Behaviors and Mental Disorders

All Conditions

Quality of Life

specific preoperative education program realised by a specialized stoma-therapist containing individualized information on material maintenance, hygiene, nutrition, complications, activities of daily life and occupation

standard preoperative education program administered by a surgeon containing information on surgery, outcome, risks and alternatives

Verbal education prior tu surgery administered to all patients in order to inform about the surgery and outcomes

Education program

Stefan Berkhoff, MD

Stefan Berkhoff, Doctor

Ulrike Wauer, MD

Beate Mantz

Patients with colorectal cancer prior to stoma surgery are randomized to different preoperative education programs: (a) specific preoperative education, (b) standard preoperative education. Outcome measures are quality of life, period of hospitalization and complication rates.

The present study is initiated to evaluate quality of life, period of hospitalization and complication rates in patients with colorectal cancer receiving treatment with stoma surgery. Prior to surgery patients are randomized to different preoperative education programs. In Arm A patients receive a new specific education program (Krankenhaus Nordwest concept) conducted by a specialized therapist (stoma-therapist). In Arm B patients receive the standard preoperative education program. Standardized questionnaires are used to evaluate quality of life and period of hospitalization at baseline and four weeks after surgery in Arm A vs. Arm B

Evaluation of Quality of Life and Period of Hospitalization by Education

Clinical Trial to Evaluate Quality of Life, Period of Hospitalization and Complication Rates in Patients With Stoma Receiving Specific Preoperative Education vs. Standard Preoperative Education

Quality of life is assessed with EORTC QLQ-30 and EORTC QLQ-CR 29 at baseline, 9-15 days after surgery and 4 weeks after surgery. An improvement in Arm A is characterized by 10 points

Krankenhaus Nordwest

Symptoms and General Pathology

Neoplasms

Digestive System Diseases

Hernia

Incisional Hernia

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Pathological Conditions, Anatomical

Postoperative Complications

Biologic mesh placed in retromuscular position

Synthetic mesh placed in retromuscular position

Biologic mesh placed in retromuscular position during ileostoma closure

Biologic Mesh

synthetic mesh placed in retromuscular position during ileostoma closure

Synthetic Mesh

Leon Maggiori, MD

This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after total mesorectal excision (TME) for rectal cancer

This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after TME for rectal cancer.

Patients are randomized in 3 groups : no mesh, synthetic mesh (Parietex, Covidien), biologic mesh (Cellis, Meccelis). Meshes are placed in retromuscular position after diverting ileostomy closure.

Primary endpoint is radiological incisional hernia rate, assessed on CT-scan, at the end of follow-up Secondary endpoints include postoperative morbidity, postoperative pain, postoperative quality of life, long-term clinical incisional hernia rate.

Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery

Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery: A Randomized-controlled Trial

Primary endpoint is radiological incisional hernia rate, assessed on CT-scan, at the end of follow-up.

Statistical analysis will be performed as soon as follow-up reach 12 months for last included patient

Clinical incisional hernia rate : Statistical analysis will be performed as soon as follow-up reach 12 months for last included patient

Assistance Publique - Hôpitaux de Paris

Colonic Diseases

Protective ileostomy as a defunction mean after low anterior resection

Protective transverse colostomy as a defunction mean after low anterior resection

Protective loop ileostomy after low anterior resection

Ileostomy

Protective loop transverse colostomy after low anterior resection

Transverse colostomy

Yanlei Ma, PhD

Yichi Zhang, MD

Exploring the effect of protective ileostomy compared with transverse colostomy on the occurrence of complications, the occurrence of serious side effects of adjuvant chemotherapy and disease recurrence in patients with low rectal cancer after radical surgery from the perspective of intestinal microecology.

Low rectum refers to the rectal area \<7 cm from the anal verge. At present, with the development of modern medical technology and the change of surgical concept, more and more patients can achieve the goal of radical treatment of low rectal cancer while preserving the anus. The occurrence of anastomotic leakage after anus-preserving surgery for low-grade rectal cancer is a more common and serious complication, with an incidence ranging from 2.4% to 15.9%, and the morbidity and mortality rate after anastomotic leakage can be as high as 16%.

