An interventional study of Low-residue diet and Free diet in Cesarean Section Complications, sponsored by University of Roma La Sapienza. Completed at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-20.
Sponsored by University of Roma La Sapienza · Not applicable, Interventional, and Supportive care
The aim of the present study was to evaluate the efficacy of preoperative low-residue diet on postoperative ileus in women undergoing elective cesarean section. It is a surgeon-blind, randomized controlled trial enrolling pregnant women at ≥39 weeks of gestation undergoing elective cesarean section. Patients were preoperatively randomized to receive either low-residue diet (arm A) or free diet (arm B) starting from three days before surgery. The primary outcome was the postoperative ileus at 24 hours after surgery. The secondary outcomes were the postoperative pain (assessed through VAS scale), the quality of the surgical field (scored using a 5-point scale, from poor to excellent), postoperative complications, and the length of hospital stay. Perioperative data were collected and compared between groups.
Exclusion Criteria:
Patients received clear explanations, practical schemes, and a list of allowed foods, tailored to fit individual needs.
Dietary Supplement: Low-residue diet
Patients had free diet.
Dietary Supplement: Free diet
Patients received clear explanations, practical schemes, and a list of allowed foods, tailored to fit individual needs.
Patients had free diet.
Number of participants who have passage of flatus within the first 24 hours after caesarean section.
The primary outcome was postoperative ileus at 24 hours after caesarean section, the passage of flatus within the first 24 hours after caesarean section.
Time frame: 24 hours after surgery
Postoperative pain
Postoperative pain at 12, 24 and 48 hours postoperatively, assessed using the Visual Analogue Scale scale. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain".
Time frame: 12, 24, and 48 hours after surgery
Postoperative complications
Postoperative complications were classified according Clavien-Dindo classification system used to describe grade I-IV postoperative complications.
Time frame: 24-48 hours after surgery
Quality of the surgical field
The degree of small and large bowel preparation and the overall appropriateness of the surgical field was assessed by the surgeon using a 5-point scale (poor, sufficient, medium, good, excellent), based on the Leiden-surgical rating scale.
Time frame: Intraoperatively
Plan to share: No
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University of Roma La Sapienza