Neoplasms

Digestive System Diseases

All Conditions

Behaviors and Mental Disorders

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

Patients with a permanent colostomy after curative surgery for rectal cancer

All patients are asked to answer a panel of questionnaires to test validity and reliability of the Colostomy Impact Score.

Questionnaires on HRQoL and sociodemography

Helle Ø Kristensen, MD

The formation of a colostomy following surgery for rectal cancer changes body image, challenges patient practical skills and threatens quality of life. As the oncological results have improved over the last decades the number of survivors from rectal cancer who have to adjust to a cancer free life in their own homes is increasing. To enable the identification of the patients with stoma-related reduced health-related Quality of life (HRQoL) in a quick and reliable way we recently developed the Colostomy Impact Score (CI-score) comprising 7 items of stoma related factors with significant impact on HRQoL. The purpose of the present project is to perform an international validation of the CI-score and to demonstrate its applicability.

The construct validity of the CI-score will be studied internationally on crosssectional cohorts of patients with permanent colostomy after abdominoperineal excision (APE) or Hartmann's procedure in Denmark, Sweden, Spain, the Netherlands, United Kingdom, Turkey, Brazil, Egypt, Russia, Lithuania, Israel, Portugal, South Africa, Australia and China. This will be done by testing the CI-score against five anchor questions stoma impact on HRQoL, the 5 Level version og the EuroQol measuer (EQ-5D-5L) and version 3.0 of the Quality of Life Questionnaire from the European Organisation for Research and Treatment of Cancer (EORTC QLQ C30 questionnaire v3.0).

The impact of the challenges related to having a stoma may vary with different demographic, socioeconomic and cultural factors. Supplementary data on stoma care, demographics and socioeconomic status will be gathered to study the impact of patient-related factors and cultural differences on HRQoL in rectal cancer survivors with an ostomy.

This retrospective cohort study has three main aims: 1) To identify demographic and socioeconomic factors influencing stoma impact and HRQoL, 2) To asses reliability and to validate the translated and cross-cultural adapted CI score internationally in multiple different centres, across a variety of patient groups and across cultural, religious, socioeconomic and physical borders and 3) To investigate if differences in everyday stoma care and -costs across countries and cultures affect CI or HRQoL.

International validation will be conducted as a retrospective cohort study on patients with a permanent colostomy after curative intended surgery more than 12 months prior to inclusion. Local health care professionals will identify includable patients and register relevant clinical information on each patient from the hospital chart. Most centres will include patients from national or regional databases, some will however include conveniently if a database is not available. Our international collaborators will be responsible for sending out and collecting the questionnaires and returning the completed questionnaires to the undersigned. In countries with sufficient internet accessibility and -infrastructure the data collection will be web based i.e. patients are sent a link to the redcap-database for them to enter their answers directly. Some centres will employ paper versions of the questionnaires. In areas with substantial number of illiterates investigator led interviews can be performed.

As the CI-score is a construct based on a formative model, statistical analysis based on the Classical Test Theory(CCT) and Item Response Theory (IRT) cannot be applied. However, the following aspects of validity and reliability from the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) checklist15-17 can and will be evaluated:

Content validity: Comprehensiveness and relevance of the questions in the CI-score have been ensured with the way of the development of the CI-score with the starting point in a Basic Stoma Questionnaire developed by an expert group supplemented by patients ensuring that all possible factors affecting stoma function/impact was included before regression analysis lead to the seven weighed questions1. After translation and cross-cultural adaptation face-validity of each translated CI-score will be assessed again by the collaborators before inclusion of patients.

Construct validity: This will be tested with hypothesis-testing. Hypotheses regarding mean differences and expected correlations between scores of instruments are formulated a priori. Hypotheses on how the CI-score and HRQoL are related to other factors are formulated a priori. For convergent validation the CI-score will be tested against 5 anchor questions (not validated) and the EORTC QLQ C30+ the colorectal specific CR29 (validated). Cross-cultural validity: See translation section.

Reliability: For a randomly selected subgroup in each country the CI-score and anchor question will be administered twice with an interval of approximately 2 weeks. The two administrations will be independent and both the setting when answering and the forms of administration will be similar for the individual patient. For ensuring stable patients an extra question on recent changes in stoma function will be added to the retest.