A protective stoma protects the anastomosis by temporarily establishing an artificial channel above the anastomosis to divert feces and avoid mechanical pressure and contamination of the anastomosis by intestinal contents, allowing the anastomosis to grow and heal in relatively clean external conditions. The current choices of protective stoma sites are terminal ileum and transverse colon. Analysis of domestic and international studies shows that both protective transverse colostomy and ileostomy can achieve the effect of diversion of stool, but whether there is a difference in preventing anastomotic leakage and reducing adverse outcomes of anastomotic leakage remains to be investigated. There are significant inconsistencies between domestic and international studies regarding the incidence of stoma-related complications caused by different stoma sites: the study by Rondelli et al. showed that terminal ileostomy was associated with lower stoma-related complications, and a domestic meta-analysis recommended terminal ileostomy after radical rectal cancer surgery. In contrast, the study by the team from the Union Hospital showed that transverse colostomy was associated with significantly lower rates of stoma-related complications and perioperative complications of stoma reentry.

In addition, according to the Union Hospital team study, the incidence of postoperative intestinal microbiota dysbiosis was higher in patients who underwent ileostomy compared to those who underwent transverse colostomy. The total intestinal microbiota in the colon accounts for more than 90% of the systemic intestinal microbiota, and the intestinal microbiota in the large intestine can be roughly restored to preoperative levels after transverse colostomy, whereas a large amount of intestinal microbiota is lost and difficult to restore after ileostomy. The dominant flora in the colon, such as Clostridium and Enterococcus, are less likely to colonize the small intestine, which may adversely affect the intestinal and systemic immune regulation and antitumor immune effects of the body. In addition, patients with progressive low-grade rectal cancer routinely require adjuvant chemotherapy after radical surgery, and there are no studies at domestic or abroad on whether terminal ileostomy, which is more common than transverse colostomy for intestinal dysbiosis, has any differences on the efficacy and toxic side effects of adjuvant chemotherapy for patients; furthermore, it is also important to investigate whether the two different stoma methods have an impact on long-term disease recurrence and overall survival of patients. In addition, whether the two different stoma modalities have an effect on long-term disease recurrence and overall survival is also an important research question.

Therefore, the investigators propose to conduct a prospective, randomized, controlled study in patients with low-grade rectal cancer who underwent radical surgery (with or without neoadjuvant radiotherapy) to investigate whether there are differences in the incidence of complications, serious side effects of adjuvant chemotherapy, and disease recurrence after terminal ileostomy versus transverse colostomy from the perspective of intestinal microecology, and to explore the differences in systemic immunity, inflammatory, and metabolic status.

Postoperative Effects of Different Enterostomy Approaches

A Single-centre, Randomized Study to Compare the Outcomes of Protected Transverse Colostomy Versus Ileostomy After Low Anterior Resection of Low Rectal Cancer From the Perspective of Intestinal Microecology

Determining the structural impact of different stoma methods on intestinal microecology by metagenomic sequencing

Measurement of plasma inflammatory markers such as IL-6, TNF-α, CRP and PCT

Estimation of dynamics of cellular immunity as measured by the proportion of CD3+, CD4+, CD8+, CD4+CD25+CD127low, CD16+CD56+ cells using flowcytometry

Estimation of dynamics of humoral immunity as measured by the proportion of CD3-CD19+, CD20+ cells using flowcytometry

The occurrence of postoperative anastomotic leakage

Incidence of postoperative complications such as diarrhea, intestinal obstruction, incisional infection, stoma prolapse, stoma necrosis, parastomal hernia, irritant dermatitis, renal insufficiency, etc.

