Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Patients with colorectal cancer who had a radical resection surgery.

The contents of the questionnaire included gender, age, BMI, previous operation history, previous medication history, smoking history,patient mobility in the hospital, etc.Questionnaire was completed on the first postoperative day.From the third day to the end of the seventh day, patients were evaluated daily for gastrointestinal dysfunction.Postoperative mobility was assessed daily.

Questionnaires set

Wei Xia, Phd

Wending Cao, Master

Wei Xia, PhD

To understand the current situation of the postoperative gastrointestinal dysfunction in patients with colorectal cancer effect a radical cure, and analyze the risk factors, and build the colorectal cancer radical surgery in patients with gastrointestinal dysfunction risk prediction nomogram model decision tree classification and regression tree model, through internal validation evaluation the performance of the two models in the modeling data set and dividing the postoperative gastrointestinal dysfunction risk level.Two risk prediction models were used to carry out external verification, evaluate the clinical practicability and effectiveness of the model, and provide reference for further promotion of the model.

Colorectal cancer is characterized by high morbidity and mortality. Surgical treatment is the main treatment for colorectal cancer. Surgery is the best treatment for long-term survival.

Surgery is a destructive operation, can lead to local tissue injury, physical barrier damage, causes the patient's body, and a series of metabolism, neuroendocrine and immune response, all of which can cause local inflammation or systemic inflammatory response, also leads to occurrence of related complications, such as abdominal and pelvic infection, fever, anastomotic infection and fistula, intestinal obstruction, etc., Thus increasing the risk of postoperative complications. The trauma and irritation of gastrointestinal tract caused postoperative gastrointestinal dysfunction.

The procedure of surgery is accompanied by anesthesia, and the anesthesia mode of gastrointestinal surgery is mainly general anesthesia. Opioid analgesics are one of the most important components of general anesthesia. The most common side effects of opioid analgesics include postoperative intestinal obstruction, nausea and vomiting, chills and urinary retention. The use of anesthetic drugs further aggravated the postoperative gastrointestinal dysfunction.

At the same time, laparoscopic surgery must establish pneumoperitoneum pressure. In recent years, studies have suggested that pneumoperitoneum pressure can lead to changes in the body's internal environment, resulting in a series of pathophysiological changes such as tissue ischemia, intestinal edema, and release of inflammatory factors in the gastrointestinal tract, resulting in dysfunction of gastrointestinal function.

All the above reasons lead to gastrointestinal dysfunction as the highest complication after radical resection of colorectal cancer.A review of previous literature shows that there is no predictive assessment tool for gastrointestinal dysfunction in patients after radical resection of colorectal cancer.Therefore, it is necessary to construct a risk prediction model for patients after radical resection of colorectal cancer, and to verify the clinical practicability of the model through external verification.

Construction and Validation of Risk Prediction Model for Gastrointestinal Dysfunction of Patient With Colorectal Cancer

Construction and Validation of Risk Prediction Model for Gastrointestinal Dysfunction of Patient With Colorectal Cancer After Surgery

The gastrointestinal dysfunction will be assessed by 《Intake, Feeling nauseated, Emesis, Exam, and Duration of symptoms scoring system(I-FEED)》.The questionnaire consisted of 5 items.The scale contains five items, with the highest score of 3 and the lowest score of 0 for each item. Items include: tolerance to eating, presence of nausea, presence of vomiting, presence of bloating, duration of symptoms.A score of 6 or greater is a diagnosis of gastrointestinal dysfunction.

Smoking history will be assessed by 《Patient General Data Collection Form》,described by "yes" or "not".If patient has smoking history, the form will record how many cigarettes are smoked per day.

It will be assessed by《European Nutritional Risk Screening 2002(NRS 2002)》.If the score ≥3, it indicates high nutritional risk.The scale contains three items, namely, disease severity, nutritional status, and age. Among them, the highest score of disease severity and nutritional status was 3 and the lowest score was 0. Age ≥70 years is one point.

Medications history will be assessed by 《Patient General Data Collection Form》,described by "History of use of chemotherapeutics" 、"History of use of opiates"、"History of use of antithrombotic drugs" or "not".

Previous operation history will be assessed by 《Patient General Data Collection Form》,described by "History of non-abdominal surgery" 、"History of colectomy surgery"、"History of rectotomy surgery"、"History of other abdominal surgery" or "none".

