Comparative Study of Laparoscopic Versus Open Operations for Colon Cancer
Comparative Study of Laparoscopic Versus Open Operations for Colon Cancer
The purpose of this study is to compare the short and long term outcomes of people who have
 colon cancers removed either by laparotomy (a large cut in the abdominal wall) or by a
 laparoscopic assisted approach (keyhole surgery). This study involves 37 credentialled
 surgeons in 20 approved hospitals across Australasia and during the recruitment period (Jan
 1998 to March 2005) 601 patients were recruited into the ALCCaS Trial.
AIMS

 The primary aim of the study is to test the hypothesis that tumour related disease free
 interval and overall survival are equivalent regardless whether patients receive laparoscopic
 colon resection (LCR) or open colon resection (OCR) at three and five years post operatively.
 The secondary aims of the study are to determine the safety of LCR compared to OCR and 30 day
 mortality and compare post operative pain, paralytic ileus, early and late morbidities
 (including wound site recurrence), recovery, transfusion requirements, cost and quality of
 life scores.

 BACKGROUND

 The ALCCaS Trial is an Australasian, multicentred, prospective, randomised clinical study
 comparing laparoscopic and conventional open surgical treatments of colon cancer in adults.
 This trial has been recruiting patients since 1998.

 Patients are randomised to receive either laparoscopic or conventional open resection for
 colon cancer. A Randomisation Centre was established to provide a 24-hour randomisation
 service and this centre is situated in Christchurch, New Zealand. The Health Research Council
 of New Zealand Data Safety Committee, chaired by Professor Tom Fleming, access the ALCCaS
 Trial annually to ensure that it meets strict ethical and research related criteria.

 During the recruitment period (Jan 1998 to March 2005) 601 patients were recruited into the
 ALCCaS Trial. There have been 37 surgeons involved in recruiting patients at 20 hospitals
 within Australia and New Zealand. All surgeons participating in the ALCCaS trial are
 accredited in laparoscopic surgical techniques. To gain accreditation, a surgeon must have
 carried out no less than 20 supervised colon resections and must provide video evidence of
 two laparoscopic colonic resections for review. Surgeons from throughout Australia and New
 Zealand are participating in this study. The Research Ethics Committees at a variety of
 hospitals throughout New South Wales, Queensland, South Australia, Victoria, Western
 Australia and New Zealand have approved the study.

 DATA COLLECTION

 The type of colon resection performed by the individual surgeon will follow standard
 oncologically safe principles. The following intra-operative details will be collected, the
 patient epidemiology, ASA status, previous abdominal surgery, incision type, site of
 carcinoma, modality of diagnosis, pre operative haemoglobin and lung function tests, pre
 operative blood transfusion, planned operation, planned incision. Intra operatively the date
 of the operation, whether DVT prophylaxis has been used, the type of bowel preparation, the
 type of operation performed, if the laparoscopic procedure is performed whether it included
 mobilisation of the bowel, ligation of main artery and vein, transection of the bowel,
 resection of the bowel and anastomosis done as an intraperitoneal procedure are recorded.

 The use of cytotoxic irrigation of the peritoneum, wound and colonic lumen is noted.
 Estimated surgical blood loss and intra operative blood transfusion is recorded. The post
 operative position of the tumour is noted. The type of incision and size of incision is
 recorded. Any reason for change in planned incision is recorded and the theatre utilisation,
 and total anaesthetic time and duration of the operative procedure are recorded. Intra
 operative temperature record is kept. Reason for stoma formation, if applicable, is recorded.
 The intra operative costs and disposable items are identified. Intra operative complications
 are identified as well as adverse events involving surgical equipment.

 In the post operative phase the total intravenous fluid requirement, blood transfusion, pain
 scores, amount of Morphine used, whether the patient vomited and whether nasogastric tube is
 required as well as lung function tests and any adverse events are noted at 30 minutes
 following the procedure, 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144
 hours, 168 hours and continued daily until the patient is discharged if not already
 discharged at that time. At discharge from hospital, total hospital days are identified as
 well as time in high dependency unit or intensive care unit, reason for delay in discharge is
 noted, post operative events including cardiac, respiratory, renal, ileus, wound infection,
 anastomotic leakage and other events are identified.

 Pathology includes the site of tumour, TNM staging, ACPS staging, length of resected colon,
 proximal clearance, distal clearance, number of nodes obtained, tumour differentiation,
 venous invasion, perineal invasion and histological type. Adjuvant chemotherapy if planned is
 noted. Patients in the study may be entered into an adjuvant chemotherapy trial following
 surgery provided the subsequent trial does not have radiation as a component of therapy and
 that the chemotherapy trial allows entering of patients from both surgical arms of the study.
 Follow up is quarterly for the first year, 6 monthly for year two and three and then annually
 until year five. At follow up wounds are check for any evidence of recurrence. A colonoscopy
 is performed 12 months following resection and then every three years following that if
 negative. Chest xray, abdominal CT or liver ultrasound, a complete blood picture are
 performed if clinically indicated, CEA's performed six monthly.

 FOLLOW-UP SCHEDULE

 Patients are followed for tumour recurrence and survival. Patients are advised on, and
 offered standard treatment with, adjuvant therapy. Follow-up is standardised to provide
 accurate data on recurrence and survival and more frequent examinations and investigations
 are performed if clinically indicated.

 Frequency of Follow-up:

 The minimum number of follow-up evaluations is as follows:

 -  every 3 months for the lst year.

 -  every 6 months for the 2nd and 3rd years.

 -  annually for the 4th and 5th years.

 Test Schedule:

 The minimal requirements for follow-up investigations are as follows:

 -  History and examination with a specific check for tumour wound recurrence.

 -  Colon evaluation including colonoscopy or sigmoidoscopy plus barium enema.

 -  Annual examination if positive for neoplasia (earlier if preoperative proximal
 examination is incomplete for technical reasons); examination every 3 years if negative.

 -  haemoglobin and white cell count

 -  creatinine, SGOT, alkaline phosphatase, total bilirubin, CEA

 -  Chest X-ray

 -  Abdominal CT scan or liver ultrasound annually for 5 years.

 -  Quality of Life and Complications documentation postoperatively at 2 days, 2 weeks, 2
 months and 18 months.

 SIGNIFICANCE AND OUTCOMES

 The study will determine the efficacy and safety of laparoscopic assisted resection of
 colonic adenocarcinoma. It will also answer questions of cost effectiveness and quality of
 life improvement. It will determine if port site recurrence is a real issue in this type of
 surgery.

 The study will also give valuable data about the outcomes of patients undergoing laparotomy
 in regard to current length of hospital stay, effectiveness of post-operative analgesia, in
 hospital complications and transfusion requirements.
Inclusion Criteria:

 -  Clinical diagnosis of a single adenocarcinoma of the ascending, descending, or sigmoid
 colon

 -  18 years of age or older

 -  Able to give informed consent

 -  Must be able to participate in follow-up examinations

 -  Must not have prohibitive scars or adhesions from previous abdominal surgery

 Exclusion Criteria:

 -  Advanced local disease, defined as >8cm in diameter or extensive infiltration

 -  Any previous or current malignant tumour with the previous 5 years (except superficial
 squamous or basal cell skin carcinoma or in situ cervical cancer)

 -  ASA 4

 -  ASA 5

 -  Associated gastrointestinal disease

 -  Dukes D disease

 -  Emergency presentation

 -  Massive bleeding

 -  Morbid obesity

 -  Pregnancy

 -  Rectal cancer

 -  Transverse colon cancer