Small Intestine Length MeasurementDTDRPSBL-BSNCT05338567
Digital 3D Reconstruction Predicts Small Bowel Length
An observational study of Small Intestine Length Measurement, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
The prevalence of type 2 diabetes mellitus (T2DM) has been increasing annually worldwide, and the prevalence of diabetes has reached 11.6% in China. Laparoscopic Roux-en-Y gastric bypass (RYGB) is still widely accepted as a valid surgery in the treatment of obesity and T2DM. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Small Intestine Length Measurement
- What is being tested?
- Small intestine length measurement method
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 2 Oct 2019to 2 Oct 2023
- 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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who underwent bariatric surgery in our hospital
Who may be able to join
- Patients eligible for surgical treatment of T2DM were selected based on the Chinese Guidelines for the Surgical Treatment of Obesity and Type 2 Diabetes (2019 )
Who cannot join
- Adhesions, peritonitis, and patients who have had bowel resection (small intestine, colon or rectum) that hinder the measurement of the entire intestinal length
- Non-weight loss surgery patients whose incision is less than 6 cm are not suitable for measuring the length of the small intestine.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Daping hospital
Chongqing, 400042
fan Li, PhD, 68729350, levinecq@163.com
About this study
Official title: Digital Three-dimensional Reconstruction for Predicting Small Bowel Length in Bariatric Surgery
The prevalence of type 2 diabetes mellitus (T2DM) has been increasing annually worldwide, and the prevalence of diabetes has reached 11.6% in China. Laparoscopic Roux-en-Y gastric bypass (RYGB) is still widely accepted as a valid surgery in the treatment of obesity and T2DM. But still, there is no consensus on the ideal of the gastric bypass limb lengths. Reported lengths of biliopancreatic limb (BPL) and alimentary limb (AL) varied widely from 10-250 to 35-250 cm, and anatomical data show that the length of small intestine varies greatly among adults. Choosing the same small bowel bypass length for different individuals obviously cannot achieve the expected weight loss effect, and individuals with too short small intestine can cause severe malnutrition complications and even life-threatening conditions. Therefore, measurement of small bowel length is one of the prerequisites for performing precise RYGB. Intraoperative measurement of small bowel length can increase the operative time and the risk of surgical complications such as intestinal perforation. So, predicting the total length of the small intestine is very important for accurately performing bariatric surgery and avoiding the risk of surgical complications. In this study, we propose to perform 3D segmentation and reconstruction of the small intestine by acquiring abdominal CT data through digital technology, and predict the small intestine length by 3D digital measurement of the small intestine, and verify the digital measurement data by performing digital measurement data. Establish a small bowel length prediction model for bariatric surgery to develop a more accurate and personalized gastric bypass surgery plan for patients to obtain weight loss and glucose control.
- Conditions
- Small Intestine Length Measurement
- Being tested
- Small intestine length measurement method
- Keywords
- bariatric surgery, Roux-en-y gastric bypass, Type 2 diabetes mellitus, Three-Dimensional reconstruction
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small intestine length measurement methodDiagnostic test
Accuracy of digital 3D reconstruction for predicting small bowel length
| Study group | Role | What they receive |
|---|---|---|
| Open/laparoscopic surgery | Small bowel length measurement by laparoscopy or laparotomy | |
| 3D reconstruction | Small bowel length measurement by 3D digital model Receives: Diagnostic Test: Small intestine length measurement method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the accuracy of the predicted length of the small intestine
The accuracy of the 3D reconstruction method was judged by comparing the length of the small intestine measured by the open/laparoscopic surgery with the length of the small intestine calculated by the preoperative CT 3D reconstruction.
