Neoplasms

Digestive System Diseases

All Conditions

Behaviors and Mental Disorders

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

Following a negative leak test (CT scan with rectally-administered water-soluble contrast on post-operative day 7, 8 or 9), patients will undergo standardized reversal of their diverting loop ileostomy (stapled side-side functional end-to end anastomosis, purse-string closure of the ileostomy wound, and no use of epidural analgesia) between post-operative days 10-14.

Following a negative leak test (CT scan with rectally-administered water-soluble contrast on post-operative day 7, 8 or 9), patients will undergo a standardized reversal of their diverting loop ileostomy. The latter will be performed with a stapled side-side functional end-to end anastomosis, purse-string closure of the ileostomy wound, and no use of epidural analgesia and will be performed no earlier than 12 weeks following their index surgery.

Early Ileostomy Closure

Natasha Caminsky, MD

Sarah Sabboobeh, MSc

Amandeep Ghuman, MD, MPH, FRCSC

Nawar AlKhamesi, MD

Marylise Boutros, MD

Marie Demian, MSc

Sender Liberman, MD

Our preliminary work demonstrates that there is buy-in from both patients and surgeons with regards to early ileostomy closure (EIC) for select rectal cancer patients undergoing restorative proctectomy (RP) and diverting loop ileostomy (DLI). The feedback from leaders in Europe further supports the need for a large scale randomized-controlled trial (RCT) on this subject in North America. Should the results of such a study be favourable, we believe it could support a change in practice that would be beneficial to patients and the health care system alike. Furthermore, our work will help identify which patients and practices are suitable for EIC.

The goal of our project is to determine whether EIC in rectal cancer patients undergoing RP with a DLI is safe, feasible and beneficial in a North American population. Specifically, our primary objective is to compare the severity of complications between patients undergoing EIC versus traditional (late) closure. Our secondary objectives include assessing the difference in quality of life (QoL), early and late bowel function, and cost of care between these two groups.

Eligible adults (≥18 years-old) from one a large colorectal surgery practice in Canada who (1) underwent RP with creation of a DLI for the treatment of rectal cancer and (2) have a negative anastomotic leak test on post-operative day 7-9 which will consist of a flexible sigmoidoscopy and CT scan with rectally-administered water soluble contrast. Patients will be excluded if there is (1) peri-operative immunosuppression, (2) age-adjusted Charlson Comorbidity Index \>6, (3) other major surgery during the index operation, and (4) any major complications (Clavien Dindo Grade III-V) following RP. Eligible participants will be randomized (1:1): Intervention group (EIC): Following a negative leak test, patients will undergo standardized reversal of their DLI (stapled side-side functional end-to end anastomosis, purse-string closure of the ileostomy wound and no use of epidural analgesia) between post-operative days 10-14. Control group (standard practice): Following a negative leak test, patients will undergo a standardized reversal of their DLI no earlier than 12 weeks following their index surgery.

The primary outcome will be comprehensive complication index (CCI) at 12 months following RP. Secondary outcomes will include: CCI at 2-, 6-, and 9-months following RP; recovery from surgery using the PROMIS 29 profile at 7- and 14-days post RP; bowel function, as measured using the Low Anterior Resection Syndrome (LARS) Score at 2-, 6-, 9-, and 12-months post-DLI closure; post-operative ileus, as defined by intolerance to oral intake in the absence of clinical or radiological signs of obstruction, will be measured prospectively after DLI closure; overall QoL, as measured by the EORTC CR30 and QLQ-CR38 at 0-, 2-, 6-, 9-, and 12-months post-RP; cost, as measured from the perspective of the healthcare system \[length of hospital stay (RP, ileostomy closure, and any readmissions), interventions in any setting following RP, and appliance-related costs\] will be assessed at 6- and 12-months post-index surgery. Treatment effect on the primary outcome (CCI at 12 months) will be modeled using linear regression.

