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The Efficacy of Preoperative Low-residue Diet on Postoperative Ileus Following Cesarean Section

The Efficacy of Preoperative Low-residue Diet on Postoperative Ileus Following Cesarean Section: A Randomized Controlled Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06320548
Enrollment
166
Registered
2024-03-20
Start date
2018-10-01
Completion date
2020-12-02
Last updated
2024-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Complications

Keywords

enhanced recovery after surgery, low-residue diet, obstetrics, perioperative management, cesarean section, postoperative ileus

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTLow-residue diet

Patients received clear explanations, practical schemes, and a list of allowed foods, tailored to fit individual needs.

DIETARY_SUPPLEMENTFree diet

Patients had free diet.

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Pregnant women at ≥39 weeks of gestation scheduled for elective cesarean section at the Department of Gynecology of Policlinico Umberto I (Sapienza University of Rome) who gave written informed consent.

Exclusion criteria

* Urgent/emergent surgery * Patients with gastrointestinal disorders * Complicated pregnancy (e.g., active infection, placental adhesive disorders, hypertensive disorders), which would potentially prolong their hospitalization * Incomplete medical records.

Design outcomes

Primary

MeasureTime frameDescription
Number of participants who have passage of flatus within the first 24 hours after caesarean section.24 hours after surgeryThe primary outcome was postoperative ileus at 24 hours after caesarean section, the passage of flatus within the first 24 hours after caesarean section.

Secondary

MeasureTime frameDescription
Postoperative pain12, 24, and 48 hours after surgeryPostoperative 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.
Postoperative complications24-48 hours after surgeryPostoperative complications were classified according Clavien-Dindo classification system used to describe grade I-IV postoperative complications.
Quality of the surgical fieldIntraoperativelyThe 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026