Recruiting

NCT Number: NCT06696677

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.

Recruiting

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Key information

Conditions

Small Intestine Length

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Alainy Medical School, Cairo University, Cairo, Old Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CT

Diagnostic Test

CT measurment of small bowel

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.

Primary outcomes

Accurate small bowel length

Time frame: about 6 months

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

Secondary outcomes

Operative time

Time frame: intraoperative

measuring the whole bowel length may increase the operative time according to the skills of the surgeon, the presence of adhesions, and short mesentery.
Intestinal Injury

Time frame: up to 6 months

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Mohammed Abdelsalam, MD, MRCS

CONTACT

[email protected]

+201111577188

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Nov 20, 2024
Registry last updated: Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.