Placenta PercretaNCT06267599
Bladder Suture in Uterus-Sparing Surgery and Hysterectomy for Placenta Percreta
An observational study of Placenta Percreta and Bladder Injury, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the short-term and long-term complications of placenta percreta with bladder invasion. This evaluation focuses on cases where bladder dissection and ACAR-style bladder sutures were applied in cases of placenta percreta with bladder invasion that underwent uterine-sparing surgery or… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Placenta Percreta, Bladder Injury, Sutures
- What is being tested?
- ACAR-Style Bladder Suture
- Type of treatment
- Surgery or procedure
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Jan 2024
- Phase
- Observational
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women who underwent surgery for PAS and bladder invasion between January 2018 and January 2023 in a tertiary university hospital in Turkey.
Who may be able to join
- Pregnant women
- Clinical diagnosis of PAS
- PAS with bladder invasion
Who cannot join
- Cases with incomplete or inadequate medical records
- Cases with other types of placental invasion (e.g., placenta accreta, placenta increta),
- Cases with missing key data points.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ACAR-Style Bladder Suture in Uterus-Sparing Surgery and Hysterectomy for Placenta Percreta: A Result Analysis
This study aimed to evaluate the short-term and long-term complications of placenta percreta with bladder invasion. This evaluation focuses on cases where bladder dissection and ACAR-style bladder sutures were applied in cases of placenta percreta with bladder invasion that underwent uterine-sparing surgery or hysterectomy.
- Conditions
- Placenta Percreta, Bladder Injury, Sutures
- Being tested
- ACAR-Style Bladder Suture
- Keywords
- Placenta Percreta, Bladder Invasion, Sutures
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACAR-Style Bladder SutureProcedure or surgery
In cases where dissection is not possible, the upper border of the bladder is opened transversely with a cutter, and the ureteral catheters and trigone inside the bladder are observed. The bladder invasion border is re-evaluated intravesically. The uterine arteries are held bilaterally with a sensitive clamp that does not crush the uterine arteries. Then, the uterus is incised from the upper border of the bladder without damaging the bladder and the predetermined myometrial invasion area is resected. After the placenta is removed, the cervical canal is found and marked with a number one vicryl suture. In these patients, the placental material is removed in pieces in the cervix area where the bladder is invaded. After the removal of the placenta, the cervix in the lower segment of the uterus is orientated and sutured together with the bladder, and this area is closed.
| Study group | Role | What they receive |
|---|---|---|
| Bladder suture group | This group consisted of patients in whom we could not open the bladder and uterine cervix by dissection, so we had to open the bladder. In this group, the bladder dome was opened and a special suture was passed through the bladder to control bleeding. This procedure was performed to control bleeding. Receives: Procedure: ACAR-Style Bladder Suture | |
| Control group | For the patients in this group, the vascular structures between the bladder and cervix were coagulated one by one. The bladder was not opened during this procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of intraoperative bleeding and complication rates of the two groups
It was observed that the amount of intraoperative bleeding (volume aspirated cc blood), surgical time (minutes), blood transfusion rates (%), and hysterectomy rates(%).
Measured: during operation time
Comparison of postoperative bleeding between two groups
It was observed that the amount of postoperative bleeding (hemoglobin(g/dL) change, need for blood transfusion Unite)
Measured: postoperative three days,
Comparison of complication rate between two groups
It was described as long-term bladder dysfunction(Nocturia, Urgency, Stress urinary incontinance, fistula rate (%))
Nocturia: Waking up more than once during the night. Urgency: Sudden, intense urge to urinate followed by an involuntary loss of urine.
Stress urinary incontinance: Happens when physical movement or activity - such as coughing, laughing, sneezing, running or heavy lifting - puts pressure (stress) on your bladder, causing you to leak urine.
Measured: six months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Sep 2023
- Primary completion1 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Placenta PercretaStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cemre Alan, Necmettin Erbakan University
- Investigators
- Ali Acar, Study director, MDŞükran Doğru, Principal investigator, MDFatih Akkuş, Study chair, MDCemre Alan, Study chair, MDFikriye Karanfil Yaman, Study chair, MDHuriye Ezveci, Study chair, MDOrhan Ay, Study chair, MDFethiye Şahin, Study chair, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267599
- Sponsor's protocol ID
- ACAR-Style Bladder Suture
- Status last verified
- Feb 2024
- First submitted
- 15 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Horgan R, Hessami K, Hage Diab Y, Scaglione M, D'Antonio F, Kanaan C, Erfani H, Abuhamad A, Shamshirsaz AA. Prophylactic ureteral stent placement for the prevention of genitourinary tract injury during hysterectomy for placenta accreta spectrum: systematic review and meta-analysis. Am J Obstet Gynecol MFM. 2023 Oct;5(10):101120. doi: 10.1016/j.ajogmf.2023.101120. Epub 2023 Aug 5.