Translation of the CI-score will be managed by the lead institution with few exceptions (Turkey, Russia, Israel) and will follow the translation procedure recommended by the World Health Organization. All translations are produced by a forward-backward procedure. The latter procedure is performed to ensure, that the original meaning of the concepts is derived.

The original Danish version of the CI-score has already undergone a professional translation to English. A professional translation agency will perform the translation of the English version to languages in the included countries. All questionnaires/Case Report Forms (CRF) to be filled in by patients will undergo the same translation procedure as above.

A master version of the questionnaires will be collected into a booklet. On this basis, a RedCap database will be constructed to allow for direct electronic data entry by patients. Patient not able to access the web-based system, will fill in a paper version of the booklet. According to variation between populations in respect to practically illiterate's investigator lead data collection will be allowed. However, this should be agreed by the local investigation and the steering group in the planning of the data collection and included as individual amendment to the final protocol.

Data analysis:

Construct validity: Convergent validity will be studied by testing the CI-score on APE/Hartmann-patients against two measures of HRQoL; the anchor-questions assessing the overall stoma-impact on HRQoL, the EORTC QLQ C30 questionnaire version 3.0 and the EORTC QLQ CR29. Construct validity will furthermore be assessed by hypothesis-testing assessing the direction and magnitude of the expected correlations. Test-retest reliability will be studied on a subgroup in all included countries. Also, we will include questions on background demographics, socioeconomic status, everyday stoma care and -costs thereby enabling investigation of the practical and economic aspect of living with a stoma varying from country to country.

Statistical analysis:

Statistical analysis will be performed separately for each country. The correlations between total CI-score, anchor questions and the EORTC questionnaire results will be calculated for all participating patients according to the guidelines for the scores. For each CI-score group (minor CI/major CI) the mean EORTC QLQ C30-score will be calculated, testing the overall difference of impact on HRQoL between the CI-score groups.

Using the anchor-questions, the patients are divided into two HRQoL groups of those reporting no/minor or some/major impact on HRQoL. Relationship between CI-score and HRQoL group will be illustrated in box-plot for each country, where we expect statistically significant differences in median CI-score between the two HRQoL groups. Differences will be tested by Mann-Whitney U test. A contingency 2 by 2 table will be used to assess the degree of agreement between the two CI-score groups and the two HRQoL groups. Based on this, the sensitivity for the score will be calculated for each country. The added questions about irrigation and stoma-bag change frequency will be compared country-wise. Univariate regression analysis, descriptive analysis and estimation of impact on HRQoL will be performed. Test-retest reliability will be evaluated using Intraclass Correlation Coefficient and Cohens' Kappa.

Surviving Rectal Cancer at the Cost of a Colostomy International Validation of the Colostomy Impact Score

Description of sensitivity, specificity and construct validity (hypothesis testing) of the Colostomy Impact Score.

Comparing HRQoL between sexes, age groups and different socioeconomic and religious groups and by country.

Eloy Espin, Department of Surgery, Universidad Autonoma de Barcelona

Kelly Buzatti, Federal University of Minas Gerais

Dong Pang, Peking University School of Nursing

Mansoura University

Edgar Furnee, University Medical Center, Groningen

Annika Sjövall, Karolinska Institute, Stockholm

Tomas Poskus, Faculty of Medicine, Vilnius University

Sheba Medical Center

Andrea Warwick, Redcliffe and QEII Jubilee Hospitals

Nuno Rama,Centro Hospitalar Leiria Pombal

Aarhus University Hospital

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pharmaceutical Solutions

All Drugs and Chemicals

Anti-Infective Agents

Herbal and Botanical

Anti-Bacterial Agents

Antibiotics, Antitubercular

Cola

pseudocontinent perineal colostomy using shmidt technique for perineal reconstruction after abdominoperineal resection

Permanenet left iliac colostomy , the standard technique after abdominoperineal resection and primary closure of the perineal wound

The procedure is performed in 2stages: as a usual APR starting by a laparoscopic approach esnsuring a complete mesorectal excision,then a perineal approach ensuring an extended excision of the entire internal and external sphincter complex, allowing the excision of the specimen.

