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Completed

NCT Number: NCT06320548

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

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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Key information

Conditions

Cesarean Section Complications

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sapienza University of Rome

Rome, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-residue diet

Dietary Supplement

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

Free diet

Dietary Supplement

Patients had free diet.

Primary outcomes

  1. Number of participants who have passage of flatus within the first 24 hours after caesarean section.

    Time frame: 24 hours after surgery

    The primary outcome was postoperative ileus at 24 hours after caesarean section, the passage of flatus within the first 24 hours after caesarean section.

Secondary outcomes

  1. Postoperative pain

    Time frame: 12, 24, and 48 hours after surgery

    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".

  2. Postoperative complications

    Time frame: 24-48 hours after surgery

    Postoperative complications were classified according Clavien-Dindo classification system used to describe grade I-IV postoperative complications.

  3. Quality of the surgical field

    Time frame: Intraoperatively

    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.

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 20, 2024
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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