Clinical trial NCT06509425: Pelvic Congestion Syndrome Post Tubal Ligation Versus Salpingectomy Performed During Caesarean Section
Official title: Pelvic Congestion Syndrome Following Salpingectomy Compared to Tubal Ligation at Time of Caesarean Section
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pelvic Congestion Syndrome
Keywords: salpingectomy
pelvic congestion
tubal ligation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 64
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: symptoms of pelvic congestion syndrome
timeFrame: Ten weeks postoperative
Secondary outcomes:
measure: signs of pelvic congestion syndrome
timeFrame: Ten weeks postoperative
measure: intraoperative complications
timeFrame: intraoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity Hospitals
state: Abaseya
Study officials:
References: