NCT05654649

Brief Summary

Postoperative ileus is a perplexing problem for clinical surgeons. It occurs not only after abdominal surgery but also after any surgery that requires general anesthesia. Postoperative ileus is defined as the dysfunction of gastrointestinal motility after surgery, characterized by a decrease in, or stagnation of, intestinal peristalsis.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

2 years

First QC Date

December 8, 2022

Last Update Submit

November 28, 2024

Conditions

Postoperative Ileus

Outcome Measures

Primary Outcomes (1)

  • the time to first passage of flatus and or stool

    the time to first passage of flatus and or stool through the first 24 hours and the time of return of intestinal sounds,

    24 hours postoperative

Study Arms (2)

Group C

PLACEBO COMPARATOR

Patients received 5 ml of IV normal saline as a placebo just before spinal anesthesia

Drug: 0.9%sodium chloride

Group D

ACTIVE COMPARATOR

Patients received IV dexamethasone 8 mg in 5ml normal saline 0,9%, just before spinal anesthesia.

Drug: Dexamethasone

Interventions

0.9%sodium chlorideDRUG

Patients received 5 ml of IV normal saline as a placebo just before spinal anesthesia

Group C
DexamethasoneDRUG

Patients received IV dexamethasone 8 mg in 5ml normal saline 0,9%, just before spinal anesthesia.

Group D

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All patients 18-40 years of full-term singleton pregnancy (37-41 weeks).,
  • American Society of Anaesthesiologists (ASA) classification class I and II scheduled.
  • for elective or semi-elective surgery (category 3 and 4 Caesarean sections).
  • All patients under spinal anesthesia for a Single baby pregnancy of more than 32 weeks will be included in this study.

You may not qualify if:

  • will be patients' height \< 150 or \> 180 cm.
  • Body mass index (BMI) \>35 kg m-2.
  • Contraindication or refusal to undergo regional anesthesia.
  • any cardiovascular disease including arrhythmias and severe stenotic valvular heart disease.any renal or hepatic diseased patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

woman health hospital , Assiut university

Asyut, 71515, Egypt

RECRUITING

Related Publications (4)

  • Deng WW, Lan M, Peng AF, Chen T, Li ZQ, Liu ZL, Liu JM. The risk factors for postoperative ileus following posterior thoraco-lumbar spinal fusion surgery. Clin Neurol Neurosurg. 2019 Sep;184:105411. doi: 10.1016/j.clineuro.2019.105411. Epub 2019 Jul 1.

    PMID: 31310924BACKGROUND

  • Petca A, Borislavschi A, Dumitrascu MC, Sandru F, Geoarsa M, Petca RC. Postoperative Ileus Complicated with Incomplete Evisceration after Hysterectomy for Benign Pathology. Chirurgia (Bucur). 2020 Jan-Feb;115(1):112-119. doi: 10.21614/chirurgia.115.1.112.

    PMID: 32155406BACKGROUND

  • Holte K, Kehlet H. Postoperative ileus: a preventable event. Br J Surg. 2000 Nov;87(11):1480-93. doi: 10.1046/j.1365-2168.2000.01595.x.

    PMID: 11091234BACKGROUND

  • Tevis SE, Carchman EH, Foley EF, Harms BA, Heise CP, Kennedy GD. Postoperative Ileus--More than Just Prolonged Length of Stay? J Gastrointest Surg. 2015 Sep;19(9):1684-90. doi: 10.1007/s11605-015-2877-1. Epub 2015 Jun 24.

    PMID: 26105552BACKGROUND

MeSH Terms

Interventions

Sodium ChlorideDexamethasone

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Central Study Contacts

Ghada Abo Elfadl, MD

CONTACT

01005802086ghadafadl77@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 8, 2022

First Posted

December 16, 2022

Study Start

December 1, 2022

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

December 2, 2024

Record last verified: 2024-11

Locations

EG(1)