Perioperative chemotherapy with FOLFOX4 and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC Intergroup trial 40983): a randomised controlled trial

ObjectivesIncisional hernias are common complications of midline abdominal closure. The ‘Hughes Repair’ combines a standard mass closure with a series of horizontal and two vertical mattress sutures within a single suture. There is evidence to suggest this technique is as effective as mesh repair for the operative management of incisional hernias; however, no trials have compared Hughes repair with standard mass closure for the prevention of incisional hernia formation. This paper aims to test the feasibility of running a randomised controlled trial of a comparison of abdominal wall closure methods following midline incisional surgery for colorectal cancer, in preparation to a definitive randomised controlled trial.Design and settingA feasibility trial (with 1:1 randomisation) conducted perioperatively during colorectal cancer surgery.ParticipantsPatients undergoing midline incisional surgery for resection of colorectal cancer.InterventionsComparison of two suture techniques (Hughes repair or standard mass closure) for the closure of the midline abdominal wound following surgery for colorectal cancer.Primary and secondary outcomesA 30-patient feasibility trial assessed recruitment, randomisation, deliverability and early safety of the surgical techniques used.ResultsA total of 30 patients were randomised from 43 patients recruited and consented, over a 5-month period. 14 and 16 patients were randomised to arms A and B, respectively. There was one superficial surgical site infection (SSI) and two organ space SSIs reported in arm A, and two superficial SSIs and one complete wound dehiscence in arm B. There were no suspected unexpected serious adverse reactions reported in either arm. Independent data monitoring committee found no early safety concerns.ConclusionsThe feasibility trial found no early safety concerns and demonstrated that the trial was acceptable to patients. Progression to the pilot and main phases of the trial has now commenced following approval by the independent data monitoring committee.Trial registration numberISRCTN 25616490.

Download Full-text

Is referral of postsurgical colorectal cancer survivors to cardiac rehabilitation feasible and acceptable? A pragmatic pilot randomised controlled trial with embedded qualitative study

BMJ Open ◽

10.1136/bmjopen-2015-009284 ◽

2016 ◽

Vol 6 (1) ◽

pp. e009284 ◽

Cited By ~ 14

Author(s):

Gill Hubbard ◽

Richard Adams ◽

Anna Campbell ◽

Lisa Kidd ◽

Stephen J Leslie ◽

...

Keyword(s):

Colorectal Cancer ◽

Randomised Controlled Trial ◽

Qualitative Study ◽

Cardiac Rehabilitation ◽

Cancer Survivors ◽

Controlled Trial ◽

Pilot Randomised Controlled Trial ◽

Colorectal Cancer Survivors ◽

Randomised Controlled

Download Full-text

Study protocol for an open labelled randomised controlled trial of perioperative oral nutrition supplement in breast and colorectal cancer patients undergoing elective surgery

Trials ◽

10.1186/s13063-021-05716-5 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

T. X. Wong ◽

S. T. Chen ◽

S. H. Ong ◽

S. Shyam ◽

P. Kandasami ◽

...

Keyword(s):

