Clinical trial NCT06696677: Small Intestine Length Measurement Using 3D CT Volumetry and in Vivo Measurement Using Pre-marked Graspers in Revisional Bariatric Surgeries. A Comparative Study
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Small Intestine Length
Keywords: Small bowel Length
reconstructed 3D CT scan
Revisions bariatric Surgery
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief 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. 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.


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.

Primary outcomes:
measure: Accurate small bowel length
timeFrame: about 6 months
Secondary outcomes:
measure: Operative time
timeFrame: intraoperative
measure: Intestinal Injury
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy Medical School, Cairo University
state: Old Cairo
city: Cairo
country: Egypt
facility: Kasr Alainy Medical School, Cairo University
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.