Small Intestine Length Measurement Using 3D CT Volumetry and in Vivo Measurement Using Pre-marked Graspers in Revisional Bariatric Surgeries. A Comparative Study

NCT ID: NCT06696677

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-26

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Small Intestine Length

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators
the investigator- the surgeon- will not be aware of the pre-operative measurements found in the CT scan, not to be biased in measuring.

Study Groups

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Marked Laparoscopic graspers group

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.

Group Type ACTIVE_COMPARATOR

Measuring the small instestine length using pre-marked laparoscopic graspers

Intervention Type PROCEDURE

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.

3D CT scan group

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.

Group Type ACTIVE_COMPARATOR

CT

Intervention Type DIAGNOSTIC_TEST

CT measurment of small bowel

Interventions

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CT

CT measurment of small bowel

Intervention Type DIAGNOSTIC_TEST

Measuring the small instestine length using pre-marked laparoscopic graspers

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients who are candidates for revisional bariatric surgery
* Patients consenting to participate in the study.

Exclusion Criteria

* 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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Abdelsalam M

Associate Professor of General Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kasr Alainy Medical School, Cairo University

Cairo, Old Cairo, Egypt

Site Status RECRUITING

Kasr Alainy Medical School, Cairo University

Cairo, , Egypt

Site Status NOT_YET_RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed Mohammed Abdelsalam, MD, MRCS

Role: CONTACT

+201111577188

Facility Contacts

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Maher M Fawzy, Doctorate

Role: primary

+201222166937

Ahmed Mohammed

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 23900506 (View on PubMed)

Zorrilla-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.

Reference Type BACKGROUND
PMID: 30501957 (View on PubMed)

Ahuja 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.

Reference Type BACKGROUND
PMID: 30032419 (View on PubMed)

Mahawar 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.

Reference Type BACKGROUND
PMID: 28695878 (View on PubMed)

Related Links

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Other Identifiers

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TSBL06052024

Identifier Type: -

Identifier Source: org_study_id

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