Documenting the patient's post-operative recovery

Assessed with Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Assessed with European Organization for Research and Treatment of Cancer high-dose chemotherapy specific quality of life questionnaire module (EORTC QLQ-HDC29), ranging from 29 to 116 and higher scores suggest worse quality of life

Time between the start of surgical randomization and recurrence of disease or death (from any cause)Time between the start of surgical randomization and recurrence of disease or death (from any cause)

Time from the start of surgical randomization to death (from any cause)

Fudan University

Chief Physician

Carcinoma

Colonic Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Herbal and Botanical

All Drugs and Chemicals

Cola

Resection

Stoma

seeking to identify risk factors leading to mortality in obstructed left cancer colon

Risk Factors for Mortality in Cases of Obstructed Left Colonic Carcinoma

Mansoura University

After the participant consented to participate in the study with the Informed Consent Form, her comfort level was measured with the Postpartum Comfort Scale.

A session of NLP (30 minutes) was applied to the participant. The patient was informed about the application. The mother was asked to sit or lie down i Before the discharge of the participant from the hospital, her comfort level was evaluated once again by using the Postpartum Comfort Scale

After the participant consented to participate in the study with the Informed Consent Form, her comfort level was measured with the Postpartum Comfort Scale.

Without having any additional practice, the participant solely had the routine clinical protocol.

Before the discharge of the participant from the hospital, her comfort level was evaluated once again by using the Postpartum Comfort Scale.

The new behavior creation technique of NLP is based on the argument that the imagination process and reality are recorded in the same way in the brain.

Using the Participant's eye movements and imagination . He will be asked to imagine himself while caring for the stoma. participient will then be asked to re-enact the process with the correct stages of stoma care and the jurals that must be adhered to in order to successfully care for it.

Questions will be asked about where he can find the support he needs to carry out this process successfully. At the end of this whole process, he will be expected to construct what life is like with a stoma.The technique will be applied to the patient once and will be instructed to remember this successful process every time he or she feels distressed about the stoma.

At the end of 6 months, the quality of life and compliance will be evaluated by asking the scale questions again.

Neuro-Linguistic Programming Techniques

The aim of this study is to examine the effect of NLP techniques on stoma compliance and quality of life in patients with stoma.

The study will be conducted using a prospective randomized controlled single-blind clinical trial model.

The research will consist of patients with temporary or permanent colostomy/ileostomy, who are hospitalized in Mersin City Training and Research Hospital.

Research data will be obtained with demographic questionnaire, Adjustment Scale for Individuals with Ostomy and Stoma Quality of Life Scale.

Analysis of the study data will be done through the IBM SPSS Statistics 26 package program. While evaluating the study data, frequencies (number, percentage) for categorical variables and descriptive statistics (mean, standard deviation) for numerical variables will be given.

Statistical significance in the analyzes will be interpreted at the 0.05 level.

Stomas are formed in order to provide stool output after surgery in cases that require removal of the bowel due to disease or trauma (Harputlu \& Özsoy, 2016). Stoma surgery is a vital surgical intervention. However, the individual may have to cope with many problems that may negatively affect the adaptation process and quality of life in terms of living with a stoma. The literature is that despite the developing stoma products and professional nurse educators, the problems related to stoma compliance and quality of life of the patients continue, and complications affecting coping with these processes are seen at different rates.

The aim of this study is to examine the effect of NLP techniques on stoma compliance and quality of life in patients with stoma.

The study will be conducted using a prospective randomized controlled single-blind clinical trial model.

The study will consist of patients with temporary or permanent colostomy/ileostomy, who are hospitalized in Mersin City Training and Research Hospital.

Research data will be obtained with demographic questionnaire, Adjustment Scale for Individuals with Ostomy and Stoma Quality of Life Scale.

Analysis of the study data will be done through the IBM SPSS Statistics 26 package program. While evaluating the study data, frequencies (number, percentage) for categorical variables and descriptive statistics (mean, standard deviation) for numerical variables will be given.

The normality assumptions of the numerical variables according to the groups were examined with the Kolmogorov Smirnov test of normality and it was observed that the variables were normally distributed. For this reason, parametric statistical methods will be used in the study.

