Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

After discharge, the individuals in the experimental group were given training by the researcher through training booklets prepared by the Association of Wound Ostomy Incontinence Nurses and video conference in four interviews. The first interview was done on the 5th day after discharge, the second on the 10th day, the third on the 15th day, and the fourth on the 2nd month.

Individuals with stoma in the control group received the training of the company representative that sells stoma materials routinely in the hospital.

Educational booklets are given according to the type of stoma. The individual with the stoma was told that the researcher was always reachable by phone and could communicate if he had any problems. The individuals with stoma in the experimental group received the training of the company representative that sells stoma materials, which is routinely given in the hospital. After discharge, training was given by the researcher via video conference in a total of four interviews. The first interview was done on the 5th day after discharge, the second on the 10th day, the third on the 15th day, and the fourth on the 2nd month. A post-test was conducted at the end of the 4th training interview, which was administered via video conferencing.

At home education via video conferencing

Deniz HARPUTLU, PhD, RN

The aim of this study is to determine the effect of stoma care training given at home via videoconferencing after discharge on the self-efficacy and compliance with stoma of individuals with stoma. In addition to the main purpose, it is aimed to determine whether stoma care education given via video conference at home has an effect on individuals with stoma to perform their own stoma care.

After discharge, the individuals in the experimental group were given training by the researcher through training booklets prepared by the Association of Wound Ostomy Incontinence Nurses and video conference in four interviews. The first interview was done on the 5th day after discharge, the second on the 10th day, the third on the 15th day, and the fourth on the 2nd month. Individuals with stoma in the control group received the training routinely given in the hospital. Self-efficacy and compliance with stoma were measured at baseline and at 2 months. The ability to care for one's own stoma was evaluated at the end of the study.

This study is a parallel group randomized controlled study.

The Effect of Education on Self-Efficacy and Adaptation to Stoma of Individuals With Stoma

The Effect of Education Via Video Conferencing at Home on Self-Efficacy and Adaptation to Stoma of Individuals With Stoma

The Stoma Self-Efficacy Scale was developed to measure self-efficacy in individuals with stoma. The scale was developed by Bekkers et al. (1996). It is a 22-item scale with two sub-dimensions. Items in this scale are in 5-point Likert type. The first sub-dimension is the "Stoma Care Self-Efficacy" sub-dimension, which consists of the first 13 items. The second sub-dimension is the "Social Self-Efficacy" sub-dimension consisting of the remaining nine items. The minimum score that can be taken from the scale is 22, the maximum score is 110, and an increase in the score from the scale indicates high levels of self-efficacy. There is no reverse scored item in the scale.

It was created by Maekawa (2000) and later this scale was arranged by Simmons et al. (2009) in the form of Ostomy Adjustment Scale-23, consisting of 23 items and 4 sub-dimensions. OAS-23, a self-assessment scale, is a scale used to evaluate the level of adjustment in individuals with stoma. 4 sub-dimensions in this scale: accepting (includes items 1, 3, 4, 6, 9, 14, 15, 19, 23.), anxiety/worry (12, 13, 17, 20, 21 items) .), social cohesion (includes items 5, 7, 8, 11), and anger (includes items 2 and 10). At the same time, there are 3 items (16, 18 and 22) that are not included in any sub-dimensions. Each item of the scale is evaluated in a 5-point Likert type.

After the individuals with stoma in the experimental group were trained by the researcher throughout the study, it was evaluated that they could or could not perform their own stoma care under the supervision of the researcher. However, the status of individuals in the control group for maintaining stoma care is based on their own statements.

Ankara University

Student of master's degree

Gland and Hormone Related Diseases

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Rare Diseases

Pancreatic Neoplasms

Crohn Disease

Colitis

Colitis, Ulcerative

Ulcer

Ischemia

Congenital Abnormalities

Adenomatous Polyposis Coli

Diverticulitis

Anastomotic Leak

Intestinal Obstruction

Inflammatory Bowel Diseases

Gastroenteritis

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Diverticulum

Diverticular Diseases

Polyps

Adenomatous Polyps

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Syndrome

Neoplastic Syndromes, Hereditary

Intestinal Polyposis

Genetic Diseases, Inborn

Pancreatic Cancer

Familial Adenomatous Polyposis

MYH-associated Polyposis

Intraoperatively, ICG-NIRF imaging is used to visualize the blood supply and the rate of tissue perfusion in the area of the anastomotic site. Postoperatively, an additional ingress and egress analysis at specific regions of interest is performed.

