Percutaneous Sigmoid Fixation For Management Of Recurrent Sigmoid Volvulus

NCT07155304 | Completed

• 1 other identifier: Mahmoud Alballat
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators included all patients who were presented to emergency department with recurrent sigmoid volvulus at Zagazig University hospital between (August 2024 to August 2025). The investigators included patients were of the American Society of Anesthesiologists (ASA) Physical status I-II-III-IV, high risk surgical patients and patients with age of 16-80 years old while excluded patients with ASA V, VI, patients with lower abdominal surgery and obese patients with body mass index more than 35. This prospective randomized controlled clinical trial was approved by Zagazig University Faculty of Medicine Institutional Review Board (Approval Number: 633/1-Sep-2024) and performed in accordance with the code of ethics of the World Medical Association (Declaration of Helsinki) for studies involving human subjects.

Conditions

Endoscopic Surgical Procedure

Keywords

endoscopy, volvulus,

Outcome Measures

Primary Outcomes (1)

• incidence of recurrence of volvulus

  incidence of recurrence of volvulus

  within one week after the endoscopy

Study Arms (2)

percutaneous group

ACTIVE COMPARATOR

percutaneous fixation of sigmoid volvulus after endoscopic untwisting to prevent recurrence using anchor device

Procedure: percutaneous sigmoid colon fixation

surgical group

NO INTERVENTION

surgical management of sigmoid volvulus

Interventions

percutaneous sigmoid colon fixation PROCEDURE

after endoscopic sigmoid colon untwisting , percutaneous colon fixation using anchor device

percutaneous group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) Physical status I-II-III-IV, high risk surgical patients and patients with age of 16-80 years old

You may not qualify if:

• patients with ASA V, VI, patients with lower abdominal surgery and obese patients with body mass index more than 35

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University

Zagazig, Sharquia, 7120730, Egypt

Location

MeSH Terms

Conditions

Intestinal Volvulus

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Torsion Abnormality; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Said Mohamed Negm, M.D

  Zagazig University Faculty Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of general surgery

Model Details: The investigators included all patients who were presented to emergency department with recurrent sigmoid volvulus at Zagazig University hospital between (August 2024 to August 2025). Sample size in this study was calculated based on comparison of mortality rate after endoscopy and surgical procedure in elderly patients with sigmoid volvulus as primary outcome for this study. Prior data from (Jackson et al., 2020) revealed that mortality rate after surgical intervention was 16-42% and after percutaneous fixation was 9.7%. So, using power and sample size calculator we included 33 patients in the surgical group(group1) and 33 patients in the percutaneous group (group2) to be able to reject the null hypothesis that mortality rates for both groups' subjects were equal with probability (power) 0.8. The type I error probability associated with this test of this null hypothesis was 0.05. We used an uncorrected chi-squared statistic to evaluate this null hypothesis. Dropout rate was 20%.

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 4, 2025
• Study Start: August 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

EG (1)