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Clinical Trials/NCT07730060
NCT07730060Not yet recruitingNot Applicable

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

Assiut University0 sites150 target enrollmentStarted: July 1, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
150
Primary Endpoint
Postoperative infectious morbidity within 6 weeks

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Postoperative infectious morbidity within 6 weeks

Time Frame: 6 Week

defined as fever ≥ 38°C, wound infection, or endometritis.

Paralytic ileus

Time Frame: baseline

Time to first passage of flatus in hours, and time to first bowel motion in hours.

Secondary Outcomes

  • Length of hospital stay in days(6 week)
  • Readmission rate within 6 weeks(6 week)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Abeer Abdelbaset Gheiat

Docter

Assiut University

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