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

NCT06267599 | Completed

• 1 other identifier: ACAR-Style Bladder Suture
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Placenta Percreta; Bladder Injury; Sutures

Keywords

Placenta Percreta, Bladder Invasion, Sutures

Outcome Measures

Primary Outcomes (3)

• 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(%).

  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)

  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.

  six months postoperatively

Study Arms (2)

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

ACAR-Style Bladder Suture PROCEDURE

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.

Bladder suture group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Cemre Alan

Konya, Turkey (Türkiye)

Location

Related Publications (16)

• 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.

  PMID: 37549736 BACKGROUND

• 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.

  PMID: 31744356 BACKGROUND

• Committee on Obstetric Practice. Committee opinion no. 529: placenta accreta. Obstet Gynecol. 2012 Jul;120(1):207-11. doi: 10.1097/AOG.0b013e318262e340.

  PMID: 22914422 BACKGROUND

• 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.

  PMID: 30471891 BACKGROUND

• 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.

  PMID: 24732915 BACKGROUND

• 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.

  PMID: 34391750 BACKGROUND

• 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.

  PMID: 27579379 BACKGROUND

• 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.

  PMID: 35729022 BACKGROUND

• 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.

  PMID: 29989156 BACKGROUND

• 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.

  PMID: 35776024 BACKGROUND

• 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.

  PMID: 29194646 BACKGROUND

• 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.

  PMID: 36448372 BACKGROUND

• 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.

  PMID: 36201777 BACKGROUND

• 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.

  PMID: 28875376 BACKGROUND

• 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.

  PMID: 36353748 BACKGROUND

• 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.

  PMID: 34515253 BACKGROUND

Related Links

• 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.
• 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.

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Officials

• Ali Acar

  MD

  STUDY DIRECTOR

• Şükran Doğru

  MD

  PRINCIPAL INVESTIGATOR

• Fatih Akkuş

  MD

  STUDY CHAIR

• Cemre Alan

  MD

  STUDY CHAIR

• Fikriye Karanfil Yaman

  MD

  STUDY CHAIR

• Huriye Ezveci

  MD

  STUDY CHAIR

• Orhan Ay

  MD

  STUDY CHAIR

• Fethiye Şahin

  MD

  STUDY CHAIR

• Burçin Elaziz

  MD

  STUDY CHAIR

• Meryem Gümüş

  MD

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 20, 2024
• Study Start: September 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

TU (1)