Apical ProlapsePhase 4NCT04002375
Posterior Approach for Pectouteropexy
A Phase 4 study testing pectouteropexy in people with Apical Prolapse, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital.
Trial summary
Pectouteropexy surgery has lower complication rates compared to other sling operations. Sacrocolpopexy is another common procedure for hanging the uterus. Small bowel obstruction, ileus or defecation problems are observed in percentages ranging from 0.1 to 5%. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Apical Prolapse
- What is being tested?
- pectouteropexy
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2019to 27 Feb 2020
- Phase
- Phase 4
- 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 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1. Being between 30-60 years of age 2. To be diagnosed with at least Stage 2 apical prolapse 3. To have completed fertility 4. To be treated with pectouteropexy for the prolapse
Who cannot join
- 1. Having had previous prolapse surgery 2. To have connective tissue diseases 3. Inable to cooperate
Trial locations and contacts
No sites are listed yet.
About this study
Pectouteropexy surgery has lower complication rates compared to other sling operations. Sacrocolpopexy is another common procedure for hanging the uterus. Small bowel obstruction, ileus or defecation problems are observed in percentages ranging from 0.1 to 5%. Mesh placed between sacrum and vagina often causes narrowing of the pelvis, adhesions may occur and traumas may occur in hypogastic nerves. However, presacral bleeding, which is the most feared complication of these operations, is a rare but life-threatening condition. In pectouteropexy, it is located away from the bladder, intestine and hypogastric vessels by placing the iliopectineal ligament laterally and eliminates the risk of presacral hemorrhage.
In pectouteropexy surgery, the mesh is placed anterior to the cervix. The points emphasized in the criticisms about this technique, inadequate support of the posterior compartment mesh placed in anterior in a future pregnancy is a possible cesarean section and the negative effects on the delivery process.
Therefore, a new technique of pectouteropexy surgery to the posterior of the cervix instead of the anterior cervix of the cervix, the sacrouterine ligament to reduce the complications that may occur due to this procedure and this study was planned to increase the effectiveness.
Read the detailed description
The study was planned prospectively. The research is planned to be conducted between 30.06.2019 and 30.12.2019. Study Kartal İstanbul Prof. Dr. Lütfi Kırdar Training and Research Hospital Department of Obstetrics and Gynecology. Under the responsibility of Prof. Dr. Ahmet Kale, it will be conducted by Kazibe Koyuncu. The study was planned as a pilot study since it was planned to investigate the results of performing the surgical method with the posterior approach instead of the anterior approach and it was calculated that the inclusion of 20 patients would be sufficient. It is planned to include 20 patients between 30-60 years of age who applied to hospital with prolapse complaint and completed fertility request. Patients' symptoms and physical examinations will be recorded in accordance with international standards and questionnaires will be applied to the files in order to make objective evaluation before and after surgery. Pre-and post-operative POP-Q classifications will be recorded in the files, PFDI-20 questionnaire evaluating the severity of prolapse before and after the surgery, and PGI questionnaire evaluating postoperative satisfaction. In the pectouteropexy operation we applied to the patients, the support of the uterus posterior was insufficient in the sling fixation with mesh suture to the anterior and iliopectineal ligaments of the uterine cervix. We aimed to increase the efficiency of the operation by hanging the uterine cervix posterolaterale to the iliopectineal ligament with the anterior uterine cervix in order to get better results with this method, which can be applied more safely and easily than the other sling methods. Consent form is attached.
There are validity-reliability studies of the questionnaires to be used in Turkish.
- Conditions
- Apical Prolapse
- Being tested
- pectouteropexy
- Keywords
- pectouteropexy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pectouteropexyOther
The surgical procedure was initiated after adhesiolysis had been performed by opening the peritoneal layer along the round ligament toward the pelvic side wall. Preparation started at the right external iliac vein and was performed in the medial and caudal direction. A segment of area approximately 3- 4 cm2 of the right lateral part of the iliopectineal ligament (Cooper ligament) adjacent to the insertion of the iliopsoas muscle was exposed.The peritoneum of the bladder was dissected, and the anterior parts of the distal uterus were prepared for mesh fixation. The uterus was elevated to the intended tension-free position using the transvaginal probe (POP-Q level 0-1). The mesh was fixed anteriorly to the cervix using four polyester permanent sutures (Ethibond Excel®; Ethicon). Finally, the mesh was covered with peritoneum using a continuous monofilament absorbable suture (Maxon™; Medtronic).
What is being measured
The primary outcome is the main question the study is designed to answer.
POP-Q assesment
pelvic organ prolapse quantification system assessment, does not have any maximum or minimum value, it is scored according to the visualization and is used to assess the difference of prolapse objectively
Measured: postoperative 1. day
Secondary outcomes (2)
operation satisfaction
operation satisfaction will be assessed via patient global impression of improvement, it is scaled one to seven, one is related to be satisfied with the result of operation and seven is related to not satisfied from the operation results
Measured: postoperative 1month
pain scores
pain scores will be assessed via visual analog scale questionnaire, it is scaled one to ten, one is related to have a little pain and 10 is related to have a lot of pain
Measured: postoperative 1. day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start30 Jun 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion27 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical ProlapseStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kazibe Koyuncu, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002375
- Sponsor's protocol ID
- KK201906
- Status last verified
- Jun 2019
- First submitted
- 25 Jun 2019
- Last updated
- 28 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Approach for Pectouteropexy
- ClinicalTrials.gov ID
- NCT04002375
- Acronym / sponsor ID
- KK201906
- Conditions
- Apical Prolapse
- Keywords
- pectouteropexy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 30 Jun 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 27 Feb 2020 (estimated)
- First posted
- 28 Jun 2019 (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.