PubMed 37549736Couret M, Huang Y, Khoury-Collado F, Friedman A, Hou JY, St Clair CM, Tergas AI, Ananth CV, Wright JD. Patterns of care for women with placenta accreta spectrum. J Matern Fetal Neonatal Med. 2021 Oct;34(20):3370-3376. doi: 10.1080/14767058.2019.1684471. Epub 2019 Nov 19.
PubMed 31744356Committee on Obstetric Practice. Committee opinion no. 529: placenta accreta. Obstet Gynecol. 2012 Jul;120(1):207-11. doi: 10.1097/AOG.0b013e318262e340.
PubMed 22914422Society of Gynecologic Oncology; American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine; Cahill AG, Beigi R, Heine RP, Silver RM, Wax JR. Placenta Accreta Spectrum. Am J Obstet Gynecol. 2018 Dec;219(6):B2-B16. doi: 10.1016/j.ajog.2018.09.042.
PubMed 30471891Woldu SL, Ordonez MA, Devine PC, Wright JD. Urologic considerations of placenta accreta: a contemporary tertiary care institutional experience. Urol Int. 2014;93(1):74-9. doi: 10.1159/000356064. Epub 2014 Apr 9.
PubMed 24732915Erfani H, Salmanian B, Fox KA, Coburn M, Meshinchiasl N, Shamshirsaz AA, Kopkin R, Gogia S, Patel K, Jackson J, Cadena M, Aalipour S, Sukumar S, Nassr AA, Espinoza J, Clark SL, Belfort MA, Shamshirsaz AA. Urologic morbidity associated with placenta accreta spectrum surgeries: single-center experience with a multidisciplinary team. Am J Obstet Gynecol. 2022 Feb;226(2):245.e1-245.e5. doi: 10.1016/j.ajog.2021.08.010. Epub 2021 Aug 13.
PubMed 34391750Wu WJ, Smith AD, Okeke Z. Bladder Necrosis Associated with Placenta Accreta, Embolization, and Repair of Cystotomies. J Endourol Case Rep. 2015 Oct 1;1(1):24-6. doi: 10.1089/cren.2015.29007.wjw. eCollection 2015.
PubMed 27579379Li GT, Li XF, Ding Y. Cervicovesical U-suture: An effective novel alternative to partial cystectomy for controlling life-threatening postpartum hemorrhage due to placenta accreta spectrum invading the bladder. Asian J Surg. 2022 Dec;45(12):2745-2747. doi: 10.1016/j.asjsur.2022.06.018. Epub 2022 Jun 18. No abstract available.
PubMed 35729022Acar A, Ercan F, Pekin A, Elci Atilgan A, Sayal HB, Balci O, Gorkemli H. Conservative management of placental invasion anomalies with an intracavitary suture technique. Int J Gynaecol Obstet. 2018 Nov;143(2):184-190. doi: 10.1002/ijgo.12593. Epub 2018 Aug 13.
PubMed 29989156Feng JP, Fan DZ, Lin DX, Zhang HS, Rao JM, Liu ZP. Sandwich excision in patients with placenta percreta involving maternal bladder. Eur Rev Med Pharmacol Sci. 2022 Jun;26(12):4252-4257. doi: 10.26355/eurrev_202206_29062.
PubMed 35776024Matsuzaki S, Yoshino K, Endo M, Kakigano A, Takiuchi T, Kimura T. Conservative management of placenta percreta. Int J Gynaecol Obstet. 2018 Mar;140(3):299-306. doi: 10.1002/ijgo.12411. Epub 2018 Jan 3.
PubMed 29194646Matsubara S. Intentional cystotomy in surgery for placenta percreta with bladder invasion: Not only for hysterectomy but also for uterus-preserving surgery. Acta Obstet Gynecol Scand. 2023 Jan;102(1):122-123. doi: 10.1111/aogs.14484. Epub 2022 Nov 30. No abstract available.
PubMed 36448372Scaglione MA, Allshouse AA, Canfield DR, Mclaughlin HD, Bruno AM, Hammad IA, Branch DW, Maurer KA, Dood RL, Debbink MP, Silver RM, Einerson BD. Prophylactic Ureteral Stent Placement and Urinary Injury During Hysterectomy for Placenta Accreta Spectrum. Obstet Gynecol. 2022 Nov 1;140(5):806-811. doi: 10.1097/AOG.0000000000004957. Epub 2022 Oct 5.