It will be assessed by 《Bristol stool form scale》.Divided into 7 types, type 1 stool is granular, difficult to discharge. Type 2 is salami, which is hard. Type 3 is a strip with a cracked surface. Type 4 is strip, smooth surface, soft texture, easy to discharge. Type 5 stools are clumpy and soft in texture. Type 6 is a mushy loose stool. Type 7 is watery stool.

Patient Mobility l will be assessed by 《Inter-rater reliability of the Johns Hopkins Highest Level of Mobility Scale (JH-HLM)》.The maximum score of the scale is 8 points, 1 to 3 points means that only bed activities can be carried out, 4-5 points means that bedside activities can be carried out, and 6-8 points means that under-bed activities can be carried out. The higher the score, the higher the level of activity.

Sun Yat-sen University

Associate Professor

Nervous System Diseases

Heart and Blood Diseases

Stroke

A 250 ml feeding pouch containing 400 kcal.

Following the 7-day baseline period, all patients will enter the 28-day intervention period, where they will receive the intervention feed daily. The feed prescription will be determined on an individual basis by the Dietitian responsible for the patient's nutritional management

Bolus Pouch Feed

Rebecca Stratton, PhD

The primary aim of this study is to evaluate the impact of introducing a new enteral tube feed on health and feeding related quality of life. Secondary aims are to assess ease of use, liking, compliance, gastrointestinal tolerance, nutrient intake, anthropometric changes and safety.

Bolus enteral tube feeding (termed 'bolus feeding') is an increasingly common method of providing nutritional support to home enterally tube fed (HETF) patients, particularly those who are more active and/or require greater flexibility in their feeding regimen. However, current methods of bolus feeding are complex to administer, messy, may be unhygienic, and require and lead to a significant amount of plastic waste. Therefore, there is a clear need for a simpler and optimised way to provide bolus feeds. The aim of this study is to evaluate the impact of introducing a new enteral tube feed on health and feeding related quality of life, ease of use, liking, compliance, gastrointestinal tolerance, nutritional intake, anthropometry and safety. This is a prospective, longitudinal, 28-day intervention study with a 7-day baseline period.

This is a prospective, longitudinal, 28-day intervention study with a 7-day baseline period.

Bolus Pouch Feed Study

A Study Evaluating a Newly Designed Nutritional Tube Feeding Pouch for Bolus Feeding in Adults

At baseline, and at the mid-point and end of the intervention period, health and feeding related quality of life will be assessed by the FACT-EQ questionnaire.

At baseline, and at the mid-point and end of the intervention period, patients and dietitians will be asked to rate the ease of administering the enteral tube feed via a Likert-style questionnaire. Patients will also count the amount of feeding equipment required to administer the enteral feed at baseline, and at the midpoint and end of the intervention period.

At baseline, and at the mid-point and end of the intervention period, patients will be asked to rate their liking of their usual feeding method or of the intervention feed, respectively via a 7-point Likert scale questionnaire.

A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity (none, mild, moderate or severe) of common gastrointestinal symptoms (diarrhoea, constipation, bloating, abdominal discomfort, vomiting and nausea) will be recorded at the end of each week. Information about bowel movements will also be collected using the Bristol Stool Chart©.

Compliance with feed prescription will be assessed daily throughout the study by recording how much feed was received, to be recorded by the patient.

At baseline, and at the mid-point and end of the intervention period, the dietitian will conduct a 24-h dietary recall with the patient to record all food, drink and nutritional feeds provided in the 24 h prior. Trained research staff will subsequently analyse all records utilising a nutritional software package (Nutritics Professional v3.09, Nutritics, Ireland) for macro- and micro-nutrient intakes.

At baseline and at the end of the intervention period, body weight (kg) will be measured using standard methods to the nearest 0.1 kg using a weighing scale without heavy clothing.

All adverse events will be recorded throughout the study.

Nutricia UK Ltd

Coagulants

All Drugs and Chemicals

Hemostatics

The acupuncture will be performed within 6 hours after surgery Acupoint: bilateral Hegu (LI4), Zhigou (SJ6), Zusanli (ST36), Shangjuxu (ST37), All acupoints will be taken by tonifying method after obtaining qi, and unilaterally connected to an electroacupuncture instrument for electrical stimulation with a continuous wave frequency of 5 Hz and a stimulation intensity as tolerated by the patient for 30 min each time. Acupuncture stimulation was given every 12 h. The duration of treatment was from postoperative to the fourth postoperative day (d0-d4) or until the patient's first postoperative anal discharge or until the fourth day.

