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

NCT ID: NCT06320548

Last Updated: 2024-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-12-02

Brief Summary

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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

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Conditions

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Cesarean Section Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Low-residue diet

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

Group Type EXPERIMENTAL

Low-residue diet

Intervention Type DIETARY_SUPPLEMENT

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

Free diet

Patients had free diet.

Group Type ACTIVE_COMPARATOR

Free diet

Intervention Type DIETARY_SUPPLEMENT

Patients had free diet.

Interventions

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Low-residue diet

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

Intervention Type DIETARY_SUPPLEMENT

Free diet

Patients had free diet.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Caruso

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sapienza University of Rome

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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0724/2018

Identifier Type: -

Identifier Source: org_study_id

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