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Compartment Syndrome Nontraumatic Lower ExtremityHELPNCT06036641

The Effects of Prolonged Head-Down Tilt Lithotomy Position on Lower Limb Haemodynamics

An observational study of Compartment Syndrome Nontraumatic Lower Extremity, run by University of Portsmouth at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

During certain bowel surgeries for cancer (colorectal surgery), individuals frequently have to be placed in a head-down position to enable surgeons have optimal access to the cancer site. This position usually also involves bending the hips and knees while supporting the legs in stirrups. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NIRS monitoring, Laser Doppler flowmetry and Inflammatory and Oxidative stress biomarkers
Type of treatment
Medical device
How many people
26 participants
Where
1 siteUnited Kingdom
Study dates
22 Jul 2024to 3 Nov 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult individuals(18 years and above) scheduled to undergo surgery in the HDTL position at the Department of Colorectal Surgery, Queen Alexandra Hospital, Portsmouth Hospitals University NHS Trust.

Who may be able to join

  • Adults scheduled to undergo colorectal surgery in the HDTL position

Who cannot join

  • History of myocardial infarction or cerebro-vascular events in the last 12 months
  • Previous revascularisation procedure in their lower limbs
  • BMI > 40 kg/m2
  • Inability to give informed consent
  • Other serious medical conditions, which in the opinion of study investigators, would interfere with safety or data interpretation

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Queen Alexandra Hospital, Portsmouth Hospitals University NHS Trust

    Portsmouth, West Sussex, PO6 3LY

Other trials in United Kingdom

About this study

Official title: The Effects of Prolonged Head-Down Tilt Lithotomy Position on Lower Limb Haemodynamics in Adults Undergoing Minimally Invasive Abdominopelvic Surgery: An Intraoperative Observational Study

During certain bowel surgeries for cancer (colorectal surgery), individuals frequently have to be placed in a head-down position to enable surgeons have optimal access to the cancer site. This position usually also involves bending the hips and knees while supporting the legs in stirrups. However, lying in this position for long periods of time can lower the flow of blood to the legs, which can potentially cause injury. This rare but severe consequence is called Well-Leg Compartment Syndrome (WLCS). If WLCS is not diagnosed quickly, it can lead to other difficult complications and a significant delay in recovery. Unfortunately, because the individual is under anaesthesia, diagnosis is delayed in many cases. There is very little information in the medical literature about how this damage to the legs progresses over the course of the surgery. To better understand how WLCS, how well blood vessels work during surgery will be assessed. The flow of blood and oxygen in the calf muscle will be assessed in 25 individuals placed in a head-down position during colorectal surgery. Likewise, blood samples will be obtained in order to measure the biological markers that may contribute to the development of WLCS.

Read the detailed description

The development of lower limb compartment syndrome in the absence of trauma (known as well-leg compartment syndrome, WLCS) is a severe complication reported during prolonged pelvic surgery. WLCS is characterised by muscular ischaemia and secondary necrosis from the increase in hydrostatic pressure in a closed fascial compartment.

The aetiology of WLCS appears to be primarily related to ischaemia of the lower limbs after a prolonged period in the head-down tilt lithotomy (HDTL) position, which is commonly used to access the pelvis and perineum during urological, colorectal, and gynaecological surgery. Elevation of the lower limbs above the heart results in a ~2 mmHg drop in mean arterial pressure at the mid-calf for every 2.5 cm that the limbs are raised. These hemodynamic changes are accompanied by an increase in compartment pressures associated with limb elevation and are further exacerbated by a steep (>15°) head-down tilt. The outcome of these changes ultimately leads to the development of significant and (often unrecognised) intraoperative ischemia in the lower limbs.

Prolonged reductions in lower limb perfusion during HDTL can cause the development of localised tissue oedema, leading to marked intracompartmental hypertension, which is further exacerbated once the limbs are lowered and reperfusion of ischemic muscle occurs. This is a consequence known as ischaemic-reperfusion injury (IRI), a phenomenon where reperfusion per se may result in a local and systemic inflammatory response that may augment tissue injury in excess of that produced by ischaemia alone.

Microvascular injury is considered one of the major determinants of IRI, particularly due to increased permeability of capillaries and arterioles that lead to an increase in diffusion and fluid filtration across the tissues. Subsequently, activated endothelial cells produce more reactive oxygen species and less nitric oxide, and this imbalance results in a corresponding inflammatory response and increased oxidative stress, which if sufficiently severe lead to further lower limb muscle and nerve injury.

