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

Not Applicable

Completed

• Conditions: Cesarean Section Complications
• Interventions: Dietary Supplement: Free diet; Dietary Supplement: Low-residue diet

• Registration Number: NCT06320548
• Lead Sponsor: University of Roma La Sapienza

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2020-11-30
• Study Completion: 2020-12-02
• Status Verified: 2024-03
• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-12
• Last Update Submitted: 2024-03-12
• Study First Posted: 2024-03-20
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 166

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Free diet	Free diet	Patients had free diet.
Low-residue diet	Low-residue diet	Patients received clear explanations, practical schemes, and a list of allowed foods, tailored to fit individual needs.

Primary Outcome Measures

Name	Time	Method
Number of participants who have passage of flatus within the first 24 hours after caesarean section.	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 Outcome Measures

Name	Time	Method
Postoperative complications	24-48 hours after surgery	Postoperative complications were classified according Clavien-Dindo classification system used to describe grade I-IV postoperative complications.
Quality of the surgical field	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.
Postoperative pain	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".

Trial Locations

Locations (1)

Sapienza University of Rome; 🇮🇹 Rome, Italy