes or ovaries. (affection of normal anatomy of pelvic blood vessels)
• Women diagnosed with pelvic congestion. (Known cause for pelvic congestion other than tubal sterilization)
• High likelihood of lost to follow up.
• Inability to provide good data.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams Maternity Hospitals

Cairo, Abaseya, 11588, Egypt

RECRUITING

Central Study Contacts

Mayar Z Kamal

CONTACT

mayarziad2@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: July 19, 2024
• Study Start: May 21, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

EG (1)