An interventional study of salpingectomy during caesarean section and tubal ligation during caesarean section in Pelvic Congestion Syndrome, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to female participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-19.
Sponsored by Ain Shams University · Not applicable, Interventional, and Prevention
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
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.
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.
History:
The participant is asked about these symptoms:
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:
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Exclusion Criteria:
Procedure: salpingectomy during caesarean section
Procedure: tubal ligation 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.
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.
symptoms of pelvic congestion syndrome
A questionnaire to detect changes in menstrual pattern or new onset of pelvic pain.
Time frame: Ten weeks postoperative
signs of pelvic congestion syndrome
Transvaginal US will be done 10 weeks postoperative for detection of signs of pelvic congestion
Time frame: Ten weeks postoperative
intraoperative complications
blood transfusion, visceral injury and increased operative time
Time frame: intraoperative
Plan to share: Yes — A case report form for each participant will be shared.
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
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Ain Shams University