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

N/ACompletedNCT06320548

University of Roma La Sapienza166 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

166

Conditions

Cesarean Section Complications

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 24 hours after surgery

Secondary Outcomes

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".

Time frame: 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.

Time frame: 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.

Time frame: Intraoperatively