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

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Dietary supplement: Low-residue diet; Dietary supplement: Free diet

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy
    • Sapienza University of Rome

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-residue diet; Patients received clear explanations, practical schemes, and a list of allowed foods, tailored to fit individual needs.	Dietary supplement: Low-residue diet; Patients received clear explanations, practical schemes, and a list of allowed foods, tailored to fit individual needs.
Active Comparator: Free diet; Patients had free diet.	Dietary supplement: Free diet; Patients had free diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): December 2, 2020

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: cesarean section; postoperative ileus; enhanced recovery after surgery; obstetrics; perioperative management; low-residue diet
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Ileus
• Other Study ID Numbers: 0724/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No