intraoperative NIRF Imaging using the fluorescence agent ICG (indocyanine-green) before and after anastomosis formation, postoperative analysis of ingress and egress for specific regions of interest

ICG-NIRF Imaging plus ingress and egress analysis

Benjamin Weixler, PD MD

Leonard Lobbes, MD

Benjamin Weixler, MD PD

In this prospective, non-randomized cohort study, real-time intraoperative visualization using near-infrared-fluorescence by indocyanine green injection (ICG-NIRF) is performed at two to three time points during procedures of upper GI, lower GI and hepatobiliary surgery with anastomosis formation in open or laparoscopic surgery. Postoperatively, a detailed software-based assessment of each recording is performed to determine the objective ICG-NIRF perfusion rate before and after anastomosis formation, which is then correlated with the 30 day postoperative clinical outcome including occurrence of anastomotic leak.

Near-infrared-fluorescence by indocyanine green (ICG-NIRF) utilises the fluorescent property of intravenously injected indocyanine green (ICG) as an intravascular indicator of tissue and bowel perfusion.

The investigators hypothesise that ICG-NIRF is a suitable, reliable and precise method of visualisation of the blood supply and bowel perfusion in the area of gastrointestinal and hepatobiliary anastomosis formation.

In this prospective, non-randomized cohort study, the respective upper GI, lower GI or hepatobiliary procedure with anastomosis is performed according to standard of care and indication for the corresponding disease including non-malignant, malignant and inflammatory conditions. The following procedures are included in the study, in open or laparoscopic surgery, according to the surgeon's choice:

Upper GI surgery:

* Esophageal resection
* Subtotal or total gastrectomy with or without jejunal pouch reconstruction
* Y-Roux-reconstruction
* Right or left colonic interposition (iso- or antiperistaltic)

Lower GI surgery:

* Jejunal or ileal segmental resection
* Ileal / Ileocoecal resection
* Colectomy with restorative ileal pouch formation and ileal-pouch-anal anastomosis
* Left or right-sided hemicolectomy
* Sigmoid resection
* Rectal resections (lower anterior resection (LAR), proctectomy with colo-anal anastomosis, abdominoperineal resection)
* Stoma closure

Hepatobiliary surgery:

- Pancreaticoduodenectomy

Written informed consent for participation and ICG-administration is obtained one day before surgery.

Intraoperatively, Indocyanine Green (ICG, VerDye, Diagnostic Green GmbH, Aschheim Germany, 25 mg vials) is dissolved in 5 mL sterile water to yield a 5 mg/mL concentration. It will then be administered intravenously at three consecutive time points as a bolus of 2 ml per time point at the most. The overall dose of ICG will amount to no more than 30mg of ICG per patient.

Real-time intraoperative visualization is performed with the SpectrumTM Fluorescence Imaging Platform (Quest Innovations, Middenmeer, The Netherlands) directly after each ICG injection assessing bowel perfusion at two different time points per anastomosis respectively: before and after anastomosis formation.

Postoperative NIRF-perfusion rate assessment Using the Quest Research SoftwareTM, the recordings before and after anastomosis formation will be analysed for their perfusion rate. This analysis will provide objective, quantitative data on the perfusion for a certain time frame which is determined by the length of the video recording. This data will be collected for statistical analysis and correlation with anastomotic leak as well as postoperative outcome.

Clinical data and follow-up Clinical data will be collected from all patients regarding anastomotic leak, bowel ischemia and necrosis as well as 30 day postoperative morbidity, mortality and length and cost of hospital stay.

Further data analysis will be performed using Microsoft Excel® and IBM SPSS®.

This is a non-randomised prospective cohort study design.

Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses

Objective Perfusion Rate Assessment of Gastrointestinal Anastomoses by Inflow and Outflow Analysis of Near-infrared Fluorescence Agents

number of patients suffering from an anastomotic leak within 30 days of operation

Clavien-Dindo for complication-level classification

Charite University, Berlin, Germany

Attending Physician, Assistant Professor

Behaviors and Mental Disorders

Quality of Life

The patient will be trained with STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION. The patient will be follow up at 2nd, 6th and 12th weeks.

The patient will be trained only skills and discharge education. The patient will be follow up at 2nd, 6th and 12th weeks.

STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION: It is consist of skills, discharge, compilation and algorithm education.

STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION

It consists of only skills and discharge education

Control

Cahide Ayik

This study is a single blind semi-experimental study.

Aim: To investigate the effect of standardized care on peristomal skin complications and quality of life in colorectal cancer patients undergoing ostomy surgery.

