Small Intestine LengthNCT06696677
Small Intestine Length Measurement Using 3D CT Volumetry and in Vivo Measurement Using Pre-marked Graspers in Revisional Bariatric Surgeries. A Comparative Study
A study testing CT and Measuring the small instestine length using pre-marked laparoscopic graspers in people with Small Intestine Length, run by Kasr El Aini Hospital at 2 sites in Egypt.
Trial summary
Measuring bowel length during hypo-absorptive surgeries like Roux-en-Y gastric bypass (RYGB) and Single Anastomosis Duodeno-ileal Sleeve (SADI-s) is controversial and usually abandoned due to the high risk of intestinal injury. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Small Intestine Length
- What is being tested?
- CT and Measuring the small instestine length using pre-marked laparoscopic graspers
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 26 Jan 2025to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who are candidates for revisional bariatric surgery
- Patients consenting to participate in the study.
Who cannot join
- Patients with severe adhesions where measuring the small bowel may expose them to unnecessary injuries.
- Patients refusing to participate in the study.
- Patient refusing CT scan to be done pre-operatively.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Kasr Alainy Medical School, Cairo University
Cairo, Old Cairo, 11956
Maher M Fawzy, Doctorate, +201222166937, kasralainyrec@kasralainy.edu.eg
Ahmed M Ghobashy
- Not yet recruiting
Kasr Alainy Medical School, Cairo University
Cairo
Ahmed Mohammed
About this study
Measuring bowel length during hypo-absorptive surgeries like Roux-en-Y gastric bypass (RYGB) and Single Anastomosis Duodeno-ileal Sleeve (SADI-s) is controversial and usually abandoned due to the high risk of intestinal injury. However, some surgeons, especially in revisional surgery, prefer to count the whole bowel length to avoid leaving very short segments and severe malnutrition afterwards.
3D reconstructed CT scan can be useful in such conditions, avoiding the risk of intestinal injury, but accurate measures might be doubtful.
- Conditions
- Small Intestine Length
- Being tested
- CT, Measuring the small instestine length using pre-marked laparoscopic graspers
- Keywords
- Small bowel Length, reconstructed 3D CT scan, Revisions bariatric Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTDiagnostic test
CT measurment of small bowel
Measuring the small instestine length using pre-marked laparoscopic graspersProcedure or surgery
Intra-operatively, the surgeon will assess the length of the small intestine using a 5-cm marked laparoscopic graspers to accurately assess the whole small intestine length.
| Study group | Role | What they receive |
|---|---|---|
| Marked Laparoscopic graspers group | Active comparator | in this arm, the graspers will be marked by a sterile tape, 5 cm in length. This will help for accurate measuring of the whole intestine. Receives: Procedure: Measuring the small instestine length using pre-marked laparoscopic graspers |
| 3D CT scan group | Active comparator | In this arm, all patients involved in the study will have a pre-operative CT scan, for which a 3D reconstruction will be done and measure the whole small intestinal length. Receives: Diagnostic Test: CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accurate small bowel length
the aim of the study to assess if the CT scan with 3D reconstruction will give accurate measures for the bowel length compared to the marked graspers used in laparoscopic surgery
Measured: about 6 months
Secondary outcomes (2)
Operative time
measuring the whole bowel length may increase the operative time according to the skills of the surgeon, the presence of adhesions, and short mesentery.
Measured: intraoperative
Intestinal Injury
counting the whole bowel length is a tedious procedure, especially in patients with obesity, where the mesentery is dense and may cause injury to the bowel.
In this study, we will assess the incidence of intestinal injury of the small bowel, detected intra-operatively or post-operatively.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start26 Jan 2025 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Small Intestine LengthStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is a prospective cross-sectional analytic study designed to compare two methods of small bowel length measurement: preoperative 3D CT volumetry and intraoperative laparoscopic measurement using pre-marked graspers. The study will include adult patients undergoing revisional bariatric surgeries at Kasr AlAiny Hospitals. All participants will undergo preoperative imaging and intraoperative measurements, with results analyzed to determine the accuracy and correlation between the two methods.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelsalam M, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696677
- Sponsor's protocol ID
- TSBL06052024
- Status last verified
- Nov 2024
- First submitted
- 5 Oct 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Massalou D, Bege T, Bourgouin S, Mancini J, Masson C, Baque P, Berdah SV. Three-dimensional variability of the mesentery and the superior mesenteric artery: application to virtual trauma modeling. Surg Radiol Anat. 2014 May;36(4):401-8. doi: 10.1007/s00276-013-1178-1. Epub 2013 Jul 31.
PubMed 23900506Zorrilla-Nunez LF, Campbell A, Giambartolomei G, Lo Menzo E, Szomstein S, Rosenthal RJ. The importance of the biliopancreatic limb length in gastric bypass: A systematic review. Surg Obes Relat Dis. 2019 Jan;15(1):43-49. doi: 10.1016/j.soard.2018.10.013. Epub 2018 Oct 22.
PubMed 30501957Ahuja A, Tantia O, Goyal G, Chaudhuri T, Khanna S, Poddar A, Gupta S, Majumdar K. MGB-OAGB: Effect of Biliopancreatic Limb Length on Nutritional Deficiency, Weight Loss, and Comorbidity Resolution. Obes Surg. 2018 Nov;28(11):3439-3445. doi: 10.1007/s11695-018-3405-7.