Multi-centre, assessor-blind, parallel-groups (1:1), pragmatic, randomized controlled trial

Early Ileostomy Closure for Rectal Cancer Patients in North America

Early Ileostomy Closure Following Restorative Proctectomy for Rectal Cancer Patients: A North American Multicenter Randomized-Controlled Trial (RCT)

Intolerance to oral intake in the absence of clinical or radiological signs of obstruction, measured prospectively after diverting loop ileostomy closure

Measured from the perspective of the healthcare system, by combining cost of each hospital admission (restorative proctectomy, diverting loop ileostomy closure, and any readmissions), interventions in any setting following restorative proctectomy, and stoma appliance-related costs (measured based on the average number of bags and stoma appliances used per week by each patient).

Number of weeks elapsed from date of restorative proctectomy to date of initiation of adjuvant chemotherapy

PROMIS-29 profile v2.0. PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation of that population. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.

Low Anterior Resection Syndrome (LARS) Score. The score ranges from 0-42 with a score of 0-20 representing "No LARS", a score of 21-29 representing "Minor LARS" and a score of 30-42 representing "Major LARS".

Health-related quality of life of cancer patients. All of the scale ranges in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).

Health-related quality of life of colorectal cancer patients. All of the scale ranges in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).

McGill University Health Centre/Research Institute of the McGill University Health Centre

Jewish General Hospital

Associate Professor

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Postoperative Complications

Head and Neck Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Urologic Diseases

All Drugs and Chemicals

Psychotropic Drugs

Imidacloprid

Bupropion

Nicotine

Varenicline

The study intervention consists of a smoking cessation counselling meeting by a Tabacco Treatment Specialist (TSS) 4 weeks before surgery. The goal of this first intervention meeting is to implement an individual treatment plan for preoperative smoking cessation.

Patients randomised to the control arm will get advice only. Their preoperative course will be as if they were not participating in this study, meaning they will receive inconsistent perioperative smoking cessation advice from nurses, surgeons, or anaesthesiologists but no further study-specific smoking cessation intervention. Importantly, participants in the control group will not be discouraged from using perioperative smoking cessation aids and can still obtain help on one's own initiative.

The study intervention consists of an interview by a Tabacco Treatment Specialist (TSS) 4 weeks before surgery with individual counselling and offered nicotine substitution. The intervention meeting is based on the Chronic Care Model (CCM) to improve quality of ambulatory care.

In brief, the intervention includes:

* Informative content about advantages of smoking cessation
* Scheduling service for a motivational interview by a TSS in office to implement a treatment plan
* For participants willing to quit smoking a preoperative quit day will be scheduled after the first intervention meeting 2-3 weeks before surgery
* Patients will be encouraged by a TSS to use nicotine replacement. Bupropion or Vareniclin will be provided on an individual basis
* TSS will schedule repeated follow-up meetings to support smoking abstinence or nicotine reduction before and after surgery for all patients

Intensive preoperative smoking cessation counselling

Studienkoordination Tumorzentrum

Christian Fankhauser, PD Dr. med.

Background: At present, effectively implementing smoking cessation programs in the health care system constitutes a major challenge. A unique opportunity to initiate smoking cessation focuses on smokers scheduled for surgery. These patients are not only highly motivated to quit smoking but also likely to benefit from a reduction in postoperative complications which may translate into a decrease of costs. Nevertheless, surgical patients are not routinely informed about the benefits of preoperative smoking cessation. Potential reasons for this missed opportunity may be lack of time and training of surgeons and anesthesiologists. The investigators therefore aim to analyse the impact of a preoperative high-intensity smoking cessation intervention on surgical complications up to a 90-day postoperative period in patients of various surgical disciplines. The hypothesis is that preoperative smoking cessation program improves outcomes in smokers undergoing intermediate to high-risk surgery. The primary objective is to compare complications between patients with an institutional multifaceted smoking cessation intervention starting four weeks before surgery compared to patients in the advice only group (control group) within a 90-day postoperative period. The primary endpoint is the Comprehensive Complication Index (CCI®) within 90 days of surgery. Secondary outcomes include length of hospital stay, cost of hospital stay, smoking abstinence, reduction in nicotine consumption.