In order to achieve maximum patient blindness, both groups will use adhesive pads, and the sham acupuncture needle will have the same appearance as the traditional needle, with a blunt tip (Suzhou Medical Supplies Factory, specification 0.25×40mm), lifting and inserting and twisting, but not piercing the adhesive pad. The output wire of the special sham electroacupuncture apparatus is cut in the middle, and the appearance is as usual; that is, the electroacupuncture apparatus shows an on state, but is not actually energized; the electroacupuncture points, acupuncture time points, frequency, retention time, and duration of treatment are the same as the intervention group, and the patients are informed that it is an effective light current input and may not feel stimulation, but the current is output. All study patients will be treated independently and separately to ensure that patients will not come into contact with each other.

Routine perioperative management will be given, postoperative fluid and nutritional support, correction of acid-base imbalance, electrolyte disorders, anti-infection, hemostasis and other symptomatic management.

Acupoint: bilateral Hegu (LI4), Zhigou (SJ6), Zusanli (ST36), Shangjuxu (ST37). All acupoints will be taken by tonifying method after obtaining qi, and unilaterally connected to an electroacupuncture instrument for electrical stimulation with a continuous wave frequency of 5 Hz and a stimulation intensity as tolerated by the patient for 30 min each time. Acupuncture stimulation was given every 12 h. The duration of treatment was from postoperative to the fourth postoperative day (d0-d4) or until the patient's first postoperative anal exhaust or until the fourth day.

Electroacupuncture group

Sham acupuncture needle will have the same appearance as the traditional needle, with a blunt tip (Suzhou Medical Supplies Factory, specification 0.25×40mm), lifting and inserting and twisting, but not piercing the adhesive pad. The output wire of the special sham electroacupuncture apparatus is cut in the middle, and the appearance is as usual; that is, the electroacupuncture apparatus shows an on state, but is not actually energized; the electroacupuncture points, acupuncture time points, frequency, retention time, and duration of treatment are the same as the intervention group, and the patients are informed that it is an effective light current input and may not feel stimulation, but the current is output.

Sham EA group

Ke Wang

Jia Zhou, M.D.

The goal of this clinical trial is to verify the efficacy of electroacupuncture in accelerating the recovery of gastrointestinal function after colorectal cancer surgery. The main questions it aims to answer are:

* Whether electroacupuncture can accelerate the recovery of gastrointestinal function in patients after colorectal cancer surgery.
* Whether electroacupuncture intervention is safe for postoperative colorectal cancer patients.

Participants will be randomized into 3 groups:

The conventional control group will receive postoperative rehydration and nutritional support, correction of acid-base imbalance and electrolyte disturbance, anti-infection, hemostasis and other symptomatic treatments.

In the electroacupuncture group, acupuncture will be performed within 6 hours after surgery on the basis of the conventional control group. Acupoint: bilateral Hegu (LI4), Zhigou (SJ6), Zusanli (ST36), Shangjuxu (ST37). Both after obtaining Qi, and unilaterally connected to the electroacupuncture instrument for electrical stimulation, the current frequency is continuous wave 5 Hz, the intensity of stimulation was as the patient tolerated, each time lasting 30 min. Acupuncture stimulation was given every 12 h. The course of treatment was terminated postoperatively until the fourth postoperative day (d0-d4) or until the patient showed the first postoperative anal exhaust or continued until the fourth day.

The sham acupuncture group will based on the conventional control group, using a blunt-tipped needle tip that do not pierce the adhesive pad.

Colorectal cancer is the most common and predominant malignancy, and radical resection surgery, as the main method of current treatment for colon and gastrointestinal cancers, is performed on a large number of patients each year. Clinically, abdominal surgery causes the highest frequency of gastrointestinal dysfunction and the longest relative duration of dysfunction. A condition in which gastrointestinal function has not fully recovered after abdominal surgery is called gastrointestinal dysfunction. The common symptoms of postoperative gastrointestinal dysmotility are abdominal distension, abdominal pain, nausea and vomiting, diminished or even absent bowel sounds, loss of anal discharge, loss of bowel movements, and even secondary symptoms such as fever and pulmonary infection. It will adversely affect patients' postoperative quality of life to varying degrees, weaken their gastrointestinal barrier capacity, and severe gastrointestinal dysfunction can lead to complications such as electrolyte disorders, intestinal adhesions, intestinal obstruction, anastomotic fistula, and abdominal wall incision dehiscence in patients, as well as increase the social burden and the economic burden of patients. Some clinical reports show that acupuncture has good efficacy on gastrointestinal dysfunction, and acupuncture has effects on the gastrointestinal tract such as promoting gastrointestinal motility and reducing the inflammatory response of the gastrointestinal tract. In this study, a multicenter, randomized, blinded, sham acupuncture-controlled clinical design will be used to verify the efficacy of postoperative electroacupuncture in accelerating the recovery of gastrointestinal function after colorectal cancer surgery.