PubMed 30032419Mahawar KK, Parmar C, Carr WRJ, Jennings N, Schroeder N, Small PK. Impact of biliopancreatic limb length on severe protein-calorie malnutrition requiring revisional surgery after one anastomosis (mini) gastric bypass. J Minim Access Surg. 2018 Jan-Mar;14(1):37-43. doi: 10.4103/jmas.JMAS_198_16.
PubMed 28695878
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Intestine Length Measurement Using 3D CT Volumetry and in Vivo Measurement Using Pre-marked Graspers in Revisional Bariatric Surgeries. A Comparative Study
- ClinicalTrials.gov ID
- NCT06696677
- Acronym / sponsor ID
- TSBL06052024
- Conditions
- Small Intestine Length
- Keywords
- Small bowel Length, reconstructed 3D CT scan, Revisions bariatric Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 26 Jan 2025 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 20 Nov 2024 (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.
Measuring bowel length during hypo-absorptive surgeries like Roux-en-Y gastric bypass (RYGB) and Single Anastomosis Duodeno-ileal Sleeve (SADI-s) is controversial and usually abandoned due to the high risk of intestinal injury. However, some surgeons, especially in revisional surgery, prefer to count the whole bowel length to avoid leaving very short segments and severe malnutrition afterwards.
3D reconstructed CT scan can be useful in such conditions, avoiding the risk of intestinal injury, but accurate measures might be doubtful.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This is a prospective cross-sectional analytic study designed to compare two methods of small bowel length measurement: preoperative 3D CT volumetry and intraoperative laparoscopic measurement using pre-marked graspers. The study will include adult patients undergoing revisional bariatric surgeries at Kasr AlAiny Hospitals. All participants will undergo preoperative imaging and intraoperative measurements, with results analyzed to determine the accuracy and correlation between the two methods.
| Arm | Type | Receives |
|---|---|---|
| Marked Laparoscopic graspers group | Active comparator | Procedure: Measuring the small instestine length using pre-marked laparoscopic graspersin this arm, the graspers will be marked by a sterile tape, 5 cm in length. This will help for accurate measuring of the whole intestine. |
| 3D CT scan group | Active comparator | Diagnostic Test: CTIn this arm, all patients involved in the study will have a pre-operative CT scan, for which a 3D reconstruction will be done and measure the whole small intestinal length. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are candidates for revisional bariatric surgery
- Patients consenting to participate in the study.
Key exclusion criteria (3 listed)
- Patients with severe adhesions where measuring the small bowel may expose them to unnecessary injuries.
- Patients refusing to participate in the study.
- Patient refusing CT scan to be done pre-operatively.
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 |
|---|---|---|
| CTCT measurment of small bowel | Diagnostic test | 3D CT scan group |
| Measuring the small instestine length using pre-marked laparoscopic graspersIntra-operatively, the surgeon will assess the length of the small intestine using a 5-cm marked laparoscopic graspers to accurately assess the whole small intestine length. | Procedure or surgery | Marked Laparoscopic graspers group |
Primary outcome
Accurate small bowel length
Time frame: about 6 months
the aim of the study to assess if the CT scan with 3D reconstruction will give accurate measures for the bowel length compared to the marked graspers used in laparoscopic surgery
2 secondary outcomes
Operative time
Time frame: intraoperative
Intestinal Injury
Time frame: up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Background: PubMed 23900506Massalou D, Bege T, Bourgouin S, Mancini J, Masson C, Baque P, Berdah SV. Three-dimensional variability of the mesentery and the superior mesenteric artery: application to virtual trauma modeling. Surg Radiol Anat. 2014 May;36(4):401-8. doi: 10.1007/s00276-013-1178-1. Epub 2013 Jul 31.
- Background: PubMed 30501957Zorrilla-Nunez LF, Campbell A, Giambartolomei G, Lo Menzo E, Szomstein S, Rosenthal RJ. The importance of the biliopancreatic limb length in gastric bypass: A systematic review. Surg Obes Relat Dis. 2019 Jan;15(1):43-49. doi: 10.1016/j.soard.2018.10.013. Epub 2018 Oct 22.
- Background: PubMed 30032419Ahuja A, Tantia O, Goyal G, Chaudhuri T, Khanna S, Poddar A, Gupta S, Majumdar K. MGB-OAGB: Effect of Biliopancreatic Limb Length on Nutritional Deficiency, Weight Loss, and Comorbidity Resolution. Obes Surg. 2018 Nov;28(11):3439-3445. doi: 10.1007/s11695-018-3405-7.
- Background: PubMed 28695878Mahawar KK, Parmar C, Carr WRJ, Jennings N, Schroeder N, Small PK. Impact of biliopancreatic limb length on severe protein-calorie malnutrition requiring revisional surgery after one anastomosis (mini) gastric bypass. J Minim Access Surg. 2018 Jan-Mar;14(1):37-43. doi: 10.4103/jmas.JMAS_198_16.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT and Measuring the small instestine length using pre-marked laparoscopic graspers in people with Small Intestine Length, run by Kasr El Aini Hospital at 2 sites in Egypt.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Mohammed Abdelsalam, MD, MRCS (+201111577188, a.abd.elsalam@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accurate small bowel length (time frame: about 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06696677, which also lists 4 linked publications.
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 28 Jan 2025.