Pelvic Congestion SyndromeNCT06509425
Pelvic Congestion Syndrome Post Tubal Ligation Versus Salpingectomy Performed During Caesarean Section
A study testing salpingectomy during caesarean section and tubal ligation during caesarean section in people with Pelvic Congestion Syndrome, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Congestion Syndrome
- What is being tested?
- salpingectomy during caesarean section and tubal ligation during caesarean section
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 21 May 2024to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females undergoing caesarean section and requesting tubal sterilization as a permanent method of contraception.
- 30 years or older
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mayar Z Kamal contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams Maternity Hospitals
Cairo, Abaseya, 11588
maternity H, 0224346001
About this study
Official title: 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.
Read more
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
Read the 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.
- 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.
- Postoperative assessment: Follow up visit after ten weeks.
- 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.
- 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:
- Presence of pelvic varicocele. (tortuous and dilated veins that are greater than 6 mm in diameter around the ovary and uterus)
- Maximal diameter of the pelvic venous plexus.
- Presence of crossing veins in the myometrium.
- Change of the duplex waveform during Valsalva's maneuver in both ovarian and internal iliac veins.
- Conditions
- Pelvic Congestion Syndrome
- Being tested
- salpingectomy during caesarean section, tubal ligation during caesarean section
- Keywords
- salpingectomy, pelvic congestion, tubal ligation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salpingectomy during caesarean sectionProcedure or surgery
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 during caesarean sectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants undergoing caesarean section and salpingectomy. | Active comparator | Not described Receives: Procedure: salpingectomy during caesarean section |
| Participants undergoing caesarean section and tubal ligation | Active comparator | Not described Receives: Procedure: tubal ligation during caesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptoms of pelvic congestion syndrome
A questionnaire to detect changes in menstrual pattern or new onset of pelvic pain.
Measured: Ten weeks postoperative
Secondary outcomes (2)
signs of pelvic congestion syndrome
Transvaginal US will be done 10 weeks postoperative for detection of signs of pelvic congestion
Measured: Ten weeks postoperative
intraoperative complications
blood transfusion, visceral injury and increased operative time
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start21 May 2024
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Congestion SyndromeStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509425
- Sponsor's protocol ID
- MS 296/2024
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A case report form for each participant will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Congestion Syndrome Following Salpingectomy Compared to Tubal Ligation at Time of Caesarean Section
- ClinicalTrials.gov ID
- NCT06509425
- Acronym / sponsor ID
- MS 296/2024
- Conditions
- Pelvic Congestion Syndrome
- Keywords
- salpingectomy, pelvic congestion, tubal ligation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 21 May 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- Postoperative assessment: Follow up visit after ten weeks.
- 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.
- 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:
- Presence of pelvic varicocele. (tortuous and dilated veins that are greater than 6 mm in diameter around the ovary and uterus)
- Maximal diameter of the pelvic venous plexus.
- Presence of crossing veins in the myometrium.
- Change of the duplex waveform during Valsalva's maneuver in both ovarian and internal iliac veins.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Females undergoing caesarean section and requesting tubal sterilization as a permanent method of contraception.
- 30 years or older
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| salpingectomy during caesarean sectionSalpingectomy 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. | Procedure or surgery | Participants undergoing caesarean section and salpingectomy. |
| tubal ligation during caesarean sectionTubal 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. | Procedure or surgery | Participants undergoing caesarean section and tubal ligation |
Primary outcome
symptoms of pelvic congestion syndrome
Time frame: Ten weeks postoperative
A questionnaire to detect changes in menstrual pattern or new onset of pelvic pain.
2 secondary outcomes
signs of pelvic congestion syndrome
Time frame: Ten weeks postoperative
intraoperative complications
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Individual participant dataSharing planned: Yes. A case report form for each participant will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mayar Z Kamal contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing salpingectomy during caesarean section and tubal ligation during caesarean section in people with Pelvic Congestion Syndrome, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mayar Z Kamal (mayarziad2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptoms of pelvic congestion syndrome (time frame: Ten weeks postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.