8to10cm of tof the colon is resected and harvested as a free graft, stripped of its meso and epiploics , then from its mucosa and placed in an antibiotic solution for 10min. This graft is wrapped snugly around the end of the colon 2-3 cm from its distal end for 1 and a half round. Absorbable 3.0 Sutures are taken to hold it in place. The end of the colon is brought out as a stoma in the perineum.

Colonic irrigations are started from the third day according to the protocol previously reported. Patients and one of their family members are daily educated and assisted while performing colonic irrigations by specialized nurses.

Perineal pseudocontinent colostomy

After a usual laparoscopic APR, the perineal wound is closed and a permanent left iliac colostomy is performed

Permanent left iliac colostomy

Aim of this study is to compare the cost-effectiveness and the quality of life in the 6 months following the surgery of a pseudo continent perineal colostomy (PCPC) and a permanent left iliac colostomy (PLIC) following an abdominoperineal resection (APR) for ultra low rectal cancer

The surgical treatment of ultra low rectal adenocarcinoma has known great changes, yet the abdominoperineal resection (APR) is still indicated in over 20% of these cases.

A permanent left abdominal stoma is the standard salvage technique.

The pseudo continent perineal colostomy (PCPC) is an alternative technique especially in low income countries where the stoma bag and stoma care is not covered by health insurances.

Furthermore, this technique allows the conservation of body image, which is frequently requested by muslim patients whenever it is possible.

The aim of this study is to compare the cost effectiveness of both techniques as well as the quality of life of patients in the 6 first months following the surgery.

Pseudo Continent Perineal Colostomy vs Permanent Left Iliac Colostomy After Abdominoperineal Resection for Ultra Low Rectal Adenocarcinoma

Pseudo Continent Perineal Colostomy vs Permanent Left Iliac Colostomy After Abdominoperineal Resection for Ultra Low Rectal Adenocarcinoma: Comparaison of Out of Pocket Costs, Hospital Bills and Quality of Life

defined by out of pocket costs during the first 6 months following the surgery in euros

defined as Out of pocket hospital bills in euros for all of the admission and the readmissions for surgical complication management

using the EORTC C30 Quality Of Life questionnaires

using the EORTC CR29 Quality Of Life questionnaires

defined by the Clavien Dindo rated from I to V at 90 post operative day.

Institut National d'Oncologie Sidi Mohammed Ben Abdellah

Moroccan Society of Surgery

professor

Ostomy self-management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations

Usual care in peri-operative and long-term settings is not standardized for ostomy patients. Usual care does not provide any formal, reproducible training for patients or their caregivers. It typically consists of an Ostomy Care Nurse who works with patients and caregivers concerning technical issues (fitting, emptying, supplies, surrounding skin care, etc.) while the new ostomate is still an inpatient

Ostomy Self management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations

Ostomy self management training

Robert Krouse, MD

The purpose of this study is to test the benefits of an educational program, the Ostomy Self-Management Training (OSMT) program, for improving patient activation (preparedness to do self-care), self-efficacy (patients' ability to do self-care), knowledge of ostomy/urostomy self-care, quality of life, mood, use of medical services, and financial burden in patients with ostomies. The study will compare patients in the intervention (training) group and patients in the usual care group.

Subjects' participation in this study is expected to last about 7 months. The PI plans to enroll up to 176 subjects at 3 hospitals (University of Pennsylvania, Yale University School of Nursing, and City of Hope in Los Angeles). All patient telehealth education will be coordinated by the University of Arizona in Tucson, Arizona.

Over one million individuals in the U.S. have ostomies. The American Cancer Society estimates 39,610 rectal cancer cases and 74,000 bladder cancer cases will be diagnosed in 2015. Of these, at least 30,000 will receive ostomies, and an additional unknown number due to gynecologic, other gastrointestinal tumors. The HRQOL impact is tremendous and greater than with many other cancer treatments. An ostomy is often a prolonged or lifelong disabling problem for cancer survivors. The adaptation period is quite variable. 18% of participants took at least one year, or never felt comfortable, in their ostomy care. Importantly, many patients cannot attend selfmanagement programs or patient groups for a myriad of reasons, including distance to travel, monetary outlays, comorbidities making travel difficult, or lack of access to transportation. In addition, a national shortage of OCNs means patients with an ostomy, whether newly placed or a long-term issue, receive little help.

