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CompletedNCT06267599Updated Feb 20, 2024

Bladder Suture in Uterus-Sparing Surgery and Hysterectomy for Placenta Percreta

An observational study in Placenta Percreta, Bladder Injury and Sutures, sponsored by Necmettin Erbakan University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-02-20.

Sponsored by Necmettin Erbakan University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
81
Ages
18 Years to 50 Years
Sex
Female
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Study 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 hysterectomy.

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Conditions studied

  • Placenta Percreta
  • Bladder Injury
  • Sutures

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Keywords

  • Placenta Percreta, Bladder Invasion, Sutures
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In context

Placenta Accreta

147 studies on the registry are indexed under Placenta Accreta; 39 are open to participants now.

This study's enrollment of 81 is close to the median of 84 across 79 observational studies indexed under Placenta Accreta.

Browse Placenta Accreta studies →

Lead sponsor

Necmettin Erbakan University is the lead sponsor of 198 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • Pregnant women
  • Clinical diagnosis of PAS
  • PAS with bladder invasion

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
81 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    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.

Interventions

  • ProcedureACAR-Style Bladder Suture

    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.

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What researchers measure

Primary outcomes

  1. 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(%).

    Time frame: during operation time

  2. 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)

    Time frame: postoperative three days,

  3. 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.

    Time frame: six months postoperatively

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Study locations

1 site
  • Cemre Alan
    Konya, Turkey
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References and documents

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 37549736 ↗
  • Couret 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 31744356 ↗
  • Committee on Obstetric Practice. Committee opinion no. 529: placenta accreta. Obstet Gynecol. 2012 Jul;120(1):207-11. doi: 10.1097/AOG.0b013e318262e340. PubMed 22914422 ↗
  • Society 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 30471891 ↗
  • Woldu 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 24732915 ↗
  • Erfani 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 34391750 ↗
  • Wu 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 27579379 ↗
  • Li 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 35729022 ↗
  • Acar 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 29989156 ↗
  • Feng 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 35776024 ↗
  • Matsuzaki 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 29194646 ↗
  • Matsubara 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 36448372 ↗
  • Scaglione 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 36201777 ↗
  • Matsubara 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 28875376 ↗
  • Friedrich 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 ↗
  • Crocetto F, Saccone G, Raffone A, Travaglino A, Gragnano E, Bada M, Barone B, Creta M, Zullo F, Imbimbo C. Urinary Incontinence after Planned Cesarean Hysterectomy for Placenta Accreta. Urol Int. 2021;105(11-12):1099-1103. doi: 10.1159/000518114. Epub 2021 Aug 18. PubMed 34515253 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06267599
Lead sponsor
Necmettin Erbakan University
Responsible party
Cemre Alan (Fellow, Necmettin Erbakan University) — Principal investigator
First posted
Feb 20, 2024
Start date
Sep 1, 2023
Primary completion
Dec 1, 2023
Completion
Jan 1, 2024
Last update
Feb 20, 2024

Study contacts

Ali Acar
study director · MD
Şükran Doğru
principal investigator · MD
Fatih Akkuş
study chair · MD
Cemre Alan
study chair · MD
Fikriye Karanfil Yaman
study chair · MD
Huriye Ezveci
study chair · MD
Orhan Ay
study chair · MD
Fethiye Şahin
study chair · MD
Burçin Elaziz
study chair · MD
Meryem Gümüş
study chair · MD

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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