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

Patients Undergoing Surgery for Rectal Cancer

Prior to surgery, patients will be asked to complete baseline surveys. In addition, a random subsample of approximately 30 patients will be asked to participate in a short qualitative interview to explore expectations regarding bowel function and quality of life following surgery. Follow-up surveys will be completed at 6, 12 and 24 months after bowel continuity has been restored (defined by their last surgical procedure). Patients with a permanent stoma will receive the Stoma-specific QOL questions in place of the MSKCC Bowel Function Instrument at 6 and 12 months after initial surgery.

Questionaires

Julio Garcia-Aguilar, MD

The purpose of this study is to find out what happens to patients after they have surgery for rectal cancer. After being treated for rectal cancer, patients tell us that their bowel, bladder and sexual function have changed. We are trying to understand how these changes affect your quality of life. The research that we have now does not explain these changes or problems very well. The patients will be asked questions about bowel function, bladder function, sexual function, and quality of life so we can understand these changes better. This will help us take better care of our patients in the future, before and after their treatment for rectal cancer.

Rectal cancer is the second most common cancer in North America. Therapy has rapidly improved over the last 20 years, and the surgical technique of total mesorectal excision, as well as advances in radiation and chemotherapy, have resulted in improved survival and decreased local recurrence. As a result, survivorship issues become increasingly important for patients with rectal cancer.

Patients uniformly demonstrate a strong desire to avoid a permanent stoma and show strong preferences for sphincter preserving surgery (SPS). With the introduction of the circular stapler, SPS is technically possible in a higher proportion of patients. Additionally, even tumors at the anorectal ring are considered amenable to SPS in select patients with ultra-low rectal cancers.

At present, long-term outcomes after rectal cancer surgery are poorly understood. Bowel, bladder and sexual function appear to be negatively affected by multi-modality therapy. However, function has been poorly studied, and it is difficult to translate the data into clinically meaningful information for patients. Clinically, bowel, bladder and sexual dysfunction seem to affect quality of life (QOL), although this has never been well studied. It is important to quantify the extent of impairment so that it can be used to educate patients preoperatively. However, translating these data to clinicians and patients remains challenging, and efforts to convey the data in a meaningful manner preoperatively constitute an important element in managing patient expectations. By understanding patients' baseline needs, expectations and satisfaction at the time of the preoperative consent, we can begin to develop novel preoperative strategies for educating patients about postoperative function and quality of life in a meaningful manner, so that they may better adapt after surgery. We ultimately plan to use data from this study to develop and subsequently evaluate the role of an educational tool outlining functional outcomes after rectal cancer surgery.

Functional Outcomes and Quality of Life in Patients Undergoing Surgery for Rectal Cancer

Memorial Sloan Kettering Cancer Center

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

Herbal and Botanical

All Drugs and Chemicals

Cola

Patients receive conventional resection with standard proximal excision margin. The sigmoid colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed.

Patients receive proximally extended resection. The whole sigmoid colon and rectum proximal to the tumor is removed, and the descending colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed.

The conventional technique requests an excision of at least 10 cm of bowel proximal to the tumor, and the sigmoid colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed.

Conventional resection

The modified technique requests an excision of the whole sigmoid colon and rectum proximal to the tumor, and the descending colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed.

Proximally extended resection

Qiyuan Qin, M.D.

Lei Wang, MD, PhD

Hui Wang, M.D.

Neoadjuvant chemoradiotherapy has been recommended as the standard preoperative treatment for locally advanced rectal cancer. However, preoperative radiotherapy increases the risk of bowel dysfunction after sphincter-preserving surgery, for which patients suffer from incontinence, urgency, and unpredictability defecation problems. Furthermore, preoperative chemoradiotherapy is a potential risk factor of anastomotic leakage and stenosis after rectal cancer surgery.

Unhealthy anastomosis, with both ends of injured bowel segments after pelvic radiation, is a major concern. When conventional surgical procedures would retain part of sigmoid colon that has been included in the radiation target, sphincter-preserving surgery with proximally extended resection margin could provide an intact proximal colon limb for the anastomosis.

