Evaluation of Surgical Effectiveness

Surgery versus stent insertion for the management of non-curable large bowel obstruction

Christopher Young1, Michael Solomon, Frank Frizelle2, Ian Faragher3, Jane Young, Brian Draganic4, Stephen Smith4, Anil Keshava5, Pierre Chapuis5, Matthew Rickard5, Christine Merlino1, Robyn Secomb1

  1. Department of Colorectal Surgery, Royal Prince Alfred Hospital
  2. Department of Surgery, Christchurch Hospital, New Zealand
  3. Division of Surgery, Western Hospital, Victoria
  4. Department of Colorectal Surgery, John Hunter Hospital, Newcastle
  5. Department of Colorectal Surgery, Concord Repatriation General Hospital

For patients with a malignant bowel obstruction that cannot be cured, management to relieve the obstruction usually involves surgery to resect a part of the large bowel and formation of a stoma where the bowel is brought to the surface of the skin. An alternative to this major surgery is the placement of a metal stent via colonoscopy, through the obstruction to allow the passage of faecal matter. As both of these interventions are palliative, the most important outcomes are those relating to Quality of Life.

This study aims to determine whether patients’ Quality of Life is greater following stent insertion. An economic evaluation will determine the relative cost-effectiveness of the two procedures. Ethics approval has been granted in 5 sites in Australasia.

Status: Recruitment complete. Follow-up underway.


Audit of patient participation in colorectal cancer surgical research

Michael Solomon, Jane Young, Rosemary Smith, Emily Chew1

  1. Department of Colorectal Surgery, Royal Prince Alfred Hospital

This is an ongoing audit commenced from January 2009 to determine the proportion of colorectal cancer surgical patients involved in one or more research projects. This audit will also help identify any associations between research participation and patient characteristics. The research database will help monitor research activity within the department and provide statistical information that will demonstrate any gaps and will help with future planning of patient recruitment.

Status: Audit underway.


A randomised control trial examining the effect of preoperative carbohydrate loading on incidence of infectious complications after surgery within an enhanced recovery protocol

Michael Solomon, Ewan MacDermid, Mark Hayman1, Jane Young

  1. Department of Anaesthesia, Royal Prince Alfred hospital

While Enhanced Recovery After Surgery (ERAS, or “fast-track”) protocols have been shown to improve a variety of patient outcomes, including a reduction in length of hospital stay, considerable debate about the relative impact and value of individual interventions continues. One component of ERAS, carbohydrate loading, has not been tested rigorously to assess any effect it may have on incidence of post-operative infection.

All eligible patients undergoing colorectal, gynae-oncological or hepatic resection will be approached for study inclusion. Patients will be randomised to either an ERAS protocol with carbohydrate loading the the form of a carbohydrate-rich beverage (Nutricia PreOpTM, 400 mls evening before and 200mls three hours before surgery), or ERAS alone. Primary outcome measures shall include incidence of infectious complications including wound, urinary tract and pulmonary infection, as well as all other complications. Secondary outcome measures shall include length of hospital stay, time until return of bowel function, time until return to independent mobilisation and length of hospital stay.

Status: A proposal for ethical approval for a pilot study is currently in progress


An algorithm for the management of thoracic and abdominal aortic aneurysms

Andrew G Sherrah1, Paul G Bannon2

  1. The Baird Institute
  2. Department of Cardiology, Royal Prince Alfred Hospital

This study is a review of the professional opinion of specialists involved in the monitoring and management of thoracic aortic aneurysms (TAA) and/or abdominal aortic aneurysms (AAA). The results of this are compared with and evaluated against the current literature concerning TAA and AAA treatment and management, with the intention of providing suitable recommendations for the potential development of a TAA/AAA management algorithm.

A self-administered questionnaire was mailed to specialists from the departments of Cardiothoracic Surgery, Vascular Surgery, Vascular Medicine, Cardiology and Radiology at two tertiary teaching hospitals. In general, both clinicians and the published literature agreed upon the most beneficial imaging modality for TAA/AAA. The most appropriate intervention points with regards to aneurysm size were overall concordant between surveyed clinicians and published literature, with some tendency for the clinicians to intervene earlier. There was some discrepancy between clinicians and published literature regarding most appropriate TAA/AAA intervention in emergency settings. Regarding TAA/AAA, recommendations in the literature may or may not be utilised by treating clinicians. Nonetheless, recommendations for a TAA/AAA management algorithm are made from the current results that reflect both evidence-based practice and the practicalities and limitations faced by the treating clinician.