Participants will be randomized into 3 groups:

The conventional control group will receive postoperative rehydration and nutritional support, correction of acid-base imbalance and electrolyte disturbance, anti-infection, hemostasis and other symptomatic treatments.

In the electroacupuncture group, acupuncture will be performed within 6 hours after surgery on the basis of the conventional control group. Acupoint: bilateral Hegu (LI4), Zhigou (SJ6), Zusanli (ST36), Shangjuxu (ST37). Both after obtaining Qi, and unilaterally connected to the electroacupuncture instrument for electrical stimulation, the current frequency is continuous wave 5 Hz, the intensity of stimulation was as the patient tolerated, each time lasting 30 min. Acupuncture stimulation was given every 12 h. The course of treatment was terminated postoperatively until the fourth postoperative day (d0-d4) or until the patient showed the first postoperative anal exhaust or continued until the fourth day.

The sham acupuncture group will based on the conventional control group, using a blunt-tipped needle tip that do not pierce the adhesive pad. In other words, the electroacupuncture instrument show the state of being connected, but it is not actually energized; the acupuncture points, acupuncture time points, frequency, retention time and treatment duration were the same as those of the intervention group.

Needles: Huatuo brand disposable acupuncture needles φ0.25×40mm (1.5 inch); needles are purchased from Suzhou Medical Supplies Factory Co.

Acupoint: bilateral Hegu (LI4), Zhigou (SJ6), Zusanli (ST36), Shangjuxu (ST37), lasting 30 min each time.

Postoperative electroacupuncture stimulation method: all acupoints will be taken by tonifying method after obtaining qi, and unilaterally connected to the electroacupuncture instrument for electrical stimulation with a continuous wave frequency of 5 Hz and a stimulation intensity as tolerated by the patient for 30 min each time. Acupuncture stimulation will be given every 12 h. The duration of treatment was from postoperative to the fourth postoperative day (d0-d4) or until the patient's first postoperative anal discharge or until the fourth day.

Both groups will use adhesive pads, and the sham acupuncture needle will have the same appearance as the traditional needle, with a blunt tip (Suzhou Medical Supplies Factory, specification 0.25×40mm), lifting and inserting and twisting, but not piercing the adhesive pad. The output wire of the special sham electroacupuncture apparatus is cut in the middle, and the appearance is as usual; that is, the electroacupuncture apparatus shows an on state, but is not actually energized; the electroacupuncture points, acupuncture time points, frequency, retention time, and duration of treatment are the same as the intervention group.

All study patients will be treated independently and separately, ensuring that patients will not come into contact with each other. To test the effectiveness of blinding of participants, two hospitals will be selected from for blinded success assessment.

Electroacupuncture (EA) Promotes Gastrointestinal Functional Recovery After Radical Colorectal Cancer Surgery

Electroacupuncture Promotes Gastrointestinal Functional Recovery After Radical Colorectal Cancer Surgery: a Multicenter Randomized Controlled Study

All individual participant data that underlie results in a publication.

The time between the patient's first exhaust and the end of surgery will be recorded.

Patients self-report their defecation and doctors record the time.

Monitoring by continuous auscultation recorder of bowel sounds immediately at the end of surgery; Determination of recovery of postoperative bowel sounds: the time point when regular bowel sounds are observed and greater than 4 times/minute, calculate its time until the end of surgery (h), this outcome is only used in our center.

The time when the patient first entered water after surgery was recorded separately.

During the postoperative hospitalization, whenever nausea, vomiting and abdominal distension occur, patients or their family members use the uniform tabulation to record the occurrence time by themselves and inform the medical staff in time, and the medical staff keep records at the same time. The time until the end of the operation and the number of postoperative episodes will be calculated before discharge.

Version 3.0 European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), standard score, range from 0 to 100, higher scores mean a better outcome.

Short Form 12 scale (Chinese version). (Short Form 12 scale consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability).

Visual analogy score (0 to 5, higher scores mean a worse outcome)

Calculate and record the number of days from the day of surgery to the day of patient discharge.

Hypersensitive C-reactiveprotein (hs-CRP), μg/L.