It is not known yet whether proximally extended resection improves postoperative bowel function or anastomotic integrity for patients with rectal cancer after neoadjuvant chemoradiotherapy. The proposed study will compare sphincter-preserving surgery with and without proximally extended resection margin, to observe the postoperative bowel function, as well as the incidence of anastomotic complication. This study will examine a new surgical strategy, which potentially benefits the patients undergoing neoadjuvant chemoradiotherapy.

Proximally Extended Resection for Rectal Cancer After Neoadjuvant Chemoradiotherapy

Randomized Trial of Sphincter-Preserving Surgery With Proximally Extended Resection Margin on Bowel Function and Anastomotic Complication for Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy

Low anterior resection syndrome score (LARS score) will be used to assess the bowel function. Number of participants with major LARS will be calculated for the incidence of major bowel dysfunction.

Low anterior resection syndrome score (LARS score) will be used to assess the bowel function.

Quality of life will be assessed by EORTC QLQ-C30 and EORTC QLQ-CR29.

Shanghai Changzheng Hospital

Peking Union Medical College Hospital

Sixth Affiliated Hospital, Sun Yat-sen University

Symptoms and General Pathology

Infections

Musculoskeletal Diseases

Diseases and Abnormalities at or Before Birth

Hypertrophy

Spondylitis

Constriction, Pathologic

Spondylarthritis

Intervertebral Disc Displacement

Intervertebral Disc Degeneration

Spinal Stenosis

Spondylosis

Spinal Curvatures

Spinal Neoplasms

Osteoarthropathy, Primary Hypertrophic

Communicable Diseases

Bone Diseases

Bone Diseases, Infectious

Spinal Diseases

Joint Diseases

Pathological Conditions, Anatomical

Hernia

Bone Neoplasms

Genetic Diseases, Inborn

During standard intraoperative neuromonitoring, additional smooth muscle free-running and stimulated EMG will be recorded from corporal tissues (corpus spongiosum) of male and female genitalia from all patients who consent to participate in the study. EMG data and additional demographics and clinical data (e.g. operative time, adverse events) will be collected for each patient.

Two intracorporal electrode needles will be inserted beneath the skin of the genitalia. After insertion, the electrodes will be secured and connected by leads to two standard neurophysiological devices for differential amplification, display, and storage. Smooth muscle free-running (continuous) and stimulated EMG will be recorded.

Autonomic nervous system monitoring

Anna Lintelmann, MPH

Amy Schrecengost, BS

Nilanjana Banerji, MS, PhD

Stanley Skinner, MD

A safety and feasibility study of free-run and stimulated corporal electromyography (EMG) to assess autonomic neural function during spinal and/or pelvic surgery in women and men.

This is a safety and efficacy trial to assess autonomic neural function monitoring during spinal and/or pelvic surgery.

During standard intraoperative neuromonitoring, additional smooth muscle free-running and stimulated EMG will be recorded from corporal tissues (corpus spongiosum) of male and female genitalia from individual patients. Throughout the duration of the spinal surgery, the neurophysiologist will continuously monitor autonomic function. Smooth muscle free-running (continuous) and stimulated EMG will be recorded.

EMG data and additional demographics and clinical data (e.g. operative time, adverse events) will be collected for each patient. The success rates of 1) credible and safe EMG recording and 2) positive EMG responses to each stimulation method will be calculated.

Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study

Free-run smooth muscle EMG will be monitored continuously throughout the duration of surgery. Any changes in the EMG, as indicated by fluctuations in amplitude and/or frequency, will be recorded.

Smooth muscle EMG in response to stimulations and recordings will be monitored. Any changes in the EMG, as indicated by fluctuations in amplitude and/or frequency in response to IOMN (intraoperative neuromonitoring) stimulations and recordings, will be recorded.

