Intraperitoneal Saline Irrigation in Cesarean Section

Официальное название

Intraperitoneal Saline Irrigation in Cesarean Section: Effect on Postoperative Infectious Morbidity and Paralytic Ileus ,Randomized Controlled Study.

Обзор

The study evaluates the effect of intraperitoneal saline irrigation before abdominal closure during cesarean section on postoperative infectious morbidity and the incidence of paralytic ileus.

Подробное описание

Cesarean section is one of the most commonly performed surgical procedures worldwide. Despite advances in surgical techniques, aseptic measures, and perioperative antibiotic prophylaxis, postoperative complications such as infectious morbidity and paralytic ileus remain significant causes of maternal morbidity, prolonged hospital stay, and increased healthcare costs. Postoperative infectious morbidity may include endometritis, wound infection, pelvic abscess, and febrile morbidity, while paralytic ileus may delay recovery, ambulation, and initiation of oral feeding.

Intraperitoneal saline irrigation has been proposed as a simple and inexpensive intraoperative technique that may reduce postoperative complications. Irrigation may help remove blood clots, tissue debris, vernix caseosa, and bacterial contaminants from the peritoneal cavity, thereby decreasing inflammatory response and the risk of postoperative infection. In addition, reducing intra-abdominal irritation may improve bowel motility and decrease the incidence of postoperative paralytic ileus.

However, the effectiveness of intraperitoneal saline irrigation during cesarean section remains controversial. Some studies have suggested potential benefits in reducing postoperative febrile morbidity and improving recovery, while others reported no significant advantage. Due to the limited and conflicting evidence, further randomized controlled studies are needed to evaluate the role of intraperitoneal saline irrigation in cesarean delivery.

Therefore, this study aims to assess the effect of intraperitoneal saline irrigation in cesarean section on postoperative infectious morbidity and paralytic ileus.

Вмешательства

• Процедура Intraperitoneal Saline Irrigation
  Intraperitoneal irrigation with 1000 mL of warm sterile 0.9% normal saline during cesarean section, followed by complete aspiration before abdominal closure.

Первичные конечные точки

• Postoperative infectious morbidity within 6 weeks [Срок оценки: 6 Week]
• Paralytic ileus [Срок оценки: baseline]

Вторичные конечные точки (2)

• Length of hospital stay in days [Срок оценки: 6 week]
• Readmission rate within 6 weeks [Срок оценки: 6 week]

Критерии участия

Критерии включения

• Age 18-40 years
• Elective CS at term ≥37 weeks
• Singleton pregnancy
• Intact membranes
• BMI 18.5 - 34.9 kg/m²

Критерии исключения

• Chorioamnionitis or intrauterine infection
• Prolonged rupture of membranes > 18 hours
• History of previous abdominal surgery other than CS
• Immunocompromised patients or on corticosteroids
• Severe anemia Hb < 8 g/dL
• Diabetes mellitus or hypertension
• Placenta previa or accreta spectrum disorders
• Emergency CS for uterine rupture or severe bleeding
• Known allergy to normal saline

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Aslan Cetin B, Aydogan Mathyk B, Barut S, Koroglu N, Zindar Y, Konal M, Atis Aydin A. The impact of subcutaneous irrigation on wound complications after cesarean sections: A prospective randomised study. Eur J Obstet Gynecol Reprod Biol. 2018 Aug;227:67-70. doi: 10.1016/j.ejogrb.2018.06.006. Epub 2018 Jun 7. PMID 29894926
• Eke AC, Shukr GH, Chaalan TT, Nashif SK, Eleje GU. Intra-abdominal saline irrigation at cesarean section: a systematic review and meta-analysis. J Matern Fetal Neonatal Med. 2016;29(10):1588-94. doi: 10.3109/14767058.2015.1055723. PMID 26291302
• Viney R, Isaacs C, Chelmow D. Intra-abdominal irrigation at cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2012 Jun;119(6):1106-11. doi: 10.1097/AOG.0b013e3182460d09. PMID 22617574
• Harrigill KM, Miller HS, Haynes DE. The effect of intraabdominal irrigation at cesarean delivery on maternal morbidity: a randomized trial. Obstet Gynecol. 2003 Jan;101(1):80-5. doi: 10.1016/s0029-7844(02)02466-3. PMID 12517650
• Mackeen AD, Packard RE, Ota E, Berghella V, Baxter JK. Timing of intravenous prophylactic antibiotics for preventing postpartum infectious morbidity in women undergoing cesarean delivery. Cochrane Database Syst Rev. 2014 Dec 5;2014(12):CD009516. doi: 10.1002/14651858.CD009516.pub2. PMID 25479008
• Zuarez-Easton S, Zafran N, Garmi G, Salim R. Postcesarean wound infection: prevalence, impact, prevention, and management challenges. Int J Womens Health. 2017 Feb 17;9:81-88. doi: 10.2147/IJWH.S98876. eCollection 2017. PMID 28255256
• Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016. PMID 26849801

Идентификаторы

NCT: NCT07730060 · ISICS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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