ShuGuang Hospital

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai Baoshan hospital of Integrated Traditional Chinese and Western Medicine

Shanghai Yueyang Integrated Medicine Hospital

Infections

Symptoms and General Pathology

Communicable Diseases

Fistula

Pancreatic Diseases

Bile Duct Diseases

Digestive System Fistula

Pathological Conditions, Anatomical

Biliary Tract Diseases

Anti-Infective Agents

Central Nervous System Depressants

Ethanol

Procedures that will be captured include:

EUS- ERCP, Endoscopic Hepatology - EUS, EUS-Coils placement, EUS Glue injection, EUS-Fiducial placement, EUS-Neurolysis, EUS-Stent placement, EUS-alcohol injection, EUS-guided Ablation, EUS-guided anastomosis, EUS Guided ERCP for gallbladder, pancreatic duct or biliary duct drainage, EUS guided - Hemostasis, EUS guided- Therapy for cancer or premalignant lesion (Injection, neurolysis, fiducial, aspiration, RFA ), EUS - Fluid Collection, abscess or cavity drainage, EUS - Guided Ductal Drainage, EUS - Guided Anastomosis

Therapeutic Endoscopic Ultrasound or Interventional Endoscopy for Gastrointestinal Indications

Therapeutic Endoscopic Ultrasound

Michel Kahaleh, MD

The purpose of this retrospective chart-review registry study is to evaluate the safety profile, efficacy profile and cost-effectiveness of the various therapeutic endoscopic ultrasound (EUS) procedures (for benign and malignant gastrointestinal disorders).

1. To assess the clinical and technical success rates of EUS-Guided interventions
2. To document the impact of therapeutic EUS procedures on the management of gastrointestinal disorders including malignancies through cost effective analyses.
3. Compare endoscopic interventions to non-endoscopic interventions for the same clinical indications and evaluate safety and efficacy.

Our tertiary-care institution performs clinically-indicated therapeutic Endoscopic Ultrasound (TEUS) guided interventions, including biliary and pancreatic drainage, for both malignant and benign gastrointestinal indications in more than 2000 patients annually.

Procedures such as biliary and/or pancreatic sphincterotomy, stents placement (metallic or plastic) and removal for revision, cysts and pseudocysts drainage are conducted in patients suffering from pancreatico-biliary disorders, gastrointestinal disorders and esophageal disorders.

TEUS procedures are less invasive approach than surgery. Moreover, they can be available to patients who are ineligible for surgery or who have refused more aggressive surgical intervention.

They improve quality of life and extend survival duration.

Currently, there is limited multi-center data on therapeutic endoscopy clinical outcomes and standardized treatment algorithms in western populations. Due to continuing variations in therapeutic EUS procedures, as well as introduction of some TEUS procedure accessories; it is necessary to periodically evaluate the efficacy and safety of specific TEUS procedures and accessories for several indications to check for improved clinical outcomes.

Evaluation of these clinical details would help us compare them to conventional treatment modalities within our current facility and scope of practice; and consequently, help us identify safe and cost-effective treatment techniques, develop treatment algorithms and improve clinical management of patients at RWJMS and other tertiary-care centers.

Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry Study

Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry

Data will not be made available to other out-of-site researchers

Type, frequency and intensity of adverse events

Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University

Inflammatory Bowel Diseases

Ileus

Gastroenteritis

Patients undergoing elective colorectal procedures with an Enhanced Recovery Program. Orthogonal polarization spectral (OPS) imaging will be used to measure sublingual microcirculation

orthogonal polarization spectral (OPS) imaging allows noninvasive observation of human microcirculation in all accessible tissue surfaces

orthogonal polarization spectral (OPS) imaging

Gabriele Baldini, MD, MSc

The aim of this pilot study is to establish if a correlation between sub-lingual microcirculation measured by Orthogonal polarization spectral (OPS) imaging and symptoms of postoperative ileus exist in patients undergoing elective colorectal surgery.

AIM OF THE STUDY This observational study will assess whether perioperative microcirculatory changes can be correlated with symptoms associated with primary POI.

PRIMARY RESEARCH QUESTION Is there a correlation between peri-operative microcirculatory flow measurements and the incidence of symptomatic primary POI?

SECONDARY RESEARCH QUESTIONS

1. Is there a correlation between peri-operative microcirculatory flow measurements and the duration of symptomatic primary POI?
2. If any correlation is observed, which anatomic location (sublingual mucosa vs bowel serosa) yields microcirculatory flow measurements that are more strongly associated with the incidence and/or duration of symptomatic primary POI?
3. Can either intraoperative sublingual mucosa or intraoperative bowel serosa microcirculatory flow measurements predict symptoms of primary POI? Are these two anatomic locations equivalent in their ability to predict this complication?