Stanley Skinner

Neurophysiologist

Syndrome

Irritable Bowel Syndrome

Colonic Diseases

Colonic Diseases, Functional

All surgeries during the study were performed by the same experienced surgical team and were performed following TME principles. End-to-side anastomosis was used to perform colorectal anastomosis after primary tumor resection.

All surgeries during the study were performed by the same experienced surgical team and were performed following TME principles. After resection of the primary tumor, end-to-end anastomosis was used for colorectal anastomosis.

Different reconstruction methods should be performed after sphincter preservation surgery in two groups.The methods include end-to-end anastomosis or end-to-side anastomosis

different reconstruction methods

Yingjiang Ye, M.D. ＆ PhD.

Colorectal cancer is one of the most common malignant tumors in the world. Surgery is still the main treatment for rectal cancer. With the popularization of stapler technology and the application of preoperative neoadjuvant therapy, more and more patients with rectal cancer have treated sphincter preservation surgery for rectal cancer. postoperative observation found that some patients with rectal cancer anus-preserving surgery had different degrees of defecation dysfunction after surgery, such as incontinence, tightness, increased frequency of bowel movements, and constipation. These clinical symptoms have been classified as "Low anterior resection syndrome (LARS)" in recent years.Now there is no treatment for LARS.Meanwhile,J-pouch and side-to-end anastomosis can help the patients,but there is few trials can prove this.This trial means to prove weather side-to-end anastomosis can improve bowel of rectal patients afer surgery.

Colorectal cancer is one of the most common malignant tumors in the world. There are more than 1.7 million new cases worldwide each year, accounting for 9.7% of all cancers. Among them, 840,000 deaths, accounting for 8.5% of all cancer deaths, mortality Second only to lung cancer, liver cancer and gastric cancer. China is a country with high incidence of colorectal cancer, and its morbidity and mortality are the fifth highest in malignant tumors. Rectal cancer is the most common type of colorectal cancer. The incidence of rectal cancer in China is 14.0/100,000, which is the 7th cancer incidence rate in China.

Surgery is still the main treatment for rectal cancer. With the popularization of stapler technology and the application of preoperative neoadjuvant therapy, more and more patients with rectal cancer have treated sphincter preservation surgery for rectal cancer. The proportion of permanent ostomy has dropped to 16.9% to 29% . With the popularity of TME principles worldwide, the standardized treatment of rectal cancer is becoming more and more stable, and the postoperative survival rate of patients is steadily increasing. However, postoperative observation found that some patients with rectal cancer anus-preserving surgery had different degrees of defecation dysfunction after surgery, such as incontinence, tightness, increased frequency of bowel movements, and constipation. These clinical symptoms have been classified as "Low anterior resection syndrome (LARS)" in recent years. The research on LARS is still in its infancy, and its pathogenesis, influencing factors, pathophysiology and other explorations are not deep enough. Behind the various symptoms of low anterior resection syndrome is a complex pathophysiological basis. The symptoms and severity are affected by many changes in intestinal anatomy, nerve injury, postoperative healing process, diet structure and psychological status. The risk factors associated with the onset of defecation dysfunction after rectal cancer anal sphincter preservation include radiotherapy, total mesorectal excision, and tumor location. The role of various risk factors in the pathogenesis of defecation dysfunction after rectal cancer anal sphincter preservation is still controversial. At present, the diagnosis, grading and treatment of LARS are still in the exploration stage, and there is still no effective treatment.