It is imperative to study interventions for these cancer survivors aimed to limit family financial burdens, decrease medical care use, and improve well-being. This study has the potential to improve health care outcomes for cancer survivors with ostomies by enhancing their knowledge of and self-efficacy with ostomy care. This will be accomplished by improving the ability to communicate an established educational curriculum developed based on patient needs and desires and refined via a pilot study.

Ostomy Telehealth For Cancer Survivors

Our Program Project team supports and promotes the sharing of resources as promoted by PCORI. Progress in medical research in general, and patient-reported outcome cancer research in particular, benefits from enhanced collaboration and sharing of data between productive, collaborative investigators. Based on this concept, our policy is to make the data collected as part of this proposal available to outside investigators based on the following guidelines.

* Our final research data will be shared with interested colleagues through peer-reviewed publications and presentations at scientific meetings.
* Any sharing of data with outside investigators must preserve the anonymity of the subjects per HIPAA guidelines.
* Collaboration with key personnel identified in the proposal is encouraged, but not strictly required.

The patient activation measure (PAM) is a 100-point, quantifiable scale determining patient engagement in healthcare. PAM uses a uni-dimensional, probabilistic Guttman-like scale that reflects a developmental model of activation involving four stages (see below). 0 indicates lower activation (worse) whereas 100 indicates higher activation (better)

(1) believing the patient role is important, (2) having the confidence and knowledge necessary to take action, (3) actually taking action to maintain and improve one's health, and (4) staying the course even under stress.

Modified from Lorig and colleagues' Self-Efficacy to Perform Self-management Behaviors Scale, an outcome measure for Chronic Disease Management Interventions, this scale represents 8 domains with reported Cronbach's alpha for original scales: physical activity, information seeking,support, communication with HC providers, ostomy management , social and recreational, symptom management, and depression.

Range 1 to 10, where higher is better outcome

City of Hope Medical Center

Yale University

University of Arizona

University of Pennsylvania

The intervention arm integrates goal setting and problem-solving approaches to enhance buy-in and encourage ability to carry out ostomy self-care. The curriculum was delivered via four group sessions by trained ostomy certified nurses and peer/experienced ostomates. An additional session was offered to support persons to address their needs related to ostomy care. Telehealth real-time videoconferencing was used to enhance program delivery to participants, usually in their homes, in three different geographic areas across two time zones. Self management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations

Ostomy Self Management Training

Patients in the usual care group receive regular ostomy care in a clinic or via email or phone, as well as a list of local and regional resources. These study subject were expected only to complete study surveys.

Usual Care

Comparing OSMT group to UC group The intervention arm integrates goal setting and problem-solving approaches to enhance buy-in and encourage ability to carry out ostomy self-care. The curriculum was delivered via four group sessions by trained ostomy certified nurses and peer/experienced ostomates. An additional session was offered to support persons to address their needs related to ostomy care. Telehealth real-time videoconferencing was used to enhance program delivery to participants, usually in their homes, in three different geographic areas across two time zones.

Ostomy Self management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations

Comparing OSMT group to UC group

Subjects were provided with physician and Wound ostomy nurses contacts and written information about an ostomy care. These study subject were expected only to complete study surveys.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Research projects to be performed will include oversight of all aspects of the project including training and overseeing staff, participating in weekly conference calls, and coordinating data collection.The PIs will participate in data interpretation and dissemination of project findings.

Region of Enrollment

Study sites are three diverse geographic areas to ensure participation of diverse populations. Each of our participating institutions has a large catchment area which includes rural and inner-city populations. These are patient populations that are often under served as there is difficulty in participating in support groups or

Randomization methods led to equal numbers of males and females,but did not achieve balance.Several intervention subjects completed surveys without attending sessions. Few participants dropped out of the study due to a technology related concern.

Dr. Robert Krouse

Baseline

Post session

6 months follow up

The intervention arm integrates goal setting and problem-solving approaches to enhance buy-in and encourage ability to carry out ostomy self-care. The curriculum was delivered via four group sessions by trained ostomy certified nurses and peer/experienced ostomates. An additional session was offered to support persons to address their needs related to ostomy care. Telehealth real-time videoconferencing was used to enhance program delivery to participants, usually in their homes, in three different geographic areas across two time zones.