Status: Manuscript in preparation


Quality of life outcomes and cost effectiveness of patients with pelvic cancer: a prospective study

Michael Solomon, Jane Young, Kirk Austin1, Christopher Byrne1, Peter Lee1, Alexander Heriot2, Frank Frizelle3, Glenn Salkeld, Madeleine King4, Rosemary Smith, Emily Chew1

  1. Department of Colorectal Surgery, Royal Prince Alfred Hospital
  2. Peter MacCallum Cancer Institute/St Vincent’s Hospital, Melbourne
  3. Department of Surgery, Christchurch Hospital, New Zealand
  4. Psycho-oncology Co-operative Research Group (PoCoG), School of Psychology, University of Sydney

This study involves two groups of patients, those with locally advanced primary and recurrent pelvic cancer with no evidence of metastatic disease and those patients who do are assessed for pelvic exenteration but do not proceed with the procedure.

Pelvic exenteration involves the removal of the entire pelvic contents as well as some of the bony pelvis. It is a complex surgery and carries substantial morbidity and mortality risks. At present there is little information regarding the patient’s quality of life outcomes after this procedure. The information collected will compare clinical and quality of life outcomes between these two groups. The information collected will be important to those clinicians and to the patients themselves facing the decision regarding treatment options.

All patients once consented into the study are asked to complete a quality of life questionnaire. These questionnaires are then repeated at five time points during the following twelve months. Information is also obtained during this time to ascertain an evaluation of health services utilisation which will assist in the economic analysis of the procedure which will be invaluable to healthcare and policy planning.

Numbers so far recruited into study at Royal Prince Alfred Hospital include 126 patients. The second site at The Peter MacCallum Cancer Centre in Melbourne has commenced recruitment with 20 patients recruited so far.

Status: Recruitment and follow-up underway.


A La CaRT: Australasian phase III randomised trial comparing laparoscopic assisted versus open resection for rectal cancer

Andrew Stevenson1, Michael Solomon, Christopher Byrne2, Christopher Lee1, Anthony Eyres1

  1. Royal Brisbane and Women's Hospital Queensland
  2. Department of Colorectal Surgery, Royal Prince Alfred Hospital

This study is sponsored by the Australasian Gastro-Intestinal Trial Group and is a phase III prospective randomised trial comparing laparoscopic-assisted resection versus open resection for rectal cancer.

This study will be to determine whether laparoscopic assisted resection is not inferior to open rectal resection as a safe effective oncologic approach to rectal cancer and to determine whether the laparoscopic resection is not inferior to open resection in relation to morbidity and mortality which is associated with surgery, disease free survival and disease recurrence and quality of life.

Recruitment commenced in 2010 and so far there have been 20 patients recruited to the study at Royal Prince Alfred Hospital.

Status: Recruitment underway


Urological leaks after pelvic exenteration

Suzana Teixeira1, Floris Ferenschild2, Michael Solomon, Laura Rodwell, James Harrison, Jane Young, Arthur Vasilaras3, David Eisinger3, Peter Lee2, Christopher Byrne2

  1. ErasmusMC, Rotterdam
  2. Department of Colorectal Sugery, Royal Prince Alfred Hospital
  3. Department of Urology, Royal Prince Alfred Hospital

The aim of this study was to assess possible risk factors for urinary leakage of a newly formed urinary conduit after a partial or total pelvic exenteration. An analysis was conducted from prospectively collected data of patients who underwent a pelvic exenteration with conduit formation for advanced and recurrent pelvic cancer.

Of 232 patients undergoing a pelvic exenteration, 74 (32%) had a conduit formed. Of these, 47 (64%) had an ileal conduit compared with 27 (36%) a colonic conduit. Twelve (16%) patients developed a leak, of which nine occurred within the first month. Factors associated with a conduit leak included involvement of R2 surgical margins (43%), the magnitude of the exenteration and a current cardiovascular medical history (27%). Leaks were not found to be associated with either chemotherapy or radiotherapy. The 30-day leak rate for ileal conduits was 17% (8/47) and 4% (1/27) for colonic conduits with enterocutaneous fistula only occurring in the ileal conduit group (2/47). Fistula, drained collections and sepsis occurred in 40% of ileal and 19% of colonic conduits (p<0.01). Patients with a conduit leak had a longer length of stay (59 versus 23 days, p<0.001).

