Digestive System Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Fecal Incontinence

Rectal Neoplasms

Anastomotic Leak

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Postoperative Complications

Patients who undergo modified PPS surgery in order to preserve anal sphincter function under the premise of radical resection of ultralow rectal cancer.

Patients who undergo conventional sphincter-preserving surgeries.

Cheng-Le Zhuang, MD, PhD

Zhong-Chen Liu, MD, PhD

RATIONALE: Colorectal cancer is one of the most common cancers. However, approaches to minimize surgical trauma, preserve anal function, avoid abdominal stoma, and improve quality of life for patients with ultralow rectal cancers were limited. Thus, new technologies are urgently needed to improve the anal preservation rate, reduce the incidence of anastomotic leakage and improve postoperative anal function in patients with ultralow rectal cancer.

PURPOSE: This one-arm multicenter prospective cohort study aims to collect the data of patients with ultralow rectal cancer who undergo sphincter-preserving surgeries, including modified PPS and conventional surgeries, then compare the effects of different operations on clinical outcomes and to see the efficacy and safety of modified PPS surgery when compared with conventional procedures in the treatment of ultralow rectal cancer.

Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer

Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer: A Multicenter Prospective Cohort Study

The percentage of patients who get temporary defunctioning stoma to limit the consequences of anastomotic leakage.

The percentage of patients who develop anastomotic leakage

Ranging from 0 (perfect continence) to 20 (complete incontinence)

Ranging from 0 (perfect continence) to 24 (complete incontinence)

The percentage of patients who preserve the anatomical structure of the anus

The number of grade II and higher postoperative complications according to the Clavien-Dindo classification

The time between the operation date and the discharge date.

Percentage of readmitted patients within 30 days after operation

Disease-free survival is defined as the time from surgery to recurrence of tumor or death

Overall survival is defined as the time from surgery until death from any cause.

Shanghai 10th People's Hospital

Investigator assistant

Inflammatory Bowel Diseases

Diverticulitis

Diverticulitis, Colonic

Colonic Diseases

Gastroenteritis

Diverticulum

Diverticular Diseases

Diverticulosis, Colonic

Other Dietary Supplements

All Drugs and Chemicals

Chondroitin

Patients undergoing elective colorectal resection or stoma closure

Elective open or minimally invasive resection for colorectal cancer, IBD or other benign colorectal disorder, or stoma closure

Colorectal resection or stoma closure

Nanna B Hupfeld, ph.d.

Nanna B Hupfeld, MD

Claus A Bertelsen, PhD

Uffe S Løwe, PhD

This observational study aims to test proteomics, metabolomics and proteoglycans as predictors of postoperative complications after colorectal surgery and as biomarkers of colorectal cancer.

The main questions to answer are:

* can these biomarkers predict anastomotic leakages
* can these biomarkers predict recurrence after colorectal cancer
* can these biomarkers be used as diagnostic tests for colorectal cancer
* can these biomarkers be identified in the tumor

Participants will undergo elective colorectal resection or stoma closure.

The prospective cohort study will include 1,000 patients undergoing elective colorectal resections or colostomy reversal at two colorectal centers in Denmark. Repeating study blood samples will be collected on each postoperative day (POD) 1-4 or until discharge. If the participants are diagnosed with cancer, blood sampling is planned 26-35 days after the index procedure, and after one, two, and three years, a tumor biopsy will be taken from the fresh specimen in the operation theatre.

Analyses of blood plasma and tissue for oncofetal chondroitin sulfate (ofCS) proteoglycans, proteomics, and metabolomics will be performed on those repeating blood samplings to:

* To investigate whether metabolomics, proteomics, and ofCS techniques can identify new biomarkers where charges in plasma levels can predict or detect subclinical AL (primary outcome) and other major postoperative complications after colorectal surgery and prediction of 90-day and three-year mortality.
* To investigate whether the APOE genotype is associated with the risk of AL and other major postoperative complications and long-term outcomes, i.e., recurrence and mortality, after colorectal surgery.
* To examine whether metabolomics and proteomics can identify new biomarkers predicting recurrence after colorectal cancer resections.
* To identify other potential biomarkers that might enable early cancer diagnosis.
* Whether proteoglycans can be used as a diagnostic test with a high degree of separability to identify tumor markers that are usable in a clinical setting (primary outcome). Participants with colorectal cancer will be compared with a control group of participants with benign conditions.
* Whether the level of proteoglycans measured correlates to the tumor load.
* Whether the proteoglycans and proteomics detected in plasma are presented in tumor tissue from the resected specimen.
* Whether the proteoglycans detected can be used as tumor markers with a high degree or measure of separability for monitoring recurrence after colorectal cancer in a clinical setting (primary outcome).

Postoperative and follow-up data will be collected prospectively for the electronic health records.

Blood plasma Tumor tissue from participants with colorectal cancer

Colorectal Omics and ofCS Proteoglycans

Colorectal OmiCs and Oncofetal Chondroitin Sulfate-modified Proteoglycans

Results will be published by the investigators in academic journals. Sharing of generated study data will be carried out in several different ways. After acceptance from the participant and the ethics committee of the Capital Region of Denmark, individual participant data and blood plasma will be available to potential collaborators interested in colorectal disorders.

Anastomotic leakage after colorectal resection with anastomosis or stoma closure

Major postoperative complication (Clavien-Dindo score 3B or higher, and DVT and pulmonary embolism) after colorectal resection with anastomosis or stoma closure

Postoperative mortality after colorectal resection with anastomosis or stoma closure

Recurrence after radical resection, diagnosed by imaging modalities or tissue biopsy

Identifying omics and chondroitin sulfate-modified proteoglycans that can be used i a clinical setting to identify colorectal cancer patients

Does presence of tumor markers in blood plasma correlate with the same tumor makers in the tumor tissue

Viborg Regional Hospital

Claus Anders Bertelsen, PhD, MD

Clinical research professor, consultant colorectal surgeon

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

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

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
Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer	NCT05245565	Rectum Cancer Stoma Colostomy Faecal Incontin... Leakage, Anasto...		18 Years -	Shanghai 10th People's Hospital
Colorectal Omics and ofCS Proteoglycans	NCT06287671	Colorectal Canc... Diverticulitis,... Inflammatory Bo... Stoma Colostomy	Colorectal rese...	18 Years -	Nordsjaellands Hospital
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
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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