H1: Standard stoma care which is established evidence-based guides and complication algorithm, reduces peristomal skin complications in patients with colorectal cancer and an ostomy.

H2: Standard stoma care which is established evidence-based guides and complication algorithm, increases the quality of life in patients with colorectal cancer and an ostomy.

In order to ensure blindness in the study design, patients were not informed about which group they belonged to.

Patient with ostomy in the study group were trained in accordance with the Standard Stoma Care.

Patient with ostomy in the control group only skill and discharge training has been provided in accordance with the hospital procedure.

All patients were followed up at 2, 6, and 12 weeks. Peristomal complications were evaluated by the researcher with the Peristomal Skin Tool at the 2nd, 6th and 12th weeks. The patients were asked to fill the Stoma Quality of Life Scale in the 2nd, 6th and 12th weeks.

This two-group, single-blind, quasi-experimental study enrolled 68 patients with ostomy recruited to a university affiliated hospital.

The patients with an ostomy were blinded.

Peristomal Skin Complications and Quality of Life

The Effect of Standard-Based Care on Peristomal Skin Complications and Quality of Life in Ostomy Creation Patients With Colorectal Cancer

It has been assessed with Ostomy Skin Tool. The total score can be the lowest 0 and the highest 15.

It has been assessed with stoma Quality of Life Scale. The Scale range: 0-100. Higher scores for each item indicate that the quality of life increased.

Dokuz Eylul University

Research assistant

Rectal Neoplasms

Sigmoid Neoplasms

Colonic Neoplasms

Sigmoid Diseases

All the patients who underwent anterior resection, low anterior resection and abdominoperineal resection between march 2006 and novenmer 2010

Spouses of the patients who underwent anterior resection, low anterior resection and abdominoperineal resection between march 2006 and novenmer 2010

Medical outcomes: 36-item short form health survey (SF-36)

The SF-36 was used as a measure of health-related QoL because it is an internationally recognized global measure. It comprises 36 items that measure perceived health on eight scales (i.e., physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health) with higher scores (range 0-100) reflecting better perceived health. Additionally, two summary scores can be obtained: the physical component summary score (PCS) and the mental component summary score (MCS).

In addition, this tool has been validated in Turkish patients

Short Form - 36

The World Health Organization disability assessment schedule II (WHODAS-II)

The WHODAS-II is an instrument developed by the World Health Organization to assess behavioral limitations and restrictions regarding participation in specific activity domains experienced by an individual independent of their medical diagnosis. The conceptual frame of reference of this instrument is the International Classification of Functioning, Disability, and Health (ICF). Specifically, the instrument is a 36-item, generic, multidimensional questionnaire designed to evaluate the functioning of the individual in six activity domains (i.e., understanding and communicating, getting around, self-care, getting along with people, life activities, and participation in society). This questionnaire has been validated in Turkish patients.

WHODAS-II

cihangir Akyol

The aim of the present prospective, comparative study was to compare the quality of life (QoL) of patients after colorectal surgery to the QoL of their spouses. The study included patients who underwent curative surgery for colorectal carcinoma (n = 100; abdominoperineal excision \[n = 33\], low anterior resection \[n = 33\], left hemicolectomy \[n = 34\]) and their spouses (n = 100). The patients and spouses completed the Medical Outcome Study 36-item Short Form Survey (SF-36) and the World Health Organization Disability Assessment Schedule II (WHODAS-II) preoperatively and at postoperative months 15 to 18. The QoL of patients and that of their spouses changed following surgery for colorectal cancer.

These changes were more significant among male patients' spouses.

There is no doubt that radical colorectal surgery improves the oncological outcomes of patients with cancer. However, the literature has clearly documented that social, physical, sexual, and psychological aspects of life, as well as religious worship, are severely impaired after this treatment. A significant portion of patients suffer from alterations in their quality of life (QoL), particularly after surgery on distal rectal tumors. Patients who require a stoma or who have low anterior resection syndrome may face difficulty adapting to their new anatomy, managing the stoma, defecating, and continuing normal activities in their sociocultural environment. Patients pay an immense price following both sphincter-saving and sphincter-sacrificing surgery. Moreover, these psychological and social difficulties, as well as sexual dysfunction, may affect patients' relationships with their spouses, who are generally the primary informal caregivers for patients with cancer. In addition to caring for their sick partners, the spouses also have to deal with their own anxiety, fatigue, and depression.The aim of the present prospective, comparative study was to compare the quality of life (QoL) of patients after colorectal surgery to the QoL of their spouses.

