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

NCT05620446 | Completed

• 1 other identifier: Ahmed Shafiq
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

endoscopic surgery

Outcome Measures

Primary Outcomes (1)

• efficacy and safety of endoscopic management of acute sigmoid volvulus

  incidence of postoperative complication

  within one week after intervention

Secondary Outcomes (1)

• efficacy of endoscopic management of acute sigmoid volvulus

  within 6 month post operative

Study Arms (2)

endoscopic managment of sigmoid volvulus

ACTIVE COMPARATOR

patients are subjected to untwist the volvulus first by endoscopy then one or two days later are subjected to sigmoid colon fixation by endoscopy using 2-shot anchor device

Procedure: endoscopy

surgical management of sigmoid volvulus

NO INTERVENTION

patients aresubjected for surgical colostomy ( hartman's procedure ) , then later on after 6 weeks , they are subjected for surgical sigmoid fixation or excision either by open or laparoscopic approach

Interventions

endoscopy PROCEDURE

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 .

endoscopic managment of sigmoid volvulus

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 comorbidities
• patients on sepsis but not septic shock

You may not qualify if:

• patients with good general condition (ASAI\&II),
• patients with age below 60 years ,
• patients with bowel ischemia
• patients managed by rectal deflating tube

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, Sharquia, 1185, Egypt

Location

Related Publications (1)

• Negm S, Farag A, Shafiq A, Moursi A, Abdelghani AA. Endoscopic management of acute sigmoid volvulus in high risk surgical elderly patients: a randomized controlled trial. Langenbecks Arch Surg. 2023 Aug 28;408(1):338. doi: 10.1007/s00423-023-03071-4.

  PMID: 37635200 DERIVED

MeSH Terms

Interventions

Endoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Said Mohamed Negm, MD

  Zagazig University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: no masking
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of general surgery

Model Details: 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), 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

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 17, 2022
• Study Start: December 10, 2020
• Primary Completion: August 10, 2022
• Study Completion: November 10, 2022
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)