Sublingual Microcirculation and Postoperative Ileus

Correlation Between Sublingual Microcirculation and Postoperative Ileus Symptoms in Patients Undergoing Colorectal Surgery - a Pilot Study

Patients will be considered having POI symptoms if at least one symptom, for each of the following criteria, will be reported:

i. Vomiting (+/- nausea) OR abdominal distension AND ii. Absence of passing gas/stool OR not tolerating oral diet.

Microvascular flow index (MFI) score: this score is based on determination of the predominant type of flow observed. Flow is characterized as absent (0), intermittent (1), sluggish (2), or normal (3).

Gabriele Baldini, MD, MSc, Assistant Professor

Assitant Professor

Rare Diseases

Esophageal Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Participants received routine care and acupressure.

In the experimental group, routine nursing care and acupressure (Neiguan and Zusanli points) were performed from the 1st to the 5th day after the postoperative transfer from the ward to the hospital room. Twice a day, 3 minutes each time, 12 minutes in total.

acupressure

Chia-Chen Chen

This study is a quasi-experimental design clinical trial with the primary objective of comparing the health status of patients with esophageal cancer. Participants were divided into an experimental group and a control group. Patients in the experimental group received routine care and acupressure for 5 consecutive days starting from the day after entering the ward after esophageal cancer surgery, in the control group, participants received routine care, and Participants were assessed on the Gastrointestinal Symptom Distress Scale at the end of the intervention. The aim of this study was to verify the effectiveness of acupressure in improving of gastrointestinal symptoms distress after esophageal cancer surgery.

Esophageal cancer is one of the common and highly fatal malignant tumors, and its incidence rate is increasing every year, and most of them are in the middle and advanced stages when diagnosed. Surgery is the standard treatment for the eradication of esophageal cancer, which can effectively reduce the mortality rate and improve the survival rate, but the patients often experience gastrointestinal discomfort after surgery, which impedes the intake of nutrients and the body's recovery. The purpose of this study was to investigate the effectiveness of acupressure in improving the postoperative gastrointestinal discomfort in patients with esophageal cancer. An experimental study design was adopted, and patients were assigned to the experimental group and the control group in a time-divided manner. The experimental group was assigned to the experimental group and the control group in a time-separated manner. The experimental group received regular care from the first day to the fifth day after the patients were transferred from the intensive care unit to the hospital ward after the surgery, and they received acupressure at the Neiguan point of the upper limbs and the four acupoints of the foot Sanli of the lower limbs twice a day for 3 minutes each, for a total of 12 minutes; while the control group received regular care in the first day of the study. In this study, the gastrointestinal symptoms of the experimental group before and after acupressure were collected and compared with those of the control group, in order to verify the effectiveness of acupressure in improving gastrointestinal symptoms during postoperative nutritional support for jejunostomy.

Participants were divided into an experimental group and a control group. experimental group: received acupressure for 5 days in addition to regular care.

control group: received regular postoperative care.

The Effects of Acupressure on Improving Postoperative Gastrointestinal Symptom Distress in Esophageal Cancer Patients

The Gastrointestinal Symptom Distress Scale is a validated self-report tool that assesses 10 gastrointestinal symptoms that patients with esophageal cancer may face after surgery. The 10-question questionnaire measures the self-perceived severity of nausea, vomiting, satiety, bloating, abdominal cramps, acid reflux, chest tightness, heart burn, diarrhea, and constipation, as well as the degree of interference with life. Using an 11-point Likert scale, 0 points (never happened), 1 point (very slight/very slight interference), 10 points (very severe/extreme interference), and the total score of the scale is 0-100 points.

The higher the measured score, the more severe the gastrointestinal discomfort symptoms are and the more they interfere with life.

The Gastrointestinal Symptom Distress Scale was subjected to an expert validity review, using the CVI (content validity index) calculation method, and the score was above 0.80.

CHEN, CHIA-CHEN

Principal Investigator

Other Dietary Supplements

Acidophilus

Bifidobacterium

Participants will be given a 12-week supply of the probiotic supplement and asked to take 1 capsule daily by mouth at the same time as their first meal of the day.

Participants will be given a 12-week supply of the placebo capsules and asked to take 1 capsule daily by mouth at the same time as their first meal of the day.

The probiotic capsule contains Lactobacillus and Bifidobacterium strains, ingested orally once daily.