Urine leaks after conduit formation in association with exenterations are relatively common with a prolonged length of hospital stay. Cardiovascular risk factors, positive surgical margins and exenterations involving all four quadrants of the pelvis were associated with higher leak rates. There was no evidence of a difference between ileal and colonic conduits and number of leaks. However colonic conduits had less sepsis and pelvic collections including comparatively no complications of a small bowel fistula.

Status: In Press, European Journal of Surgical Oncology


The effect of anastomotic technique on surgical recurrence rates in Crohn’s disease - A NSW data linkage study

Kelvin Kwok1, Laura Rodwell, Jane Young, Michael Solomon

  1. Master of Surgery student, University of Sydney

The peak age of onset of Crohn’s disease (CD) is between the second to fourth decades of life. The majority of CD patients will require a bowel resection during their lifetime, with 30 to 55% requiring a second operation for CD recurrence, or surgical recurrence (SR) within 10 years. Accurate long-term follow-up is difficult to acquire due to the mobile patient demographic.

To examine the impact of anastomotic technique in CD on SR rates, using data linkage techniques to identify additional SR performed outside of the study centres.

Patients undergoing initial bowel resection and anastomosis for CD from 1996 to 2008 at Royal Prince Alfred Hospital, Gosford and Wyong Hospitals were retrospectively reviewed. Data linkage of this cohort with the NSW Admitted Patients Data Collection and the Registry of Births Deaths and Marriages deaths records was conducted by the Centre for Health Record Linkage. Procedural codes were used to identify SR performed for CD. Survival analysis was performed to assess differences between anastomotic technique and the time to first SR.

Of 105 eligible patients, 13 had at least one SR (12%). 5 of 22 hand-sewn anastomoses (23%) compared with 8 of 83 stapled anastomoses (10%) developed SRs, (mean follow-up: 7.8 vs 5.3years respectively). 4 of 21 end-to-end anastomoses (19%) compared with 9 of 84 side-to-side anastomoses (11%) developed SRs (mean follow-up: 7.7 vs 5.3years respectively). Survival analysis did not demonstrate any significant difference in SR between anastomotic techniques (Log-rank test, p>0.5).

After accounting for the differences in follow-up, anastomotic technique does not seem to be a predictor of SR.

Status: Manuscript in preparation


Wound outcomes after pelvic exenteration surgery in patients requiring myocutaneous flap reconstruction

Anita Jacombs1, Philip Rome2, James Harrison, Michael Solomon

  1. Macquarie University
  2. Department of Plastic Surgery, Royal Prince Alfred Hospital

Pelvic exenteration is increasingly used for surgical management of locally advanced/recurrent pelvic malignancy. Improved peri-operative management has reduced post-operative mortality (<5%-10%). Surgical morbidity, however, remains high (>50%) with wound complications common. Myocutaneous flaps (MCF) are increasing used to reconstruct the pelvic defects with the aim of improving wound outcomes. We have retrospectively reviewed the peri-operative morbidity and wound outcomes in pelvic exenteration patients.

All patients undergoing pelvic exenteration surgery from 1994-2011 at RPAH were reviewed. The sample was categorised into two groups relating to closure; 1) MCF or 2) primary closure (PC) for analysis of pre-operative characteristics; operative outcomes and peri-operative complications for statistical analysis.

202 patients were reviewed, 40 MCF and 162 PC. MCF patients had significantly (p<0.05) higher: rates of recurrent disease (85% v 55%); total exenteration (87% v 33%); mean operative times (669.28min v 379.63min); blood loss (3225.0mL v 1496.7mL); blood transfusions (8.1units v 2.8units); ICU admissions (79% v 52%) and longer ICU stays (7.7d v 4.6d). MCF patients had significantly (p<0.05): more complications (72% v 39%); complications per patient (2.07 v 1.48); and higher rates of wound complications: dehiscence (61% v 23%) and infections (50% v 25%).

MCF is important for closing large pelvic defects after exenteration surgery. In this series MCF patients had more complex and prolonged surgical procedures with significantly more post-operative complications.

Status: Manuscript in preparation