Methods: The present study is a single center, randomized trial with two parallel groups of smokers scheduled for surgery comparing surgery alone and surgery with preoperative smoking cessation. The investigators plan to randomize 251 patients. The primary endpoint is the Comprehensive Complication Index up to a 90-day postoperative period. The secondary endpoints include comparison of smoking abstinence, quality of life, mental health, length of stay, costs of care and difference in hospital reimbursement between the two groups.

Discussion: The hypothesis is that preoperative smoking cessation program improves outcomes in smokers undergoing surgery.

Patients will be randomised in a 1:1 ratio to either the intervention or control group using service of the University of Graz (www.randomizer.at). Before randomisation patients will be pre-stratified for age (≤60, \>60 years) and procedure (intermediate versus high-risk procedures). Both factors have been identified in a previous retrospective cohort study at our institution as risk factors for complications. For that reason, minimization, as an efficient way to control for confounding in small to moderately sized trials, will be used. Also, minimization automatically ensures concealment of random allocation since there is no pre-existing randomization list.

Throughout the study patient data is collected in the electronic health record (LUKiS) in an uncoded manner. Allocation will be blinded. At the end of the study the LUKiS reporting team will generate a report, which will include all study data in a de-identified form. The analysis of the report with the pseudonymized data will be performed by the project statistician.

Preoperative Smoking Cessation in Patients Undergoing Surgery

Preoperative Smoking Cessation Program in Patients Undergoing Intermediate to High-risk Surgery: a Randomized, Single-blinded, Controlled Trial

The primary endpoint is the Comprehensive Complication Index (CCI) within 90 days of surgery. The CCI is calculated as the sum of all Clavien-Dindo complications that are weighted for their severity (multiplication of the median preference values from patients and physicians). The final formula yields a continuous scale that ranks the cumulative burden from any combination of complications from 0 to 100 with higher values indicating a higher cumulative burden in a single patient. As a composite complication score, the CCI has the advantage of reflecting the overall burden of the postoperative course that affects the health of patients and their quality of life. In addition, the CCI is a powerful endpoint in trials, as it allows sample size up to nine times lower compared with traditional morbidity endpoints.

Days of hospital stay for planned surgery

Costs of hospital stay for planned surgery

Readmission rates for in-patient hospital stay after surgery

Number of patients who successfully quit smoking

Decrease or increase of daily nicotine consumption

The outcome is measured using the Hospital anxiety and depression scale (HADS) before surgery. The score ranges from 0 to 42 with higher values indicating a higher probability of a mood disorder.

unplanned postoperative intermediate care or intensive care unit admission

Stage of the Transtheoretical Model of behaviour change

The outcome is measured using the 36-Item Short Form Survey (SF-36). The score ranges from 0 to 100 with higher values indicating a more favorable health state.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Early Ileostomy Closure for Rectal Cancer Patients in North America	NCT05027737	Ileostomy - Sto... Rectal Cancer	Early Ileostomy...	18 Years - 90 Years	Jewish General Hospital
Preoperative Smoking Cessation in Patients Undergoing Surgery	NCT05192837	Smoking Cessati... Smoking Reducti... Surgery--Compli... Surgery Cancer Postoperative C... Perioperative C... Smoking Abdominal Cance... Thoracic Cancer Urologic Cancer Gynecologic Can... Head and Neck C...	Intensive preop...	18 Years -	Luzerner Kantonsspital
Early Ileostomy Closure for Rectal Cancer Patients in North America	NCT05027737	Ileostomy - Sto... Rectal Cancer	Early Ileostomy...	18 Years - 90 Years	Jewish General Hospital

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