Multistrain Probiotic

Placebo is composed of maltodextrin, that is an identically formulated and packaged inactive substance

Placebo

Linda E Carlson, PhD

Julie M Deleemans, PhD

Purpose: The goal of this clinical trial is to determine whether probiotics can reduce gastrointestinal and psychosocial symptoms in post-treatment cancer survivors by impacting the gut microbiome.

Objectives: The main questions the investigators aim to answer are:

* Does taking the probiotic reduce gastrointestinal (e.g. belly pain) and psychosocial (e.g. depressive symptoms, fatigue) symptoms, and impact the gut microbiome?
* What relationships exist between gut bacteria, gastrointestinal, and psychosocial symptoms?

Methods: The study team will investigate this by giving a group of adult post-treatment cancer survivors either a probiotic capsule (intervention) or placebo capsule (control) over 12 weeks. Investigators will then analyze the bacterial diversity in participants' stool samples before and after these 12 weeks to see how the bacterial composition changed due to the treatment. Surveys will be used to ask participants questions about their physical and mental health, including specific gastrointestinal and psychosocial symptoms.

Implications: Cancer recovery is tough enough, and to minimize treatment-related long-term effects through a simple probiotic capsule would immensely improve the well-being and health of survivors.

Background: Survivors of cancer experience chronic gastrointestinal (GI) and psychosocial health symptoms, and reduced gut microbial diversity. This may compromise survivors' long-term health and overall wellbeing. No studies have investigated probiotics for managing both GI and psychosocial symptoms together, or the composition of the gut microbiota in post-treatment cancer survivors.

Aims: To investigate the effects of a probiotic vs. placebo on (i) abdominal pain and depressive symptoms (primary outcomes); (ii) (a) GI (i.e. gas/bloating, diarrhea, constipation) and psychosocial (i.e. anxiety, cognitive function, fatigue) symptoms, and general health; and (b) gut microbiota composition; (iii) relationships between bacteria, GI and psychosocial symptoms.

Methods: This double-blinded, placebo-controlled, 2-arm, randomized trial will recruit N=66 participants allocated to the probiotic or placebo group for a 12-week trial. Adult survivors diagnosed with a solid tumour or blood cancer who have completed chemotherapy within the last 5 years, and show elevated GI or psychosocial symptoms will be included. The probiotic capsule contains Lactobacillus and Bifidobacterium strains, ingested orally once daily. Stool samples will be collected at baseline and week-12 and analyzed using GA-Map dysbiosis test and 16S rRNA gene sequencing. GI and psychosocial surveys will be completed at baseline, weeks 6 and 12. Descriptive statistics, frequencies, paired samples t-tests, linear mixed models, and Spearman's correlations analyses will be used.

Implications: This study explores a novel, microbiota-based treatment for chronic GI and psychosocial symptoms in cancer survivors. These findings and commitment to patient-centred knowledge translation via creating patient materials (e.g. infographics, personal results summary) will enable patients to make informed decisions about their health.

Theoretical Framework: This line of research follows the NIH ORBIT model for intervention development. Briefly, the ORBIT model provides a generic, systematic framework that emphasizes using a set of studies to form a chain of evidence that ultimately indicates readiness for an efficacy trial.

Study Design. Consistent with the National Institutes for Health (NIH) clinical trial phases for drug development, this study will fit into phase II, where investigators are focused on examining treatment effectiveness. A placebo-controlled randomized double-blinded study design is the gold standard for intervention research involving medications or natural health products, such as probiotics.

Participants will be randomized individually upon enrollment after completing baseline assessments into the probiotic or placebo condition in a 1:1 allocation ratio using a computer-generated stratified randomization strategy (to balance age and sex). Randomization sequence will be pre-determined by randomization software and sequential allocations prepared in sealed envelopes, only to be revealed to a research assistant after consent and baseline questionnaires are completed. Once randomized, a research assistant will be responsible for assigning the probiotic or placebo for each participant to their study package so that the study coordinator, who will have direct contact with patients, will remain blinded to participants' condition. A member of the study team who does not have contact with participants will also be provided a copy of the treatment allocation.

The Chemo-Gut Probiotic Trial for Cancer Survivors

The Chemo-Gut Trial: A Double-blind Randomized Controlled Trial Investigating the Effects of a Multi-strain Probiotic on Gut Microbiota, Gastrointestinal Symptoms, and Psychosocial Health in Cancer Survivors

The study protocol will be published. Deidentified data will be made available to other researchers after primary data has been published and upon reasonable request to the PI.

