Postoperative RecoveryNCT03413748
Peritoneal Irrigation at Elective Cesarean Section
A study testing Elective Cesarean Section and Peritoneal irrigation in people with Postoperative Recovery, run by Cairo University at 1 site in Egypt.
Trial summary
All participants will be randomized at elective cesarean section to either irrigation with 500 to 1000 ml of warm normal saline after closure of visceral peritoneum or non irrigation Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Postoperative Recovery
- What is being tested?
- Elective Cesarean Section and Peritoneal irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2018to Jul 2018
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancy
- Gestational age 36 - 40 weeks
- Elective Cesarean section
- Under spinal anaesthesia
Who cannot join
- Chronic diseases as Diabetes and hypertension
- Intestinal diseases as Crohn's disease
- Psychological and neurological conditions affecting pain sensation
- women with ferbrile morbidity before the operation
- The need for general anesthesia
Trial locations and contacts
1 site in 1 country.
Amira Yehia, MD contact
About this study
Official title: Comparative Study Between Intraabdominal Irrigation and Non Irrigation During Elective Cesarean Section
All participants will be randomized at elective cesarean section to either irrigation with 500 to 1000 ml of warm normal saline after closure of visceral peritoneum or non irrigation
Read the detailed description
All participants will be randomized at elective cesarean section to either irrigation with 500 to 1000 ml of warm normal saline after closure of visceral peritoneum or non irrigation during the procedure of elective lower segment cesarean section
- Conditions
- Postoperative Recovery
- Being tested
- Elective Cesarean Section, Peritoneal irrigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective Cesarean SectionProcedure or surgery
Also called CS
lower segment cesarean section
Peritoneal irrigationOther
Irrigation of peritoneal cavity with 500 - 1000 ml of warm normal saline
| Study group | Role | What they receive |
|---|---|---|
| Peritoneal irrigation | Active comparator | Irrigation with 500 - 1000 ml of warm normal saline will be done after closure of visceral peritoneum Receives: Procedure: Elective Cesarean Section; Other: Peritoneal irrigation |
| Non peritoneal irrigation | Active comparator | No Irrigation with 500 - 1000 ml of warm normal saline will be done after closure of visceral peritoneum Receives: Procedure: Elective Cesarean Section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal recovery
Auscultation of intestinal sounds
Measured: 24 hours after operation
Secondary outcomes (2)
Temperature
measuring the oral temperature by thermometer
Measured: every hour for 16 hours after the operation
postoperative pain
Pain score felt by the patient using Visual analogue score
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study startJan 2018 (estimated)
- Primary completionJun 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative RecoveryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413748
- Sponsor's protocol ID
- 23
- Status last verified
- Jan 2018
- First submitted
- 22 Jan 2018
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Intraabdominal Irrigation and Non Irrigation During Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT03413748
- Acronym / sponsor ID
- 23
- Conditions
- Postoperative Recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 29 Jan 2018 (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.
All participants will be randomized at elective cesarean section to either irrigation with 500 to 1000 ml of warm normal saline after closure of visceral peritoneum or non irrigation
Detailed description
All participants will be randomized at elective cesarean section to either irrigation with 500 to 1000 ml of warm normal saline after closure of visceral peritoneum or non irrigation during the procedure of elective lower segment cesarean section
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peritoneal irrigation | Active comparator | Procedure: Elective Cesarean Section, Other: Peritoneal irrigationIrrigation with 500 - 1000 ml of warm normal saline will be done after closure of visceral peritoneum |
| Non peritoneal irrigation | Active comparator | Procedure: Elective Cesarean SectionNo Irrigation with 500 - 1000 ml of warm normal saline will be done after closure of visceral peritoneum |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Singleton pregnancy
- Gestational age 36 - 40 weeks
- Elective Cesarean section
- Under spinal anaesthesia
Key exclusion criteria (5 listed)
- Chronic diseases as Diabetes and hypertension
- Intestinal diseases as Crohn's disease
- Psychological and neurological conditions affecting pain sensation
- women with ferbrile morbidity before the operation
- The need for general anesthesia
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 |
|---|---|---|
| Elective Cesarean SectionAlso: CSlower segment cesarean section | Procedure or surgery | Non peritoneal irrigation, Peritoneal irrigation |
| Peritoneal irrigationIrrigation of peritoneal cavity with 500 - 1000 ml of warm normal saline | Other | Peritoneal irrigation |
Primary outcome
Intestinal recovery
Time frame: 24 hours after operation
Auscultation of intestinal sounds
2 secondary outcomes
Temperature
Time frame: every hour for 16 hours after the operation
postoperative pain
Time frame: 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Amira Yehia, MD contact
Ahmed Maged, MD principal investigator
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elective Cesarean Section and Peritoneal irrigation in people with Postoperative Recovery, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Jan 2018. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Maged, MD (+2001005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal recovery (time frame: 24 hours after operation). 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 29 Jan 2018; AzTrials last refreshed its copy on 4 Nov 2026.