Peritoneal Irrigation at Elective Cesarean Section

January 26, 2018 updated by: Ahmed Maged, Cairo University

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12151
        • Kasr Alainy medical school

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Singleton pregnancy
  • Gestational age 36 - 40 weeks
  • Elective Cesarean section
  • Under spinal anaesthesia

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Peritoneal irrigation
Irrigation with 500 - 1000 ml of warm normal saline will be done after closure of visceral peritoneum
Procedure: Elective Cesarean Section
lower segment cesarean section
Other Names:
  • CS
Other: Peritoneal irrigation
Irrigation of peritoneal cavity with 500 - 1000 ml of warm normal saline
ACTIVE_COMPARATOR: Non peritoneal irrigation
No Irrigation with 500 - 1000 ml of warm normal saline will be done after closure of visceral peritoneum
Procedure: Elective Cesarean Section
lower segment cesarean section
Other Names:
  • CS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intestinal recovery
Time Frame: 24 hours after operation
Auscultation of intestinal sounds
24 hours after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temperature
Time Frame: every hour for 16 hours after the operation
measuring the oral temperature by thermometer
every hour for 16 hours after the operation
postoperative pain
Time Frame: 24 hours after surgery
Pain score felt by the patient using Visual analogue score
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2018

Primary Completion (ANTICIPATED)

June 1, 2018

Study Completion (ANTICIPATED)

July 1, 2018

Study Registration Dates

First Submitted

January 22, 2018

First Submitted That Met QC Criteria

January 26, 2018

First Posted (ACTUAL)

January 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 29, 2018

Last Update Submitted That Met QC Criteria

January 26, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 23 (SIME)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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