Cesarean Section ComplicationsNCT06320548
The Efficacy of Preoperative Low-residue Diet on Postoperative Ileus Following Cesarean Section
A study testing Low-residue diet and Free diet in people with Cesarean Section Complications, run by University of Roma La Sapienza at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Low-residue diet and Free diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2018to 2 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cesarean Section Complications
- Being tested
- Low-residue diet, Free diet
- Keywords
- enhanced recovery after surgery, low-residue diet, obstetrics, perioperative management, cesarean section, postoperative ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-residue dietDietary supplement
Patients received clear explanations, practical schemes, and a list of allowed foods, tailored to fit individual needs.
Free dietDietary supplement
Patients had free diet.
| Study group | Role | What they receive |
|---|---|---|
| Low-residue diet | Experimental | Patients received clear explanations, practical schemes, and a list of allowed foods, tailored to fit individual needs. Receives: Dietary Supplement: Low-residue diet |
| Free diet | Active comparator | Patients had free diet. Receives: Dietary Supplement: Free diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after surgery
Secondary outcomes (3)
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".
Measured: 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.
Measured: 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.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 Oct 2018
- Primary completion30 Nov 2020
- Study completion2 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Caruso, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320548
- Sponsor's protocol ID
- 0724/2018
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Preoperative Low-residue Diet on Postoperative Ileus Following Cesarean Section: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06320548
- Acronym / sponsor ID
- 0724/2018
- Conditions
- Cesarean Section Complications
- Keywords
- enhanced recovery after surgery, low-residue diet, obstetrics, perioperative management, cesarean section, postoperative ileus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 2 Dec 2020 (actual)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-residue diet | Experimental | Dietary Supplement: Low-residue dietPatients received clear explanations, practical schemes, and a list of allowed foods, tailored to fit individual needs. |
| Free diet | Active comparator | Dietary Supplement: Free dietPatients had free diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-residue dietPatients received clear explanations, practical schemes, and a list of allowed foods, tailored to fit individual needs. | Dietary supplement | Low-residue diet |
| Free dietPatients had free diet. | Dietary supplement | Free diet |
Primary outcome
Number of participants who have passage of flatus within the first 24 hours after caesarean section.
Time frame: 24 hours after surgery
The primary outcome was postoperative ileus at 24 hours after caesarean section, the passage of flatus within the first 24 hours after caesarean section.
3 secondary outcomes
Postoperative pain
Time frame: 12, 24, and 48 hours after surgery
Postoperative complications
Time frame: 24-48 hours after surgery
Quality of the surgical field
Time frame: Intraoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
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Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
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Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-residue diet and Free diet in people with Cesarean Section Complications, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who have passage of flatus within the first 24 hours after caesarean section. (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.