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

NCT05620446 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-11-17

No results posted yet for this study

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.

Conditions

  • Elderly Patient Withsigmoid Volvulus

Interventions

PROCEDURE

endoscopy

the technique was done by two doctor the patients were sedated then colonoscopy was done for the patients while the patients were put in lithotomy position , we identified the site of sigmoid colon fixation by radiological colongraphy then tip of artery forceps was moved at outer skin at anterior abdominal wall at left lower quadrant to meet tip of colonscopy at multiple point where fixation was done . fixation was done by exploratory puncture of skin by scalpel about (2-3 mm puncture) at site of these points then widening the puncture by artery forceps at level of subcutaneous tissue. A 2- shot anchor device was used to fix the sigmoid colon against anterior abdominal wall. The 2-shot anchor device was passed through the puncture to be entered inside the sigmoid colon and the thread with a metal T-bar was detachd and pulled towards the anterior abdominal wall. This was repeated at multiple point of fixation .

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Principal Investigators

  • Said Mohamed Negm, MD · Zagazig University Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-10
Primary Completion
2022-08-10
Completion
2022-11-10

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05620446 on ClinicalTrials.gov