Colorectal Cancer ◽

Randomised Controlled Trial ◽

Cancer Patients ◽

Elective Surgery ◽

Controlled Trial ◽

Normal Diet ◽

Oral Nutrition ◽

Nutrition Supplement ◽

Randomised Controlled ◽

Colorectal Cancer Patients

Abstract Background While it is well established that perioperative use of oral nutrition supplement (ONS) improves nutrition status among severely malnourished surgical cancer patients, the evidence requires further substantiation for non-severely malnourished patients with cancer. This protocol paper presents the rationale and design of a randomised controlled trial to evaluate the effectiveness of preoperative as well as an extended 90-day postoperative use of ONS on nutritional and clinical outcomes among patients undergoing elective surgery for breast and colorectal cancer. Methods Patients with primary breast and colorectal cancer undergoing elective surgery are recruited from two tertiary hospitals. Eligible patients are assigned into one of the three intervention arms: (i) Group SS will receive ONS in addition to their normal diet up to 14 days preoperatively and postoperatively up to discharge; (ii) Group SS-E will receive ONS in addition to their normal diet up to 14 days preoperatively, postoperatively up to discharge and for an extended 90 days after discharge; and (iii) Group DS will receive ONS in addition to their normal diet postoperatively up to discharge from the hospital. The ONS is a standard formula fortified with lactium to aid in sleep for recovery. The primary endpoints include changes in weight, body mass index (BMI), serum albumin and prealbumin levels, while secondary endpoints are body composition (muscle and fat mass), muscle strength (handgrip strength), energy and protein intake, sleep quality, haemoglobin, inflammatory markers (transferrin, high sensitivity C-reactive protein, interleukin-6), stress marker (saliva cortisol), length of hospital stay and postoperative complication rate. Discussion This trial is expected to provide evidence on whether perioperative supplementation in breast and colorectal cancer patients presenting with high BMI and not severely malnourished but undergoing the stress of surgery would be beneficial in terms of nutritional and clinical outcomes. Trial registration ClinicalTrial.gov NCT04400552. Registered on 22 May 2020, retrospectively registered

Download Full-text

Sequential versus combination chemotherapy with capecitabine, irinotecan, and oxaliplatin in advanced colorectal cancer (CAIRO): a phase III randomised controlled trial

The Lancet ◽

10.1016/s0140-6736(07)61086-1 ◽

2007 ◽

Vol 370 (9582) ◽

pp. 135-142 ◽

Cited By ~ 444

Author(s):

Miriam Koopman ◽

Ninja F Antonini ◽

Joep Douma ◽

Jaap Wals ◽

Aafke H Honkoop ◽

...

Keyword(s):

Colorectal Cancer ◽

Randomised Controlled Trial ◽

Combination Chemotherapy ◽

Advanced Colorectal Cancer ◽

Controlled Trial ◽

Phase Iii ◽

Randomised Controlled

Download Full-text

Healthy Eating and Active Lifestyle After Bowel Cancer (HEAL ABC): feasibility randomised controlled trial protocol

Pilot and Feasibility Studies ◽

10.1186/s40814-020-00721-y ◽

2020 ◽

Vol 6 (1) ◽

Author(s):

Jana Sremanakova ◽

Anne Marie Sowerbutts ◽

Chris Todd ◽

Richard Cooke ◽

Sorrel Burden

Keyword(s):

Physical Activity ◽

Colorectal Cancer ◽

Randomised Controlled Trial ◽

Behaviour Change ◽

Healthy Eating ◽

Controlled Trial ◽

Bowel Cancer ◽

Active Lifestyle ◽

Feasibility Randomised Controlled Trial ◽

Randomised Controlled

Abstract Background Targeting modifiable lifestyle factors including diet and physical activity represents a potentially cost-effective strategy that could support a growing population of colorectal cancer survivors and improve their health outcomes. Currently, effective, evidence-based interventions and resources helping people after bowel cancer to adopt new lifestyle habits are lacking. The aim of this trial is to test the Healthy Eating and Active Lifestyle After Bowel Cancer (HEAL-ABC) intervention to inform a future definitive randomised controlled trial. Methods/design This is a feasibility randomised controlled trial. A total of 72 survivors who have completed surgery and all anticancer treatments will be recruited. The intervention group will receive HEAL-ABC resources based on behaviour change theory combined with supportive telephone calls informed by motivational interviewing every 2 weeks during the 3-month intervention, and once a month for 6 months to follow-up. Participants in the control group will follow usual care and have access to resources available in the public domain. The study is testing feasibility of the intervention including adherence and ability to collect data on anthropometry, body composition, diet, physical activity, behaviour change, quality of life, blood markers, contact with healthcare services, morbidities and overall survival. Discussion The proposed study will add to the evidence base by addressing an area where there is a paucity of data. This study on lifestyle interventions for people after colorectal cancer follows the Medical Research Council guidance on evaluating complex interventions in clinical practice. It focuses on people living after treatment for colorectal cancer and targets an important research area identified by cancer survivors as a research priority reported by the National Cancer Institute and James Lind Alliance UK. Trial registration ClinicalTrials.gov NCT04227353 approved on the 13th of January 2020

Download Full-text