Pectouteropexy surgery has lower complication rates compared to other sling operations. Sacrocolpopexy is another common procedure for hanging the uterus. Small bowel obstruction, ileus or defecation problems are observed in percentages ranging from 0.1 to 5%. Mesh placed between sacrum and vagina often causes narrowing of the pelvis, adhesions may occur and traumas may occur in hypogastic nerves. However, presacral bleeding, which is the most feared complication of these operations, is a rare but life-threatening condition. In pectouteropexy, it is located away from the bladder, intestine and hypogastric vessels by placing the iliopectineal ligament laterally and eliminates the risk of presacral hemorrhage.
In pectouteropexy surgery, the mesh is placed anterior to the cervix. The points emphasized in the criticisms about this technique, inadequate support of the posterior compartment mesh placed in anterior in a future pregnancy is a possible cesarean section and the negative effects on the delivery process.
Therefore, a new technique of pectouteropexy surgery to the posterior of the cervix instead of the anterior cervix of the cervix, the sacrouterine ligament to reduce the complications that may occur due to this procedure and this study was planned to increase the effectiveness.
Detailed description
The study was planned prospectively. The research is planned to be conducted between 30.06.2019 and 30.12.2019. Study Kartal İstanbul Prof. Dr. Lütfi Kırdar Training and Research Hospital Department of Obstetrics and Gynecology. Under the responsibility of Prof. Dr. Ahmet Kale, it will be conducted by Kazibe Koyuncu. The study was planned as a pilot study since it was planned to investigate the results of performing the surgical method with the posterior approach instead of the anterior approach and it was calculated that the inclusion of 20 patients would be sufficient. It is planned to include 20 patients between 30-60 years of age who applied to hospital with prolapse complaint and completed fertility request. Patients' symptoms and physical examinations will be recorded in accordance with international standards and questionnaires will be applied to the files in order to make objective evaluation before and after surgery. Pre-and post-operative POP-Q classifications will be recorded in the files, PFDI-20 questionnaire evaluating the severity of prolapse before and after the surgery, and PGI questionnaire evaluating postoperative satisfaction. In the pectouteropexy operation we applied to the patients, the support of the uterus posterior was insufficient in the sling fixation with mesh suture to the anterior and iliopectineal ligaments of the uterine cervix. We aimed to increase the efficiency of the operation by hanging the uterine cervix posterolaterale to the iliopectineal ligament with the anterior uterine cervix in order to get better results with this method, which can be applied more safely and easily than the other sling methods. Consent form is attached.
There are validity-reliability studies of the questionnaires to be used in Turkish.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Being between 30-60 years of age 2. To be diagnosed with at least Stage 2 apical prolapse 3. To have completed fertility 4. To be treated with pectouteropexy for the prolapse
Key exclusion criteria (1 listed)
- 1. Having had previous prolapse surgery 2. To have connective tissue diseases 3. Inable to cooperate
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 |
|---|---|---|
| pectouteropexyThe surgical procedure was initiated after adhesiolysis had been performed by opening the peritoneal layer along the round ligament toward the pelvic side wall. Preparation started at the right external iliac vein and was performed in the medial and caudal direction. A segment of area approximately 3- 4 cm2 of the right lateral part of the iliopectineal ligament (Cooper ligament) adjacent to the insertion of the iliopsoas muscle was exposed.The peritoneum of the bladder was dissected, and the anterior parts of the distal uterus were prepared for mesh fixation. The uterus was elevated to the intended tension-free position using the transvaginal probe (POP-Q level 0-1). The mesh was fixed anteriorly to the cervix using four polyester permanent sutures (Ethibond Excel®; Ethicon). Finally, the mesh was covered with peritoneum using a continuous monofilament absorbable suture (Maxon™; Medtronic). | Other | – |
Primary outcome
POP-Q assesment
Time frame: postoperative 1. day
pelvic organ prolapse quantification system assessment, does not have any maximum or minimum value, it is scored according to the visualization and is used to assess the difference of prolapse objectively
2 secondary outcomes
operation satisfaction
Time frame: postoperative 1month
pain scores
Time frame: postoperative 1. day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Apical Prolapse
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Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
Visceral Prolapse
Recruiting
Comparison of the Effectiveness and Learning Curve of Laparoscopic Pectopexy Versus Laparoscopic Sacrocolpopexy
Apical Prolapse
Active, not recruitingObservational study
To Explore the Surgical Outcomes and Safety of an Innovative Laparoscopic Uterine Pectopexy Technique Using Inverted T-meshes for Simultaneous Apical and Anterior Vaginal Repair.
Pelvic Organ Prolapse, Pelvic Organ Prolapse Vaginal Surgery
Recruiting
Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Prolapse - Prospective Randomized Non-inferiority Study
Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pectouteropexy in people with Apical Prolapse, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital.
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 1 inclusion and 1 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 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 kazibe koyuncu, M.D. (00905053728124, kazibekkoyuncu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POP-Q assesment (time frame: postoperative 1. day). 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 28 Jun 2019.