Groups

Patients and their spouses were grouped by the type of surgery they received:

abdominoperineal resection (APR), sphincter-saving resection with an anastomosis within 6 cm of the anal verge on rigid sigmoidoscopy (LAR), or anterior resection with anastomosis at or above 7 cm, including sigmoid colectomy (AR).

The study included patients who underwent curative surgery for colorectal carcinoma (n = 100; abdominoperineal excision \[n = 33\], low anterior resection \[n = 33\], left hemicolectomy \[n = 34\]) and their spouses (n = 100). The patients and spouses completed the Medical Outcome Study 36-item Short Form Survey (SF-36) and the World Health Organization Disability Assessment Schedule II (WHODAS-II) preoperatively and at postoperative months 15 to 18.

Counseling Surgical details, possible complications, and temporary or permanent stoma formation were explained preoperatively by the surgeon, and ostomy education was given by the stomatherapist. Religious education and counseling were also performed. Patients had direct access to doctors, the stomatherapist, appliance suppliers, and a religious leader (Imam) at the hospital during the study period.

Interviews Patients and spouses were interviewed at the Department of Surgery of Ibni Sina Hospital.

The coauthors of the study were trained to administer the questionnaires in a standard fashion and practiced by using the questionnaires on healthy volunteers before the study began.

Patients and spouses were interviewed in a private room by a person of the same gender. The same interviewer was used in the preoperative and postoperative period for each patient and spouse, but the interviewer was not blinded to the type of surgery that the patient had undergone. Patients were first asked to complete a demographic questionnaire designed to determine their age, gender, marital status, educational level, income level, and preoperative employment. The SF-36, WHODAS-II, and Ankara University Life Standards Questionnaire were administered together and consisted of a total of 92 items, which took approximately 35 to 45 minutes to complete. Both patients and spouses completed the SF-36, WHODAS-II, and Ankara University Life Standards Questionnaire preoperatively and at postoperative months 15 to 18.

QoL of Colorectal Cancer Patients and Spouses

Quality of Life After Colorectal Surgery: A Prospective Study of Patients Compared With Their Spouses

Medical outcomes: 36-item short form health survey (SF-36)

The SF-36 was used as a measure of health-related QoL because it is an internationally recognized global measure. It comprises 36 items that measure perceived health on eight scales (i.e., physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health) with higher scores (range 0-100) reflecting better perceived health. Additionally, two summary scores can be obtained: the physical component summary score (PCS) and the mental component summary score (MCS).

The World Health Organization disability assessment schedule II (WHODAS-II)

The WHODAS-II is an instrument developed by the World Health Organization to assess behavioral limitations and restrictions regarding participation in specific activity domains experienced by an individual independent of their medical diagnosis. The conceptual frame of reference of this instrument is the International Classification of Functioning, Disability, and Health (ICF). Specifically, the instrument is a 36-item, generic, multidimensional questionnaire designed to evaluate the functioning of the individual in six activity domains (i.e., understanding and communicating, getting around, self-care, getting along with people, life activities, and participation in society).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of Education on Self-Efficacy and Adaptation to Stoma of Individuals With Stoma	NCT05531331	Stoma Ileostomy Stoma Colostomy Self Efficacy Adjustment Colorectal Canc... Colorectal Diso...	At home educati...	18 Years -	Ankara University
Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses	NCT04709445	Bowel Obstructi... Bowel Ischemia Diverticulitis Abnormality of ... Symptomatic Dis... Stoma Ileostomy Cancer of the G... Crohn Disease Ulcerative Coli... Familial Adenom... Pancreatic Neop... Hepatobiliary N...	ICG-NIRF Imagin...	18 Years -	Charite University, Berlin, Germany
Peristomal Skin Complications and Quality of Life	NCT04375930	Colorectal Canc... Quality of Life Stoma Ileostomy Stoma Colostomy Complication	STANDARD STOMA ... Control	18 Years -	Dokuz Eylul University
QoL of Colorectal Cancer Patients and Spouses	NCT04744792	Quality of Life Stoma Ileostomy Stoma Colostomy Rectum Cancer Sigmoid Cancer	Short Form - 36 WHODAS-II	18 Years -	Ankara University
QoL of Colorectal Cancer Patients and Spouses	NCT04744792	Quality of Life Stoma Ileostomy Stoma Colostomy Rectum Cancer Sigmoid Cancer	Short Form - 36 WHODAS-II	18 Years -	Ankara University

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