Ostomy Self management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations

Intent to treat participants who provided baseline and at least one followup measurement

Patient Activation Measure (PAM), a 100 Point Scale Determining Patient Engagement in Healthcare.

Self-Efficacy to Perform Ostomy Self-Management Behaviors

Overall Study

Colonic Neoplasms

Colonic Diseases

Surgery technique in the formation of permanent end colostomy

Surgery procedure: a non-mesh prophylactic surgical technique to prevent PH

Extra-peritoneal

Gregory Taylor

A randomised controlled feasibility study to compare two surgery techniques in the formation of a permanent end colostomy; the trans-peritoneal(TP) technique - currently, the most commonly used technique and the investigational extra-peritoneal(EP) technique, which has been reported in small studies to reduce the risk of parastomal hernia . This feasibility study will primarily aim to determine the feasibility viability of progression to a full multi-centre trial and test study design acceptability for participants. Participants will be asked to consent to be randomised to either the TP or EP procedure during surgery. Following surgery, participants will be followed up to a maximum of 12 months and asked to complete quality of life questionnaires (EQ5D and Colostomy Impact Score). Participant data will also be accessed by research teams at site to collect data on stoma appliance use and complications.

This feasibility study is a multi-centre, single (patient) blinded, randomised controlled trial (RCT). Co-ordination and trial management will be led from Swansea Trials Unit (STU).

The study will take place across 3 sites: Swansea Bay University Health Board (SBUHB); Aneurin Bevan University Health Board and Cardiff and Vale University Health Board. Surgeons at all three sites have experience with both interventional extra-peritoneal surgical technique and the most commonly used transperitoneal technique.

The investigators aim to recruit 60 participants over 12 months. Local recruitment will be co-ordinated by PIs and research teams. Recruitment is aimed to be equally distributed across all sites. Participants will be equally randomised by arm in each of the three sites: to receive the EP colostomy formation (Intervention) or the standard transperitoneal (TP) technique. Participants will remain blinded as to their treatment until the close of the study.

Data collection will be performed by the clinical and research teams, with support from PIs. Data will be stored centrally in REDCap (Research Electronic Data Capture) software.

The investigators will explore whether it is possible to establish a research infrastructure in which data can be collected and co-ordinated across sites and for patients to be followed up effectively. The investigators will also look to demonstrate standardisation of the operative technique for EP stoma formation and to determine which outcome measures a future trial should explore. This feasibility trial be evaluated against ACCEPT progression criteria.

ExPECT: Extraperitoneal End Colostomy Trial

ExPECT: Extraperitoneal End Colostomy Trial - Feasibility Phase

No current plan to share IPD but will discuss with study team if and/or when the request arises.

% follow up data collected for 80% of participants

number of surgeons at sites willing to be involved in the trial

number of patients recruited at each site to be at least 10

ability to successfully train surgeons taking part

80% compliance with the correct technique required

collection of colostomy impact score, EQ-5D and rate of parastomal hernia

QoL data to be 80% or more of that in the standard care group

Swansea University

Swansea Bay University Health Board

Symptoms and General Pathology

Wounds and Injuries

Rare Diseases

Hernia

Surgical Wound

Pathological Conditions, Anatomical

Oculocerebral Syndrome With Hypopigmentation

Amino Acids

Proline

the classic cruciate incision in the colostomy construction

longitudinal incision with two proline sutures

longitudinal incision in the construction of an end colostomy

construction of an end colostomy

Garazi Elorza

Garazi Elorza, MD

Jose Maria Enriquez-Navascues, PhD

TITLE:

"Incidence of parastomal hernia: Randomized clinical trial comparing the longitudinal fascial incision (" Hepworth hitch ") vs. cruciate incision in the exteriorization of a end colostomy ".

DESIGN:

Randomized, open and parallel clinical trial so patients will be assigned to the cruciate incision group or longitudinal incision with a 1: 1 allocation ratio.

POPULATION:

Patients undergoing colorectal cancer surgery a definitive end colostomy.

OBJECTIVES:

The main objective is to compare the parastomal hernia rate diagnosed by imaging at 2 years after surgery.

Secondary objectives are:

1. Clinically relevant parastomal hernia rate by physical examination 2 years after surgery.
2. Incidence of postoperative complications related to the stoma (dehiscence, retraction, stenosis, necrosis, surgical revision, prolapse and special needs of care of the stoma in the immediate or late postoperative period); 3) Incidence of postoperative complications assessed according to the Comprehensive Complication Index (CCI) scale.