Relationships between two independent categorical variables were interpreted by Chi-square analysis. The differences between the two independent groups were examined using the Independent Sample T Test. The differences between the two dependent numerical variables will be examined with Dependent Sample T. Statistical significance in the analyzes will be interpreted at the 0.05 level.

NLP techniques will be applied to the experimental group, and no intervention will be applied to the control group.

Participants will not know they are in the experimental or control group

Cesarean Neuro Linguistic Programming Comfort

Effect of Neuro-Linguistic Programming on Comfort Level After Cesarean: A Random-ized Controlled Trial

One year after the study results were published in a scientific journal

At the end of the firsth day to measure the comfort level of the participants, the average score of the Individual with a postpartum comfort Scale will be calculated The General Comfort Questionnaire developed by Kolcaba (1992). Designed as a five-point Likert-type scale, the PCS has 34 items. In this respect, the participants respond to PCS items by rating them from 1 point to 5 points. In positively worded items, "I strongly agree" refers to the highest level of comfort whilst "I strongly disagree" points to the lowest level of comfort. Negatively worded items were reverse-coded. The minimum and maximum scores to be obtained from the PCS are successively 34 and 170 points. There is no cut-off point for the PCS. As the scores obtained from the PCS increase, the comfort levels also go up. Cronbach's alpha coefficient as the measure of internal consistency was found as 0.78 for the PCS

At the end of the 3th day to measure the comfort level of the participants, the average score of the Individual with a postpartum comfort Scale will be calculated The General Comfort Questionnaire developed by Kolcaba (1992). Designed as a five-point Likert-type scale, the PCS has 34 items. In this respect, the participants respond to PCS items by rating them from 1 point to 5 points. In positively worded items, "I strongly agree" refers to the highest level of comfort whilst "I strongly disagree" points to the lowest level of comfort. Negatively worded items were reverse-coded. The minimum and maximum scores to be obtained from the PCS are successively 34 and 170 points. There is no cut-off point for the PCS. As the scores obtained from the PCS increase, the comfort levels also go up. Cronbach's alpha coefficient as the measure of internal consistency was found as 0.78 for the PCS

Toros University

Assit. Prof.

Intestinal Obstruction

Neoadjuvant chemotherapy was administered 1 week after successful SEMS placement and decompression for patient with obstructing left-sided colonic cancer. Patients received either three cycles of mFOLFOX6 repeated every 2 weeks or two cycles of CAPOX repeated every 3 weeks. Elective surgery was performed 2 weeks after completion of chemotherapy by experienced colorectal surgeons.

self-expanding metallic stent placement followed by neoadjuvant chemotherapy

This study aimed to evaluate the safety and feasibility of SEMS followed by neoadjuvant chemotherapy prior to elective surgery for obstructing left-sided colon cancer.

Stoma is reported to be frequent in self-expanding metallic stent (SEMS) treated patients with obstructing left-sided colon cancer than in those with non-obstructing surgery. Retrospective study reported worse overall survival with SEMS and elective surgery than with emergency surgery in patients with left-sided malignant colon obstruction. In practice, intestinal wall edema following stent placement increases the difficulty of surgery, and this could be a major problem if the interval between stent insertion and surgery is short (1-2 weeks). The patients with obstructing left-sided colon cancer received SEMS treatment, and the recevied neoadjuvant chemotherapy prior to elective surgery.

SEMS Placement Followed by Chemotherapy and Surgery for Obstructing Left-sided Colonic Cancer

Self-expanding Metallic Stent Placement Followed by Neoadjuvant Chemotherapy and Scheduled Surgery for Treatment of Obstructing Left-sided Colonic Cancer

Beijing Chao Yang Hospital

Chairman of General Surgery

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Laryngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Laryngeal Diseases

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Otorhinolaryngologic Diseases

Laryngeal Cancer

Participants will be fitted to use a hand free HME device over their stoma in order to communicate with a voice prosthesis for one month. The participants will also serve as their own control performing voicing and speech tasks using digital occlusion and digital depression HME.