Measured: 2 years
Secondary outcomes (1)
Building prediction formulas through machine deep learning
Through robotic deep learning, the small intestine is automatically segmented, and the small intestine is reconstructed in three dimensions to calculate the length of the small intestine.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start2 Oct 2019
- Primary completion2 Oct 2023 (estimated)
- Study completion2 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Intestine Length MeasurementStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fan li, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Investigators
- fan Li, PhD, Study director, Army medical universtiy daping hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338567
- Sponsor's protocol ID
- 3DRABL-BS
- Acronym
- DTDRPSBL-BS
- Status last verified
- Jul 2022
- First submitted
- 14 Apr 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Three-dimensional Reconstruction for Predicting Small Bowel Length in Bariatric Surgery
- ClinicalTrials.gov ID
- NCT05338567
- Acronym / sponsor ID
- DTDRPSBL-BS / 3DRABL-BS
- Conditions
- Small Intestine Length Measurement
- Keywords
- bariatric surgery, Roux-en-y gastric bypass, Type 2 diabetes mellitus, Three-Dimensional reconstruction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 2 Oct 2023 (estimated)
- Study completion
- 2 Oct 2023 (estimated)
- First posted
- 21 Apr 2022 (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.
The prevalence of type 2 diabetes mellitus (T2DM) has been increasing annually worldwide, and the prevalence of diabetes has reached 11.6% in China. Laparoscopic Roux-en-Y gastric bypass (RYGB) is still widely accepted as a valid surgery in the treatment of obesity and T2DM. But still, there is no consensus on the ideal of the gastric bypass limb lengths. Reported lengths of biliopancreatic limb (BPL) and alimentary limb (AL) varied widely from 10-250 to 35-250 cm, and anatomical data show that the length of small intestine varies greatly among adults. Choosing the same small bowel bypass length for different individuals obviously cannot achieve the expected weight loss effect, and individuals with too short small intestine can cause severe malnutrition complications and even life-threatening conditions. Therefore, measurement of small bowel length is one of the prerequisites for performing precise RYGB. Intraoperative measurement of small bowel length can increase the operative time and the risk of surgical complications such as intestinal perforation. So, predicting the total length of the small intestine is very important for accurately performing bariatric surgery and avoiding the risk of surgical complications. In this study, we propose to perform 3D segmentation and reconstruction of the small intestine by acquiring abdominal CT data through digital technology, and predict the small intestine length by 3D digital measurement of the small intestine, and verify the digital measurement data by performing digital measurement data. Establish a small bowel length prediction model for bariatric surgery to develop a more accurate and personalized gastric bypass surgery plan for patients to obtain weight loss and glucose control.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open/laparoscopic surgery | – | –Small bowel length measurement by laparoscopy or laparotomy |
| 3D reconstruction | – | Diagnostic Test: Small intestine length measurement methodSmall bowel length measurement by 3D digital model |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent bariatric surgery in our hospital
Key inclusion criteria (1 listed)
- Patients eligible for surgical treatment of T2DM were selected based on the Chinese Guidelines for the Surgical Treatment of Obesity and Type 2 Diabetes (2019 )
Key exclusion criteria (2 listed)
- Adhesions, peritonitis, and patients who have had bowel resection (small intestine, colon or rectum) that hinder the measurement of the entire intestinal length
- Non-weight loss surgery patients whose incision is less than 6 cm are not suitable for measuring the length of the small intestine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small intestine length measurement methodAccuracy of digital 3D reconstruction for predicting small bowel length | Diagnostic test | 3D reconstruction |
Primary outcome
Validation of the accuracy of the predicted length of the small intestine
Time frame: 2 years
The accuracy of the 3D reconstruction method was judged by comparing the length of the small intestine measured by the open/laparoscopic surgery with the length of the small intestine calculated by the preoperative CT 3D reconstruction.
1 secondary outcome
Building prediction formulas through machine deep learning
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Small Intestine Length Measurement
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.
fan Li, PhD study director
Army medical universtiy daping hospital
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 Intestine Length Measurement, run by Daping Hospital and the Research Institute of Surgery of the Third Military 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 2 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: status not confirmed, as of the sponsor's last update on 20 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact fan Li, PhD (68729350, levinecq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the accuracy of the predicted length of the small intestine (time frame: 2 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 20 Jul 2022.