4) Ease / difficulty in the management of stomatherapy devices by patients using VAS (Visual Analogue Scale).

DESCRIPTION OF THE INTERVENTION:

An end colostomy without placement of a prophylactic mesh will be performed in all patients. In the group 1A, a longitudinal incision will be made in the anterior rectus fascia and in the posterior fascia, with two Prolene sutures at the ends of the incision of the anterior aponeurosis. In patients of group 1B, a cruciate incision will be made in the anterior rectus fascia, as well as in the posterior fascia.

DURATION OF THE STUDY:

The expected duration of the study is 3 years.

PATIENT FOLLOW UP TIME:

The planned follow-up time is 2 years.

EXPECTED RECRUITMENT TIME:

12 months.

Parastomal hernia is one of the major complications after definitive terminal colostomy in patients with colorectal cancer, which is clinically relevant in up to 50% of the cases but can reach 78% of cases when radiologically identified. Although the majority of cases are asymptomatic, 26-30% of patients will require surgical intervention of the parastomal hernia for their symptoms, obstruction, incarceration, prolapse, leaks or aesthetic reasons.

Traditionally, the colostomy is made with a circular skin incision, dissection of the subcutaneous fat to the fascia and an incision of approximately 3 cm longitudinal and approximately 2 cm transversely. The anterior rectus muscle is loosened in the direction of the fibers and another cross incision is made in the posterior fascia to subsequently externalize the colon. The colostomy is fixed to the skin using mucocutaneous stitches of absorbable suture.

The hypothesis is that the longitudinal incision technique supplemented with Prolene stitches at the upper and lower ends of the incision acts as a "barrier" for the expansion of the hernia.

We designed a clinical trial to study the prevention of parastomal hernia with a simple modification such as making a vertical incision associated with four prolene stitches at the ends of incision, with minimal morbidity and an easy technique. The objective of the study is to analyze the postoperative parastomal hernia rate compared to the conventional technique (crossed incision).

JUSTIFICATION:

The longitudinal incision with prolene stitches at the ends of the incision is an easy and reproducible technique, with minimal morbidity. This technique is based on the theory that the hernia is a dilation of the hole that the surgeon has created. A vertical incision with two non-absorbable stitches at the ends would prevent the hole from dilating, since these act as a "barrier". This technique is related to a lower rate of parastomal hernias.

The objective of the study is to analyze if there are differences in the rate of parastomal hernias, clinically and radiologically measured without increasing postoperative morbidity.

POTENTIAL RISKS AND BENEFITS

Both techniques, the vertical incision and the crossed incision are approved techniques that are performed in a standardized way in most centers. There are no potential risks associated with the study intervention, beyond the intrinsic risks of the surgical intervention itself.

OBJECTIVES OF THE STUDY:

1. The main objective is to compare the rate of parastomal hernia diagnosed by image 2 years after surgery.
2. Secondary objectives are:

   * Clinically relevant parastomal hernia rate by physical examination 2 years after surgery.
   * Incidence of postoperative complications related to the stoma (dehiscence, retraction, stenosis, necrosis, surgical revision, prolapse and special needs for stoma care in the immediate or late postoperative period);
   * Incidence of postoperative complications assessed according to the Clavien-Dindo scale 10 and the Comprehensive Complication Index (CCI) 11.
   * Ease / difficulty for the handling of stoma therapy devices by patients using the Visual Analogue Scale (VAS)

   Clavien-Dindo Scale: The therapy used to correct a specific complication is the basis of this classification in order to rank a complication in an objective and reproducible manner.

   Grade I: any deviation from the normal postoperative course without the need for pharmacological treatment.

   Grade II: requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.

   Grade III: requiring surgical, endoscopic or radiological intervention. Grade IV: life-threatening complication requiring ICU management. Grade V: death of the patient.

   Comprehensive complication index (CCI): is based on the complication grading by Clavien-Dindo Classification and implements every occurred complication after an intervention. The overall morbidity is reflected on a scale from 0 (no complication) to 100 (death).

   Visual analogue scales (VAS) is psychometric measuring instrument designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control, measuring from 0 (unhappy) 10 (very happy).

