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Completed NCT05620446

Endoscopic Management of Acute Sigmoid Volvulus in High Risk Surgical Eldery Patients: A Randomized Controlled Trial.

Conditions: Elderly Patient Withsigmoid Volvulus

Sex: All
Ages: 60 Years – N/A
Phase: NA
Enrollment: 18
Sponsor: Zagazig University

Location: Egypt

Summary

This prospective randomized controlled clinical trial included all patients who developed the manifestations of acute a cute sigmoid volvulus and referred to the Zagazig University Hospital Emergency Department between December 2020 and August 2022. The study was prospectively approved by Zagazig University Faculty of Medicine Institutional Review Board (Approval Number: 9989/23-10-2022), Patients with age of ≥60 years-old , with acute sigmoid volvulus not managed by rectal deflating tube, with no evidence of bowel ischemia, with ASA III & IV , high risk surgical patients , with comorbidities and on sepsis but not septic shock were included and eligible for randomization. We excluded patients who were with good general condition (ASAI&II), patients with age below 60 years , patients with bowel ischemia and patients managed by rectal deflating tube.Included eligible patients were simply randomized at a 1:1 ratio to "Endoscopic (SG)" or "Surgical Colostomy Group (EG)" via the drawing of sealed envelopes containing computer-generated random numbers prepared by a third party before the start of the intervention.

Eligibility Criteria

Inclusion Criteria:Patients with age of ≥60 years-old ,patients with acute sigmoid volvulus not managed by rectal deflating tube,patients with no evidence of bowel ischemia,patients with ASA III & IV , high risk surgical patients ,patientswith comorbiditiespatients on sepsis but not septic shockExclusion Criteria:patients with good general condition (ASAI&II),patients with age below 60 years ,patients with bowel ischemiapatients managed by rectal deflating tube

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05620446). StuddyBuddy aggregates publicly available trial information.