Surgical Clinical Research Unit Projects

Projects undertaken by trainees and HSCRU in collaboration with the Hunter Medical Research  Insitute and the University of Newcastle are in a range of research designs and methodologies and include:

  • Investigator-initiated randomised trials
  • Co-operative study group randomised trials
  • Basic science
  • Retrospective cohort, audit and chart review
  • Biobanking and biomarkers
  • Meta-analysis and systematic reviews
  • Surveys and questionnaires

Research staff also support co-operative and sponsored trials especially in the area of cancer treatment, and work collaboratively with other clinical trial units in the HNE Clinical Cancer Research Network.

​Project name​Study DesignDescription
​BCG + Mitomycin Trial
​RCT​Adding mitomycin to BCG as adjuvant intravesical therapy for high-risk, non–muscle-invasive bladder cancer: a randomised phase 3 trial
​Masterplan​RCT​A study testing the impact of adding high dose RT to standard chemotherapy for the treatment of pancreatic cancer. This study is being led by the Australasian Gastro-intestinal Trials Group and is coordinated by the NHMRC Clinical Trials Centre Sydney. JHH and Calvary Mater Newcastle involved.
​Follow-up of Patients with Well-Differentiated Thyroid Cancer: a Survey of Clinician Preferences ​Cross-sectional survey​Despite good survival rates, recurrence of thyroid cancer can occur many years and even decades after initial treatment. This has led to most thyroid cancer patients being followed up for many years (minimum of five years) and in some cases for life.
​Evaluating Quality of Life Assessment Tools
in Patients Undergoing Thyroid Surgery
​Cross-sectional survey​Research into the quality of life of people undergoing thyroid surgery. This study is about better understanding patient’s experiences and the impact a diagnosis could have on daily life.
​A Randomised, Blinded Clinical Trial of Scalpel vs Electrocautery Skin Incisions in Participants undergoing Thyroid Surgery.​RCT​An RCT to compare cosmesis and wound healing
Mitochondrial Density and Function in Parathyroid Disease ​Biomarker studyTo describe the mitochondrial mass and activity found in parathyroid adenoma, hyperplasia and normal parathyroid tissue.
Closed vs Open Laparotomy for Severe Complicated intra-abdominal sepsis. COOL Study
​International Cooperative Group RCT
​A study comparing open (with negative pressure vacuum device) vs closed abominal mortality.
​Melatonin to improve sleep patients undergoing major abdominal surgery​Investigator-initiated Phase III RCT
​This project compares a sublingual dose of melatonin to placebo to investigate if it improves sleep whilst in hospital, based on a patient-reported outcome measure.
​Post-banding of Haemorrhoids Topical Analgesia​Investigator-initiated Phase III RCT​This project compares 3 topical ointments for post-procedure analgesia.
The Newcastle Skin Prep Study​Investigator-initiated Phase III RCT​This project is a large RCT comparing 3 standard skin disinfectants used for skin preparation in incisional surgery. Recruitment was completed late in 2018 and results are to be published shortly.
​Quality of Life After Thyroid Disease​Cross-sectional surveyThis study will be used to assess the self-reported quality of life of thyroid cancer survivors compared to that of patients who have had thyroid surgery or radioiodine ablation for benign disease, and patients who have been investigated for a potential thyroid malignancy.
CAPPS Study​Investigator-initiated Phase I study​A  study to investigate the safety and tolerability of 2 medicinal cannabis agents in surgical patients.

CRP Trajectory in Colorectal Resections

​​Investigator-initiated ​prospective observationalA multisite study to validate the uility of CRP trajectory as a predictor of anastomotic leak in colorectal resections.
​PIMCO Study​​Investigator-initiated prospective observationalA comparison of perioperative inflammatory markers and their relationship tp sepsis and surgical outcomes in colorectla cancer.
​LICPIC Study​Investigator-initiated Phase III RCT​Lignocaine in Laparoscopic Colorectal Surgery and effect on Natural Killer Cells
​SEST Study​Investigator-initiated Phase III RCT​A study comparing diathermy versus scalpel for thyroid surgery incision.
​Wound Bacteriology​Investigator-initiated prospective observational​A study to identify and characterise pathogens in colorectal surgical incisions at time of operation.
​Microleaks​Investigator-initiated prospective observational​A study looking at identifying pathogens at the site of bowel anastomoses.

​A La CaRT

PMID: 26441180 10.1001/jama.2015.12009

Co​-operative Group Phase III RCTAustralian Laparoscopic Cancer of the Rectum Trial. A Phase III Prospective Randomised Trial Comparing Laparoscopic-assisted Resection versus Open Resection for Rectal Cancer
​DOCTOR STUDY​Co​-operative Group Phase II RCT​A trial of pre-operative cisplatin, 5 fluorouracil and docetaxel A ± radiotherapy based on poor early response to standard chemotherapy for resectable adenocarcinoma of the oesophagus and/or OG Junction

​VIDIT Study

PMID:30387163
DOI:10.1111/cen.13897
​​Investigator-initiated Phase III RCT​A Double-Blind, Randomised, Placebo-controlled Trial to Assess the Efficacy of Preoperative Oral Cholecalciferol, versus Placebo at Preventing Postoperative Hypocalcaemia in Patients Undergoing Total Thyroidectomy

​LAPLAP Study

PMID:31120614
DOI:10.1111/codi.14720
​​​Investigator-initiated Phase III RCT​A double-blinded, randomized, placebo-controlled clinical trial assessing postoperative recovery using intraperitoneal local anaesthetic in laparoscopic colorectal surgery.

​Procalcitonin Study

PMID:28304142
DOI:10.1111/ans.13937
​Investigator-initiated prospective observational​Procalcitonin as a Marker of Anastomotic Leak - An Observational Study.

CRP in Acute Appendicitis

PMID: 30309747
DOI:10.1016/j.surge.2018.08.007
​Investigator-initiated prospective observational​A Prospective Observational Study of CRP Velocity in Suspected Acute Appendicitis
​Liver Biopsies​​Investigator-initiated restroprospective review​The futility of FNA and CNB in the management of patients with solid liver lesions

​ABBI Study

PMID: 29265566

10.1111/ans.14317

​​​​Investigator-initiated Phase III RCT​Trial to Assess the Efficacy of Bolus Versus Infusion as a Mode of Delivery for Local Anaesthetic Blocks Following Abdominal Surgery