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

Study Overview

• Status: Recruiting
• Conditions: Small Intestine Length
• Intervention / Treatment: Procedure: Measuring the small instestine length using pre-marked laparoscopic graspers; Diagnostic test: CT

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Mohammed Abdelsalam, MD, MRCS; Phone Number: +201111577188; Email: a.abd.elsalam@kasralainy.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Not yet recruiting
    • Kasr Alainy Medical School, Cairo University
    • Contact: Ahmed Mohammed
  • Old Cairo
    • Cairo, Old Cairo, Egypt, 11956
      • Recruiting
      • Kasr Alainy Medical School, Cairo University
      • Contact: Maher M Fawzy, Doctorate; Phone Number: +201222166937; Email: kasralainyrec@kasralainy.edu.eg
      • Contact: Ahmed M Ghobashy
      • Contact: Tamer Elholiby
      • Contact: Ahmed M Abdellatif
      • Contact: Ahmed Y Khaled

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Active Comparator: 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.	Diagnostic test: CT; CT measurment of small bowel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	about 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	up to 6 months

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Helpful Links

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Study record dates

Study Major Dates

• Study Start (Estimated): January 26, 2025
• Primary Completion (Estimated): July 30, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: October 5, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Actual): November 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 25, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Small bowel Length; reconstructed 3D CT scan; Revisions bariatric Surgery
• Other Study ID Numbers: TSBL06052024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No