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

Pelvic Congestion Syndrome Following Salpingectomy Compared to Tubal Ligation at Time of Caesarean Section

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

Study Overview

• Status: Recruiting
• Conditions: Pelvic Congestion Syndrome
• Intervention / Treatment: Procedure: salpingectomy during caesarean section; Procedure: tubal ligation during caesarean section

Detailed Description

Women planned for caesarean delivery and tubal sterilization will be screened for eligibility on presenting to the labor unit.

Informed written consent will be taken from all the participants before enrollment in the study.

Randomization will be done at a 1:1 ratio to bilateral salpingectomy or bilateral tubal ligation by a computer-generated scheme. Sequentially numbered sealed opaque envelopes will be prepared, each containing patient allocated procedure. It will be revealed to the case surgeon.

1) Surgical Intervention: Caesarean section and tubal sterilization will be performed by resident on duty.

Identification of the fimbriated end of the Fallopian tube. It will be grasped by a Babcock or Allis forceps.

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.

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.

Hemostasis will be ensured at the incised edges. Participants undergoing salpingectomy will have their fallopian tubes sent for pathological examination to confirm transection and exclude malignancies.

2) Postoperative assessment: Follow up visit after ten weeks.

1. History:

   The participant is asked about these symptoms:

   • Menstrual irregularities
   • Dull, noncyclical throbbing pelvic pain (unilateral or bilateral), worsened with long periods of standing or walking and punctuated by intermittent sharp pain.
2. Sonographic evaluation:

It will be done by the same investigator (Assistant Lecturer at Radiology department, Ain Shams University).

Machine used:

Samsung ultrasound machine with Transvaginal probe 5-7 Megahertz

All participants will be asked to empty their urinary bladder and will be placed in lithotomy position with adequate covering of the participants for transvaginal position. The assessment will detect:

1. Presence of pelvic varicocele. (tortuous and dilated veins that are greater than 6 mm in diameter around the ovary and uterus)
2. Maximal diameter of the pelvic venous plexus.
3. Presence of crossing veins in the myometrium.
4. Change of the duplex waveform during Valsalva's maneuver in both ovarian and internal iliac veins.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mayar Z Kamal; Email: mayarziad2@gmail.com

Study Locations

• Egypt
  • Abaseya
    • Cairo, Abaseya, Egypt, 11588
      • Recruiting
      • Ain Shams Maternity Hospitals
      • Contact: maternity H; Phone Number: 0224346001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Participants undergoing caesarean section and salpingectomy.	Procedure: salpingectomy during caesarean section; 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.
Active Comparator: Participants undergoing caesarean section and tubal ligation	Procedure: tubal ligation during caesarean section; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
symptoms of pelvic congestion syndrome	A questionnaire to detect changes in menstrual pattern or new onset of pelvic pain.	Ten weeks postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
signs of pelvic congestion syndrome	Transvaginal US will be done 10 weeks postoperative for detection of signs of pelvic congestion	Ten weeks postoperative
intraoperative complications	blood transfusion, visceral injury and increased operative time	intraoperative

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: July 13, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 13, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: salpingectomy; tubal ligation; pelvic congestion
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: MS 296/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A case report form for each participant will be shared.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No