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Gastrointestinal ultrasound ileus study (GUILE)

The use of point of care ultrasound in detecting postoperative ileus in patients undergoing elective colorectal resection

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621001251819
Acronym
GUILE
Enrollment
31
Registered
2021-09-15
Start date
2022-04-06
Completion date
2023-04-14
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Colorectal cancer is a leading cause of cancer related mortality with surgery to remove the cancer the mainstay of treatment. This involves operating to remove a section of the bowel (“colorectal resection”). The recovery is very dependent on the bowel returning to a normal function. In up to one third of patients this can be delayed such that the patient cannot tolerate drink and food. They may feel nauseous, bloated or have no appetite. In some patients this can persist and become a major complication leading to a prolong hospital stay and putting them at risk of other complications like infection. The aim of the study is to use ultrasound at the bedside to monitor function of the bowel before and after surgery. Who is it for? You may be eligible for this study if you are an adult older than 18 years with colorectal cancer who is planned to undergo colorectal resection. Study details All participants will receive an ultrasound prior to the surgery, as well as at days 1 and 2 post-operatively. This involves placing a hand-held probe against the abdomen, similar to one used to look for a baby in a mother’s womb, 40-60 minutes prior to the scan, participants will drink 250 milliliters of water, so that activity of the bowel can be determined. If a poorly functioning bowel is identified, participants may receive additional scans on day 3 and 4 post operatively. It is hoped that this research will show that ultrasound is a useful method for detecting early impairment of bowel function, so that doctors can then prescribe treatments to support the patient. However, this study will only observe bowel function and is not intended to change your usual care after surgery.

Interventions

Participants (recruited patients presenting for elective colorectal resection) will undergo a series of ultrasound (US) scans whilst in hospital. These will occur in the anaesthetic room on the day of surgery and post operatively on the ward at times outlined in the US protocol below. They will be performed by a combination of anaesthetists, colo-rectal surgeons and ultrasonographers and last approximately 15minutes each. US scans will be performed in a fasted state and also after a fluid challe

Participants (recruited patients presenting for elective colorectal resection) will undergo a series of ultrasound (US) scans whilst in hospital. These will occur in the anaesthetic room on the day of surgery and post operatively on the ward at times outlined in the US protocol below. They will be performed by a combination of anaesthetists, colo-rectal surgeons and ultrasonographers and last approximately 15minutes each. US scans will be performed in a fasted state and also after a fluid challenge which involves scanning the gastric antrum at 40 minutes after oral ingestion of 250mls water. If there is lack of gastric emptying at 40 minutes, a further scan will be performed at 60 minutes post ingestion of water. Standardised US Protocol 1. Gastric Antrum: Using a portable US machine (low-frequency probe) subjects will be placed in the right lateral decubitus position. Imaging is in the epigastric region in a parasagittal orientation. The cross-sectional area of the gastric antrum is measured and the gastric volume calculated. 2. Terminal Ileum (Resource and skill set dependent*, exploratory imaging): Using a low-frequency probe, the distal ileum will be located, the luminal diameter and wall thickness measured. In addition, peristaltic waves in the terminal ileum, which will be categorised as absent, normal or dysfunctional. 3. US timepoints: Day 0 (Preoperatively) - Fasted gastric antrum US Postoperative Day 2: i. Fasted US with fluid challenge (7-9am). Baseline and at 40-60mins ii. Spot US (2-4pm). Baseline and 40-60mins post fluid challenge Postoperative Day 1: Resource dependent scanning only (fasted and with fluid challenge) Postoperative Days 3 and 4: Selective scanning only in those who have demonstrated delayed gastric emptying or have not re-established a full diet. No further scanning will occur after post operative day 4. *Note: Resource dependent scanning will not involve a separate cohort and will be available to all enrolled participants depending on availability of equipment and appropriately skilled personnel to perform scans. Oral intake and the incidence of major complications (Clavien-Dindo classification III -V) up to 30 days post operatively will be obtained by assessment of patient medical records.

Sponsors

St Vincent's Hospital Melbourne
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All patients undergoing elective colorectal resection (Although this will predominantly involve participants undergoing colorectal resection for the treatment of colorectal cancer we are also including non cancer surgery including inflammatory bowel disease).

Exclusion criteria

Any patient unwilling or unable to give consent Any patient who is currently pregnant or has been pregnant in the last 3 month period Any patient who has undergone previous upper gastro intestinal tract surgery or has distorted upper gastrointestinal tract anatomy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026