Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06509425
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-04-23
Brief Title:
Pelvic Congestion Syndrome Post Tubal Ligation Versus Salpingectomy Performed During Caesarean Section
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pelvic Congestion Syndrome Following Salpingectomy Compared to Tubal Ligation at Time of Caesarean Section
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 surgeons 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 participants symptoms and ultrasound findings
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 participants 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 11 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 its 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 Valsalvas maneuver in both ovarian and internal iliac veins
Informed written consent will be taken from all the participants before enrollment in the study
Randomization will be done at a 11 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 its 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 Valsalvas maneuver in both ovarian and internal iliac veins
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None