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

NCT06320548 | Completed

• 1 other identifier: 0724/2018
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section Complications

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Postoperative pain

  12, 24, and 48 hours after surgery

• Postoperative complications

  24-48 hours after surgery

• Quality of the surgical field

  Intraoperatively

Study Arms (2)

Low-residue diet

EXPERIMENTAL

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

Dietary Supplement: Low-residue diet

Free diet

ACTIVE COMPARATOR

Patients had free diet.

Dietary Supplement: Free diet

Interventions

Low-residue diet DIETARY_SUPPLEMENT

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

Low-residue diet

Free diet DIETARY_SUPPLEMENT

Patients had free diet.

Free diet

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University of Rome

Rome, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 20, 2024
• Study Start: October 1, 2018
• Primary Completion: November 30, 2020
• Study Completion: December 2, 2020
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)