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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-residue diet | Experimental | Patients received clear explanations, practical schemes, and a list of allowed foods, tailored to fit individual needs. |
|
| Free diet | Active Comparator | Patients had free diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-residue diet | Dietary Supplement | Patients received clear explanations, practical schemes, and a list of allowed foods, tailored to fit individual needs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | 12, 24, and 48 hours after surgery |
| Postoperative complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapienza University of Rome | Rome | Italy |
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| Free diet | Dietary Supplement | Patients had free diet. |
|
Postoperative complications were classified according Clavien-Dindo classification system used to describe grade I-IV postoperative complications. |
| 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. | Intraoperatively |