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.
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
- Conditions the study is for
- Compartment Syndrome Nontraumatic Lower Extremity
- 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
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 group | Role | What they receive |
|---|---|---|
| Colorectal surgery | Individuals 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.
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)
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
Plasma interleukin-6 (IL-6) concentration
Change over time in [IL-6] during surgery in the HDTL position.
Measured: baseline, during the surgery
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
Plasma Superoxide Dismutase (SOD) concentration
Change over time in [SOD] during surgery in the HDTL position.
Measured: baseline, during the surgery
Plasma Protein Carbonyl concentration
Change over time in [protein carbonyl] during surgery in the HDTL position.
Measured: baseline, during the surgery
Plasma nitrate concentration
Change over time in [nitrate] during surgery in the HDTL position.
Measured: baseline, during the surgery
Plasma nitrite concentration
Change over time in [nitrite] during surgery in the HDTL position.
Measured: baseline, during the surgery
Mean arterial pressure (MAP)
Change over time in MAP during surgery in the HDTL position.
Measured: baseline, during the surgery
Skin temperature
Change over time in skin temperature during surgery in the HDTL position.
Measured: baseline, during the surgery
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.
- First posted14 Sep 2023
- Study start22 Jul 2024
- Primary completion3 Nov 2025
- Study completion3 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compartment Syndrome Nontraumatic Lower ExtremityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Portsmouth
- Sponsor type
- University, hospital or other
- Collaborators
- Portsmouth Hospitals NHS Trust
- Responsible party
- Principal investigator, Maria Perissiou, University of Portsmouth
- Investigators
- Chukwuemeka C Uzoma, MBBS, Principal investigator, University of PortsmouthMaria C Perissiou, PhD, Principal investigator, University of Portsmouth
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
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06036641
- Acronym / sponsor ID
- HELP / IRAS [287464]
- Keywords
- Head Down Tilt Lithotomy, Minimally Invasive Surgery, Ischaemia Reperfusion Syndrome, Pathophysiology, Near Infrared Spectroscopy, NIRS, Robotic Assisted Laparoscopic Surgery, Well leg Compartment Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of PortsmouthUniversity, hospital or other
- Collaborators
- Portsmouth Hospitals NHS Trust
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 3 Nov 2025 (actual)
- Study completion
- 3 Nov 2025 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal surgery | – | Device: NIRS monitoring, Device: Laser Doppler flowmetry, Other: Inflammatory and Oxidative stress biomarkersIndividuals scheduled for colorectal surgery in the HDTL position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Adults scheduled to undergo colorectal surgery in the HDTL position
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIRS monitoringAll participants will undergo NIRS monitoring of muscle and cerebral tissue oxygenation intraoperatively. | Device | Colorectal surgery |
| Laser Doppler flowmetryCutaneous blood flow will be assessed intraoperatively via Laser Doppler flowmetry in all participants | Device | Colorectal surgery |
| Inflammatory and Oxidative stress biomarkersBlood samples will be taken to measure biomarkers of inflammation and oxidative stress at specific time points | Other | Colorectal surgery |
Primary outcome
Cutaneous blood flow
Time frame: baseline, during the surgery
Change over time in cutaneous blood flow in the legs relative to a vascular occlusion test (VOT) during surgery in the HDTL position.
10 secondary outcomes
Muscle tissue oxygenation
Time frame: baseline, during the surgery
Plasma interleukin-6 (IL-6) concentration
Time frame: baseline, during the surgery
Plasma Tumour Necrosis Factor Alpha (TNF-α) concentration
Time frame: baseline, during the surgery
Plasma Superoxide Dismutase (SOD) concentration
Time frame: baseline, during the surgery
Plasma Protein Carbonyl concentration
Time frame: baseline, during the surgery
Plasma nitrate concentration
Time frame: baseline, during the surgery
Plasma nitrite concentration
Time frame: baseline, during the surgery
Mean arterial pressure (MAP)
Time frame: baseline, during the surgery
Skin temperature
Time frame: baseline, during the surgery
Brain tissue oxygenation
Time frame: continuous measurement during the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chukwuemeka C Uzoma, MBBS principal investigator
University of Portsmouth
Maria C Perissiou, PhD principal investigator
University of Portsmouth
1 site in 1 country: see every site and its status.
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.