The incidence of WLCS is unpredictable and as the individual is anaesthetised, the diagnosis is delayed in many cases, so the residual motor-sensory deficit may be severe, even after fasciotomy. Although there are many published case reports of this condition, it is likely that many cases of WLCS go unreported, and some may be mild and escape clinical detection. However, in cases that have been reported, the incidence of permanent disability after the development of WLCS ranges from ≈30% to ≈100%.

The paucity of detailed observational studies into the effects of HDTL on lower limb haemodynamics and tissue oxygenation has restricted the ability of the clinical and scientific society to construct clinical strategies to minimise this complication. Identifying individuals with risk factors and increasing surveillance during surgery in these people may allow for early detection and decrease the morbidity and potential mortality associated with intraoperative WLCS.

The study aims to assess lower limb haemodynamics by measuring cutaneous blood flow, muscle and brain tissue oxygenation, inflammatory and oxidative stress biomarkers during pelvic surgery in patients placed in HDTL. This study has the potential to provide a better understanding of the pathogenesis of WLCS and add novel knowledge regarding its early diagnosis.

Being tested
NIRS monitoring, Laser Doppler flowmetry, Inflammatory and Oxidative stress biomarkers
Keywords
Head Down Tilt Lithotomy, Minimally Invasive Surgery, Ischaemia Reperfusion Syndrome, Pathophysiology, Near Infrared Spectroscopy, NIRS, Robotic Assisted Laparoscopic Surgery, Well leg Compartment Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NIRS monitoringDevice

    All participants will undergo NIRS monitoring of muscle and cerebral tissue oxygenation intraoperatively.

  • Laser Doppler flowmetryDevice

    Cutaneous blood flow will be assessed intraoperatively via Laser Doppler flowmetry in all participants

  • Inflammatory and Oxidative stress biomarkersOther

    Blood samples will be taken to measure biomarkers of inflammation and oxidative stress at specific time points

Study groups in NCT06036641
Study groupRoleWhat they receive
Colorectal surgeryIndividuals scheduled for colorectal surgery in the HDTL position
Receives: Device: NIRS monitoring; Device: Laser Doppler flowmetry; Other: Inflammatory and Oxidative stress biomarkers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cutaneous blood flow

    Change over time in cutaneous blood flow in the legs relative to a vascular occlusion test (VOT) during surgery in the HDTL position.

    Measured: baseline, during the surgery

Secondary outcomes (10)
  1. Muscle tissue oxygenation

    Change over time in muscle tissue oxygenation in the lower limb relative to a vascular occlusion test (VOT) during surgery in the HDTL position.

    Measured: baseline, during the surgery

  2. Plasma interleukin-6 (IL-6) concentration

    Change over time in [IL-6] during surgery in the HDTL position.

    Measured: baseline, during the surgery

  3. Plasma Tumour Necrosis Factor Alpha (TNF-α) concentration

    Change over time in [TNF-α] during surgery in the HDTL position.

    Measured: baseline, during the surgery

  4. Plasma Superoxide Dismutase (SOD) concentration

    Change over time in [SOD] during surgery in the HDTL position.

    Measured: baseline, during the surgery

  5. Plasma Protein Carbonyl concentration

    Change over time in [protein carbonyl] during surgery in the HDTL position.

    Measured: baseline, during the surgery

  6. Plasma nitrate concentration

    Change over time in [nitrate] during surgery in the HDTL position.

    Measured: baseline, during the surgery

  7. Plasma nitrite concentration

    Change over time in [nitrite] during surgery in the HDTL position.

    Measured: baseline, during the surgery

  8. Mean arterial pressure (MAP)

    Change over time in MAP during surgery in the HDTL position.

    Measured: baseline, during the surgery

  9. Skin temperature

    Change over time in skin temperature during surgery in the HDTL position.

    Measured: baseline, during the surgery

  10. Brain tissue oxygenation

    Change over time in brain tissue oxygenation during surgery in the HDTL position.

    Measured: continuous measurement during the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2023
  2. Study start22 Jul 2024
  3. Primary completion3 Nov 2025
  4. Study completion3 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06036641
Sponsor's protocol ID
IRAS [287464]
Other IDs
CPMS ID - 56254
Acronym
HELP
Status last verified
Nov 2025
First submitted
3 Sep 2023
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Compartment Syndrome Nontraumatic Lower Extremity, run by University of Portsmouth at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cutaneous blood flow (time frame: baseline, during the surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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