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

NCT06696677 | Recruiting DMC

• 1 other identifier: TSBL06052024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Small Intestine Length

Keywords

Small bowel Length; reconstructed 3D CT scan; Revisions bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Operative time

  intraoperative

• Intestinal Injury

  up to 6 months

Study Arms (2)

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.

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.

Diagnostic Test: CT

Interventions

CT DIAGNOSTIC_TEST

CT measurment of small bowel

3D CT scan group

Measuring the small instestine length using pre-marked laparoscopic graspers 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.

Marked Laparoscopic graspers group

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (2)

Kasr Alainy Medical School, Cairo University

Cairo, Old Cairo, 11956, Egypt

RECRUITING

Kasr Alainy Medical School, Cairo University

Cairo, Egypt

NOT YET RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• Related Info
• Related Info
• Related Info

Central Study Contacts

Ahmed Mohammed Abdelsalam, MD, MRCS

CONTACT

+201111577188; a.abd.elsalam@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: the investigator- the surgeon- will not be aware of the pre-operative measurements found in the CT scan, not to be biased in measuring.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of General Surgery

Model Details: 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.

Study Record Dates

• First Submitted: October 5, 2024
• First Posted: November 20, 2024
• Study Start: January 26, 2025
• Primary Completion: July 30, 2025
• Study Completion: July 31, 2025
• Last Updated: January 28, 2025

Record last verified: 2024-11

Locations

EG (2)