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

NCT06036641 | Completed

• 2 other identifiers: IRAS [287464]CPMS ID - 56254
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Compartment Syndrome Nontraumatic Lower Extremity

Keywords

Head Down Tilt Lithotomy; Minimally Invasive Surgery; Ischaemia Reperfusion Syndrome; Pathophysiology; Near Infrared Spectroscopy, NIRS; Robotic Assisted Laparoscopic Surgery; Well leg Compartment Syndrome

Outcome Measures

Primary Outcomes (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.

  baseline, during the surgery

Secondary Outcomes (10)

• Muscle tissue oxygenation

  baseline, during the surgery

• Plasma interleukin-6 (IL-6) concentration

  baseline, during the surgery

• Plasma Tumour Necrosis Factor Alpha (TNF-α) concentration

  baseline, during the surgery

• Plasma Superoxide Dismutase (SOD) concentration

  baseline, during the surgery

• Plasma Protein Carbonyl concentration

  baseline, during the surgery

Study Arms (1)

Colorectal surgery

Individuals scheduled for colorectal surgery in the HDTL position

Device: NIRS monitoring; Device: Laser Doppler flowmetry; Other: Inflammatory and Oxidative stress biomarkers

Interventions

NIRS monitoring DEVICE

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

Colorectal surgery

Laser Doppler flowmetry DEVICE

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

Colorectal surgery

Inflammatory and Oxidative stress biomarkers OTHER

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

Colorectal surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Adults scheduled to undergo colorectal surgery in the HDTL position

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Portsmouth: lead
• Portsmouth Hospitals NHS Trust: collaborator

Study Sites (1)

Queen Alexandra Hospital, Portsmouth Hospitals University NHS Trust

Portsmouth, West Sussex, PO6 3LY, United Kingdom

Location

MeSH Terms

Interventions

Laser-Doppler Flowmetry

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Rheology; Investigative Techniques

Study Officials

• Chukwuemeka C Uzoma, MBBS

  University of Portsmouth

  PRINCIPAL INVESTIGATOR

• Maria C Perissiou, PhD

  University of Portsmouth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: September 3, 2023
• First Posted: September 14, 2023
• Study Start: July 22, 2024
• Primary Completion: November 3, 2025
• Study Completion: November 3, 2025
• Last Updated: May 1, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)