PubMed 36201777Matsubara S, Takahashi H, Baba Y. Handling aberrant vessels located in the posterior bladder wall in surgery for abnormally invasive placenta: a non/less-touch technique. Arch Gynecol Obstet. 2017 Nov;296(5):851-853. doi: 10.1007/s00404-017-4498-2. Epub 2017 Sep 5.
PubMed 28875376Friedrich L, Mor N, Weissmann-Brenner A, Kassif E, Friedrich SN, Weissbach T, Castel E, Levin G, Meyer R. Risk factors for bladder injury during placenta accreta spectrum surgery. Int J Gynaecol Obstet. 2023 Jun;161(3):911-919. doi: 10.1002/ijgo.14567. Epub 2022 Nov 28.
PubMed 36353748
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACAR-Style Bladder Suture in Uterus-Sparing Surgery and Hysterectomy for Placenta Percreta: A Result Analysis
- ClinicalTrials.gov ID
- NCT06267599
- Acronym / sponsor ID
- ACAR-Style Bladder Suture
- Conditions
- Placenta Percreta, Bladder Injury, Sutures
- Keywords
- Placenta Percreta, Bladder Invasion, Sutures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 20 Feb 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.
This study aimed to evaluate the short-term and long-term complications of placenta percreta with bladder invasion. This evaluation focuses on cases where bladder dissection and ACAR-style bladder sutures were applied in cases of placenta percreta with bladder invasion that underwent uterine-sparing surgery or hysterectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bladder suture group | – | Procedure: ACAR-Style Bladder SutureThis group consisted of patients in whom we could not open the bladder and uterine cervix by dissection, so we had to open the bladder. In this group, the bladder dome was opened and a special suture was passed through the bladder to control bleeding. This procedure was performed to control bleeding. |
| Control group | – | –For the patients in this group, the vascular structures between the bladder and cervix were coagulated one by one. The bladder was not opened during this procedure. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women who underwent surgery for PAS and bladder invasion between January 2018 and January 2023 in a tertiary university hospital in Turkey.
Key inclusion criteria (3 listed)
- Pregnant women
- Clinical diagnosis of PAS
- PAS with bladder invasion
Key exclusion criteria (3 listed)
- Cases with incomplete or inadequate medical records
- Cases with other types of placental invasion (e.g., placenta accreta, placenta increta),
- Cases with missing key data points.
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 |
|---|---|---|
| ACAR-Style Bladder SutureIn cases where dissection is not possible, the upper border of the bladder is opened transversely with a cutter, and the ureteral catheters and trigone inside the bladder are observed. The bladder invasion border is re-evaluated intravesically. The uterine arteries are held bilaterally with a sensitive clamp that does not crush the uterine arteries. Then, the uterus is incised from the upper border of the bladder without damaging the bladder and the predetermined myometrial invasion area is resected. After the placenta is removed, the cervical canal is found and marked with a number one vicryl suture. In these patients, the placental material is removed in pieces in the cervix area where the bladder is invaded. After the removal of the placenta, the cervix in the lower segment of the uterus is orientated and sutured together with the bladder, and this area is closed. | Procedure or surgery | Bladder suture group |
Primary outcome
Comparison of intraoperative bleeding and complication rates of the two groups
Time frame: during operation time
It was observed that the amount of intraoperative bleeding (volume aspirated cc blood), surgical time (minutes), blood transfusion rates (%), and hysterectomy rates(%).
Comparison of postoperative bleeding between two groups
Time frame: postoperative three days,
It was observed that the amount of postoperative bleeding (hemoglobin(g/dL) change, need for blood transfusion Unite)
Comparison of complication rate between two groups
Time frame: six months postoperatively
It was described as long-term bladder dysfunction(Nocturia, Urgency, Stress urinary incontinance, fistula rate (%)) Nocturia: Waking up more than once during the night. Urgency: Sudden, intense urge to urinate followed by an involuntary loss of urine. Stress urinary incontinance: Happens when physical movement or activity - such as coughing, laughing, sneezing, running or heavy lifting - puts pressure (stress) on your bladder, causing you to leak urine.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 37549736Horgan R, Hessami K, Hage Diab Y, Scaglione M, D'Antonio F, Kanaan C, Erfani H, Abuhamad A, Shamshirsaz AA. Prophylactic ureteral stent placement for the prevention of genitourinary tract injury during hysterectomy for placenta accreta spectrum: systematic review and meta-analysis. Am J Obstet Gynecol MFM. 2023 Oct;5(10):101120. doi: 10.1016/j.ajogmf.2023.101120. Epub 2023 Aug 5.
