Small Bowel ObstructionNCT07150390
Aetiologies and Prognosis of Small Bowel Obstruction in Virgin Abdomen
An observational study of Small Bowel Obstruction and Small Bowel Obstruction Adhesion, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Small Bowel Obstruction, Small Bowel Obstruction Adhesion
- How many people
- 312 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Sep 2023
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Only patients without prior abdominal operations and with CT or surgical exploration confirmation of the diagnosis of SBO were included.
Who cannot join
- Patients with age less than 14 years were excluded in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 230020
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SBO-VA | small intestinal obstruction patients without a history of abdominal surgery (virgin abdomen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recurrence rate within 5 years after discharge
The recurrence rate of small bowel obstruction within 5 years after discharge
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Jan 2022
- Primary completion1 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel ObstructionStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 312 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaochun Ping, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150390
- Sponsor's protocol ID
- 2023-SR-340
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aetiologies and Prognosis of Small Bowel Obstruction in Virgin Abdomen
- ClinicalTrials.gov ID
- NCT07150390
- Acronym / sponsor ID
- 2023-SR-340
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBO-VA | – | –small intestinal obstruction patients without a history of abdominal surgery (virgin abdomen) |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Only patients without prior abdominal operations and with CT or surgical exploration confirmation of the diagnosis of SBO were included.
Key exclusion criteria (1 listed)
- Patients with age less than 14 years were excluded in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The recurrence rate within 5 years after discharge
Time frame: 5 years
The recurrence rate of small bowel obstruction within 5 years after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Bowel Obstruction and Small Bowel Obstruction Adhesion, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The recurrence rate within 5 years after discharge (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.