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Recruiting NCT06696677

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

No phase Interventional Small Intestine Length

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CT, Measuring the small instestine length using pre-marked laparoscopic graspers.
Who it may be relevant to
Registry conditions: Small Intestine Length. Basic parameters: 16 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Diagnostic test CT
    CT measurment of small bowel
  • Procedure 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.

Primary outcome measures

  • Accurate small bowel length [Time frame: about 6 months]
Secondary outcome measures (2)
  • Operative time [Time frame: intraoperative]
  • Intestinal Injury [Time frame: up to 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Single blind
Primary purpose
Diagnostic

Study locations

Egypt · 2 centers
  • Kasr Alainy Medical School, Cairo University — Cairo
  • Kasr Alainy Medical School, Cairo University — Cairo

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. PMID 23900506
  • 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. PMID 30501957
  • 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. PMID 30032419
  • 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. PMID 28695878

Identifiers

NCT: NCT06696677 · TSBL06052024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