A voice prosthesis, SpeakFree HME Hands Free Valve, achieved with creation of a tracheoesophageal puncture will be placed over the stoma for 1 month.

SpeakFree HME Hands Free Valve

Using participant's own fingers, they will be putting their fingers over the stoma.

Digital Occlusion

A digital handheld press-down HME will be placed over stoma.

Digital Depression HME

Jerri Halgowich

Mario A Landera, SLP.D.

The purpose of the study is to evaluate the new Blom-Singer SpeakFree disposable hands free valve heat and moisture exchanger (HME). The investigators will compare the SpeakFree to other modalities of stomal occlusion (digital occlusion and digital depression of an HME) for patients who communicate with a voice prosthesis as determined by patient preference and satisfaction. In addition, the investigators will compare the SpeakFree to other modalities of stomal occlusion as determined by objective measures of speech and voice parameters (maximum phonation time, syllables per breath, minimum/maximum phonation pressures, and a clinician rating of voice quality using a visual analog scale).

SpeakFree Heat and Moisture Exchanger (HME)

Evaluation of a Disposable Hands-Free Heat and Moisture Exchanger (HME) Valve: The Blom-Singer SpeakFree HME Hands Free Valve

Patient preference and satisfaction will be measured using a visual Analog Scale (VAS) ranging in score from 1-10 with a higher score indicating greater satisfaction with the device.

Voice Quality will be measured using a visual Analog Scale ranging in score from 1-10 with a higher score indicating that the patient feels their voice quality is better with the device.

Maximum phonation time (MPT) is a clinical measurement of the longest time a person can phonate a vowel in seconds.

Participants' number of syllables per breath while reading a standardized reading passage will be measured and reported.

Minimal and maximal pressures will be reported using a manometer while the participant counts from 1 to 15.

The clinician will rate participant's voice quality using VAS. VAS has a total score ranging from 1 to 10 with the higher score indicating that the clinician feels that participant's voice quality is better with the device.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Quality of Life and Period of Hospitalization by Education	NCT02526264	Colorectal Canc...	Education progr...	18 Years -	Krankenhaus Nordwest
Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery	NCT02576184	Incisional Hern...	Biologic Mesh Synthetic Mesh	18 Years -	Assistance Publique - Hôpitaux de Paris
Postoperative Effects of Different Enterostomy Approaches	NCT05853094	Colorectal Canc... Colorectal Neop... Intestinal Neop...	Ileostomy Transverse colo...	18 Years - 80 Years	Fudan University
Risk Factors for Mortality in Cases of Obstructed Left Colonic Carcinoma	NCT04823416	Risk Factors fo...	Resection Stoma	18 Years -	Mansoura University
Cesarean Neuro Linguistic Programming Comfort	NCT05646537	Colorectal Canc...	Neuro-Linguisti...	18 Years - 50 Years	Toros University
SEMS Placement Followed by Chemotherapy and Surgery for Obstructing Left-sided Colonic Cancer	NCT04039360	Complication of...	self-expanding ...	18 Years - 80 Years	Beijing Chao Yang Hospital
Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery	NCT02576184	Incisional Hern...	Biologic Mesh Synthetic Mesh	18 Years -	Assistance Publique - Hôpitaux de Paris
SpeakFree Heat and Moisture Exchanger (HME)	NCT05349487	Laryngeal Cance... Laryngectomy	SpeakFree HME H... Digital Occlusi... Digital Depress...	18 Years -	University of Miami
Risk Factors for Mortality in Cases of Obstructed Left Colonic Carcinoma	NCT04823416	Risk Factors fo...	Resection Stoma	18 Years -	Mansoura University
SpeakFree Heat and Moisture Exchanger (HME)	NCT05349487	Laryngeal Cance... Laryngectomy	SpeakFree HME H... Digital Occlusi... Digital Depress...	18 Years -	University of Miami

Spots Global Cancer Trial Database for stoma

Every month we try and update this database with for stoma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for stoma

Every month we try and update this database with for stoma cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for stoma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.