Since the 1980s, a variety of colon-rectal anastomosis methods have been used in clinical practice to improve the dysfunction of rectal cancer after anal sphincter preservation, including J-pouch anastomosis, Colon transverse anastomosis, and end-to-side anastomosis. Each of the above three methods has its advantages and disadvantages: J-type storage bag improves the postoperative bowel movement anastomosis effect, but the technique is complicated and has more anastomotic symptoms; the colon transverse of the colon has a wide application range but the effect of improving the defecation function is poor; It has the longest history, but the time to apply to functional protection is the shortest, and there are few studies. Huttner et al published a meta-analysis published in 2015 (including 1636 cases from 21 clinical trials reports. Compared with end-to-end anastomosis, J-pouch can reduce the frequency of defecation and antidiarrheal drugs after 1 year after surgery. Similar results have been achieved with end-to-side anastomosis and colonic angioplasty; a review published by Brown et al also suggests that J-pouch can reduce the frequency of defecation and urgency of bowel movements during early (0-8 months) and mid-term (8-18 Months) .The end-to-side anastomosis achieved similar effects in each stage of the J-pouch, so it can be inferred that the end-to-side anastomosis (relative to end-to-end anastomosis) can improve postoperative defecation function. A retrospective study of end-to-end anastomosis and end-to-end anastomosis published in China also found that end-to-side anastomosis can reduce bowel movements and improve postoperative defecation function at 6 months after surgery. However, there is still no prospective clinical trial comparing the end-to-side anastomosis and end-to-end anastomosis for postoperative intestinal function. The ideal anastomosis should meet the characteristics of exact effect, simple operation and low complications. The end-to-side anastomosis is one of the potential choices, but its validity and safety lack relevant research evidence and need further study.

Postoperative Bowel Function After SPS by Different Reconstruction Methods

A Randomized Study From Single Institutions on Postoperative Bowel Function Following Sphincter Preservation Surgery in Patients With Rectal Cancer by Different Reconstruction Methods

Each patients will be interviewed by telephone and asked to answer a copy of LARS score questionnaire.

Designed for LARS patients only, the LARS score is a total score questionnaire containing five single choice questions with a corresponding score for each option. Each of the five questions tested a single symptom of the bowel function, including incontinence for flatus(score value from 0 to 7), incontinence for liquid stool (score value from 0 to 3), frequency of bowel movement (score value from 0 to 5), clustering of stools (score value from 0 to 11) and urgency (score value from 0 to 16). According to the total score of each patient, the questionnaire can evaluate the defecation function of the subject, which is divided into three categories from best to worst: no LARS (0 to 20), miner LARS (21 to 29) and major LARS (30 to 42).

surgery time, blood loss, quality of surgical specimen, etc. will be record to assess safety of each reconstruction method.

The incidence of key post-operative complication like anastomosis leakage, post-operative bleeding, server bowel obstruction, intra-abdominal abscess and surgical site infection, etc. will be record.

Each patients will be interviewed by telephone and asked to answer a copy of LARS score questionnaire after one year of operation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Functional Outcomes and Quality of Life in Patients Undergoing Surgery for Rectal Cancer	NCT00579579	Rectal Cancer	Questionaires	18 Years -	Memorial Sloan Kettering Cancer Center
Early Ileostomy Closure for Rectal Cancer Patients in North America	NCT05027737	Ileostomy - Sto... Rectal Cancer	Early Ileostomy...	18 Years - 90 Years	Jewish General Hospital
Proximally Extended Resection for Rectal Cancer After Neoadjuvant Chemoradiotherapy	NCT02649647	Rectal Cancer	Conventional re... Proximally exte...	18 Years - 75 Years	Sixth Affiliated Hospital, Sun Yat-sen University
Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study	NCT02873182	Intervertebral ... Intervertebral ... Spinal Curvatur... Spinal Stenosis Spondylitis Spondylosis Osteoarthropath... Spinal Neoplasm...	Autonomic nervo...	18 Years - 70 Years	Allina Health System
Postoperative Bowel Function After SPS by Different Reconstruction Methods	NCT03669237	Bowel; Function...	different recon...	18 Years - 100 Years	Peking University People's Hospital
Proximally Extended Resection for Rectal Cancer After Neoadjuvant Chemoradiotherapy	NCT02649647	Rectal Cancer	Conventional re... Proximally exte...	18 Years - 75 Years	Sixth Affiliated Hospital, Sun Yat-sen University
Postoperative Bowel Function After SPS by Different Reconstruction Methods	NCT03669237	Bowel; Function...	different recon...	18 Years - 100 Years	Peking University People's Hospital
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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