Measure: Scores for symptom outcomes will be correlated with bacterial operational taxonomic units (ASVs) using Spearman's rho for non-parametric data

Endpoint: Clinically meaningful effects will be defined as reductions of 3 points or more from baseline scores of abdominal pain symptoms on PROMIS measures.

Measure: PROMIS Belly Pain - Scale v1.0, 5a; Scores range from 20 to 80. Higher scores \>60 indicate more symptoms.

Endpoint: Clinically meaningful effects will be defined as reductions of 3 points or more from baseline scores of depression on PROMIS measures.

Measure: PROMIS Ca Item Bank v1.0 - Emotional Distress - Depression questionnaire; Scores range from 20 to 80. Higher scores \>60 indicate more symptoms.

Endpoint: Effects of probiotics on: Gas/bloating Measure: PROMIS Gas and Bloating - Scale v1.1 13a

Endpoint: Effects of probiotics on: Diarrhea Measure: PROMIS Diarrhea - Scale v1.0, 6a

Endpoint: Effects of probiotics on: Constipation Measure: PROMIS constipation - Scale v1.0, 9a

PROMIS Anxiety: v1.0 - Anxiety - Short Form 8a; Scores range from 20 to 80. Higher scores \>60 indicate more symptoms.

PROMIS v1.0 - Fatigue - Short Form 8a. Scores range from 20 to 80. Higher scores \>60 indicate more symptoms.

Measure: PROMIS v2.0 - Cognitive Function; Scores range from 80 (high function) to 20 (severe dysfunction).

Measure: PROMIS Global Health - Scale v1.2; Scores range from 80 (Excellent health) to 20 (Poor health).

Measure: Chao1, Shannon, and Simpson index for statistically significant differences in alpha diversity between groups

Measure: Bray-Curtis index for statistically significant differences in beta diversity between groups

Measure: statistically significant differences in differential taxonomic abundance (ASV's) between groups

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Construction and Validation of Risk Prediction Model for Gastrointestinal Dysfunction of Patient With Colorectal Cancer	NCT05891301	Patient With Co... Surgery	Questionnaires ...	18 Years -	Sun Yat-sen University
Bolus Pouch Feed Study	NCT05822557	Cancer Neurological Di... Gastrointestina... Oral Complicati... Stroke	Bolus Pouch Fee...	16 Years - 100 Years	Nutricia UK Ltd
Construction and Validation of Risk Prediction Model for Gastrointestinal Dysfunction of Patient With Colorectal Cancer	NCT05891301	Patient With Co... Surgery	Questionnaires ...	18 Years -	Sun Yat-sen University
Electroacupuncture (EA) Promotes Gastrointestinal Functional Recovery After Radical Colorectal Cancer Surgery	NCT06128785	Colorectal Canc... Gastrointestina...	Electroacupunct... Sham EA group	18 Years - 79 Years	Shanghai Yueyang Integrated Medicine Hospital
Therapeutic Endoscopic Ultrasound for Gastrointestinal Disorders: A Multicenter Registry Study	NCT05051358	Therapeutic End... Advanced Endosc... Therapeutic End... Interventional ... Interventional ... Gastro-Intestin... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Gastrointestina... Pancreatic Dise... Bile Duct Disea...	Therapeutic End...	-	Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
Sublingual Microcirculation and Postoperative Ileus	NCT01828047	Colorectal Canc... Inflammatory Bo... Gastrointestina...	orthogonal pola...	18 Years -	McGill University Health Centre/Research Institute of the McGill University Health Centre
Bolus Pouch Feed Study	NCT05822557	Cancer Neurological Di... Gastrointestina... Oral Complicati... Stroke	Bolus Pouch Fee...	16 Years - 100 Years	Nutricia UK Ltd
The Effects of Acupressure on Improving Postoperative Gastrointestinal Symptom Distress in Esophageal Cancer Patients	NCT06275165	Esophageal Canc... Gastrointestina...	acupressure	18 Years - 85 Years	Chang Gung Memorial Hospital
The Chemo-Gut Probiotic Trial for Cancer Survivors	NCT06088940	Cancer Psychosocial Pr... Gastrointestina...	Multistrain Pro... Placebo	18 Years -	University of Calgary
The Chemo-Gut Probiotic Trial for Cancer Survivors	NCT06088940	Cancer Psychosocial Pr... Gastrointestina...	Multistrain Pro... Placebo	18 Years -	University of Calgary

Spots Global Cancer Trial Database for gastrointestinal dysfunction