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

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06320548
• Other study ID #: 0724/2018
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 2, 2020

Study information

• Verified date: March 2024
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: December 2, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section Complications
• Ileus

Intervention

Dietary Supplement:
• Low-residue diet
Patients received clear explanations, practical schemes, and a list of allowed foods, tailored to fit individual needs.
• Free diet
Patients had free diet.

Locations

Country	Name	City	State
Italy	Sapienza University of Rome	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Postoperative complications	Postoperative complications were classified according Clavien-Dindo classification system used to describe grade I-IV postoperative complications.	24-48 hours after surgery
Secondary	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