NCT07150390

Brief Summary

Small bowel obstruction (SBO) is a surgical emergency in which the passage of intestinal contents is prevented due to mechanical obstruction of small intestine. It accounts for almost 50% of all emergency laparotomies with significant in-hospital morbidity and costs. SBO has known to occur in patients who had no prior abdominal surgery, referring to as a virgin abdomen (VA). Nowadays, non-operative management comprising of bowel decompression, water-soluble contrast agents, and fluid resuscitation have been found safe and efficacious in 70% of SBOs caused by adhesions (ASBO). However, based on the assumption that SBO in the virgin abdomen (SBO-VA) is usually caused by other aetiologies than adhesions, such as malignancy and hernias, many authors suggest that surgical exploration is still mandatory. Besides, recent studies do show high incidence of adhesions also in patients with SBO-VA. This observation signifies that guideline on the management of ASBO might also apply to the majority of patients with SBO-VA. Hence, the aim of our retrospectively study is to shed light on the aetiologies of SBO-VA. We believe treatment strategy needs to be based on the underlying reasons of obstructions and conditions of the patients and evaluate their prognosis accordingly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
312

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 2, 2025

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

1.6 years

First QC Date

August 25, 2025

Last Update Submit

August 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The recurrence rate within 5 years after discharge

    The recurrence rate of small bowel obstruction within 5 years after discharge

    5 years

Study Arms (1)

SBO-VA

small intestinal obstruction patients without a history of abdominal surgery (virgin abdomen)

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

From January 2009 to December 2020, 2098 consecutive patients with 2275 admissions who diagnosed with bowel obstuction were enrolled in the First Affiliated Hospital of Nanjing Medical University, P. R. China. For patients with multiple admissions, only the index admissions were included, the rest were used for follow-up analysis. The detailed medical records of those 2098 patients were collected and reviewed. Only patients without prior abdominal operations and with CT or surgical exploration confirmation of the diagnosis of SBO were included. In addition, patients with age less than 14 years were excluded in this study. The diagnosis of SBO was established if an attending surgeon documented interpretation of CT imaging and was in agreement with the diagnosis. Finally, 312 patients with SBO in virgin abdomen were included in this study.

You may qualify if:

  • Only patients without prior abdominal operations and with CT or surgical exploration confirmation of the diagnosis of SBO were included.

You may not qualify if:

  • Patients with age less than 14 years were excluded in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 230020, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief Physician

Study Record Dates

First Submitted

August 25, 2025

First Posted

September 2, 2025

Study Start

January 1, 2022

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

September 2, 2025

Record last verified: 2025-08

Locations