- Background: PubMed 31744356Couret M, Huang Y, Khoury-Collado F, Friedman A, Hou JY, St Clair CM, Tergas AI, Ananth CV, Wright JD. Patterns of care for women with placenta accreta spectrum. J Matern Fetal Neonatal Med. 2021 Oct;34(20):3370-3376. doi: 10.1080/14767058.2019.1684471. Epub 2019 Nov 19.
- Background: PubMed 22914422Committee on Obstetric Practice. Committee opinion no. 529: placenta accreta. Obstet Gynecol. 2012 Jul;120(1):207-11. doi: 10.1097/AOG.0b013e318262e340.
- Background: PubMed 30471891Society of Gynecologic Oncology; American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine; Cahill AG, Beigi R, Heine RP, Silver RM, Wax JR. Placenta Accreta Spectrum. Am J Obstet Gynecol. 2018 Dec;219(6):B2-B16. doi: 10.1016/j.ajog.2018.09.042.
- Background: PubMed 24732915Woldu SL, Ordonez MA, Devine PC, Wright JD. Urologic considerations of placenta accreta: a contemporary tertiary care institutional experience. Urol Int. 2014;93(1):74-9. doi: 10.1159/000356064. Epub 2014 Apr 9.
- Background: PubMed 34391750Erfani H, Salmanian B, Fox KA, Coburn M, Meshinchiasl N, Shamshirsaz AA, Kopkin R, Gogia S, Patel K, Jackson J, Cadena M, Aalipour S, Sukumar S, Nassr AA, Espinoza J, Clark SL, Belfort MA, Shamshirsaz AA. Urologic morbidity associated with placenta accreta spectrum surgeries: single-center experience with a multidisciplinary team. Am J Obstet Gynecol. 2022 Feb;226(2):245.e1-245.e5. doi: 10.1016/j.ajog.2021.08.010. Epub 2021 Aug 13.
- Background: PubMed 27579379Wu WJ, Smith AD, Okeke Z. Bladder Necrosis Associated with Placenta Accreta, Embolization, and Repair of Cystotomies. J Endourol Case Rep. 2015 Oct 1;1(1):24-6. doi: 10.1089/cren.2015.29007.wjw. eCollection 2015.
- Background: PubMed 35729022Li GT, Li XF, Ding Y. Cervicovesical U-suture: An effective novel alternative to partial cystectomy for controlling life-threatening postpartum hemorrhage due to placenta accreta spectrum invading the bladder. Asian J Surg. 2022 Dec;45(12):2745-2747. doi: 10.1016/j.asjsur.2022.06.018. Epub 2022 Jun 18. No abstract available.
- Background: PubMed 29989156Acar A, Ercan F, Pekin A, Elci Atilgan A, Sayal HB, Balci O, Gorkemli H. Conservative management of placental invasion anomalies with an intracavitary suture technique. Int J Gynaecol Obstet. 2018 Nov;143(2):184-190. doi: 10.1002/ijgo.12593. Epub 2018 Aug 13.
- Background: PubMed 35776024Feng JP, Fan DZ, Lin DX, Zhang HS, Rao JM, Liu ZP. Sandwich excision in patients with placenta percreta involving maternal bladder. Eur Rev Med Pharmacol Sci. 2022 Jun;26(12):4252-4257. doi: 10.26355/eurrev_202206_29062.
- Background: PubMed 29194646Matsuzaki S, Yoshino K, Endo M, Kakigano A, Takiuchi T, Kimura T. Conservative management of placenta percreta. Int J Gynaecol Obstet. 2018 Mar;140(3):299-306. doi: 10.1002/ijgo.12411. Epub 2018 Jan 3.
- Background: PubMed 36448372Matsubara S. Intentional cystotomy in surgery for placenta percreta with bladder invasion: Not only for hysterectomy but also for uterus-preserving surgery. Acta Obstet Gynecol Scand. 2023 Jan;102(1):122-123. doi: 10.1111/aogs.14484. Epub 2022 Nov 30. No abstract available.
- Dogru S, Akkus F, Atci AA et al. (2022) The fetal and maternal outcomes related to previous number of cesarean sections and uterus sparing surgery in women with abnormal placentation. Journal of Clinical and Investigative Surgery 7:29-30.Link provided by the sponsor.
- Doğru Ş, Altınordu Atcı A, Akkuş F et al. (2022) Use of ureteral catheter in uterine-sparing surgery for placenta accreta. Perinatal Journal 30:158-164.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Placenta Accreta / Percreta
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.
Ali Acar study director
MD
Şükran Doğru principal investigator
MD
Fatih Akkuş study chair
MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Percreta and Bladder Injury, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 20 Feb 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of intraoperative bleeding and complication rates of the two groups (time frame: during operation time). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06267599, which also lists 16 linked publications.
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 20 Feb 2024.