   STUDY OUTCOME MEASURES

   The following variables will be collected:

   • Demographic: sex, date of birth, weight, height, BMI, abdominal circumference, medical history (COPD, DM, respiratory failure, etc.), surgical history, date of tumor diagnosis, neoadjuvant treatment.
   * Preoperative evaluation: incisional hernia or previous hernias, previous abdominal surgeries, previous stoma.
   * Surgical treatment: date of surgical intervention, antibiotic prophylaxis, type of surgical approach, surgical team, mechanical bowel preparation, type of surgery (Hartmann intervention or abdominoperineal resection), descent of the splenic angle, stoma measurements, need for transfusion, duration of the intervention, bleeding, intraoperative complications.
   * Postoperative evolution: postoperative complications, date of diagnosis, reoperation, colostomy stenosis, colostomy prolapse, transfusion, hospital stay, postoperative mortality, and readmission.

   Evolution and follow-up: radiological or clinical parastomal hernia at one month, 12 months and 24 months.

   STUDY DESIGN

   • Randomized clinical trial, with a ratio of 1: 1, controlled, single-blind (the patient) of patients undergoing colorectal cancer who undergo a terminal colostomy without mesh.

   • The study population is patients hospitalized in participating centers with colorectal cancer, who underwent Hartmann's intervention, Miles' abdominoperineal amputation or Intersphincteric amputation, with definitive terminal colostomy.

   • Multicenter trial.

   • The expected recruitment period is 12 months. The follow-up time of the patients in the study is 24 months.

   • The approximate duration of the study is 3 years.

   Sample size calculation:

   According to published clinical trials and systematic reviews, up to 50% of patients with a terminal colostomy will develop a parastomal hernia. The estimated risk based on the publication by Manook et al, with the longitudinal incision of the fascia and Hepworth stitches is 10%. With the confidence level to 95% and a statistical power of 80% and having an expected loss ratio of 10% in each group, the sample size should be 21 in each group.

   Randomization process:

   Patients who meet the inclusion criteria for the study will be randomized using random number generating functions with the SPSS v.25 program in the longitudinal incision group or the crossed incision group. The randomization will be 1: 1 and will be stratified by the participating centers.

   The allocation will be concealed by means of sealed opaque envelopes. The envelope will be opened in the operating room at the beginning of the surgical intervention.

   Masking process:

   The patients do not know the intervention group to which they have been assigned. The surgeons and researchers know the group to which the patient has been assigned.

   DESCRIPTION OF THE STUDY INTERVENTION
   * General considerations in all patients included in the study:
   * Lithotomy position when doing the colostomy, regardless of whether it is subsequently modified in the prone position. Surgery by laparotomy or laparoscopy, performing Hartmann's Intervention or Abdominoperineal Amputation.
   * Balanced general anesthesia, with or without epidural catheter. Avoid volume overload and promote normothermia.
   * Usual positioning of the trocars (modifiable according to the surgeon's preferences). The extraction of the piece will be performed by a Minipfannenstiel, laparotomy or perineum, not through the colostomy incision.
   * The descent of the splenic angle must be total / partial / nule at the surgeon's discretion, but it must be stated in the notebook.
   * All patients participating in the study should undergo a colostomy in an area previously marked by a stomatherapist.
   * The colostomy is preferably externalized through the rectus abdominis muscle, but the externalization of the colostomy through the external oblique muscle is not an exclusion criterion, it must be stated in the notebook.
   * In the longitudinal incision group, the incision will be made on the aponeurosis of the anterior rectum of about 3 cm in length, without making any transverse incision. Depending on the diameter of the colon, two simple stitches of a 2/0 Prolene suture will be made at each end of the incision.
   * In the group of the cross incision, a longitudinal incision will be made on the aponeurosis of the anterior rectus or external oblique, about 3 cm long and another transverse incision, about 2 cm long, 1 cm on each side.
   * The length of the incision of the fascia must be recorded in the notebook.
   * The colostomy will be fixed to the skin with absorbable stitches, at the surgeon's discretion.
   * The fast track principles approved by different participating centers will be applied.

   STUDY CALENDAR (SCHEDULE)

   Colorectal cancer patients will be visited at outpatients. If the patient meets inclusion criteria, informed consent will be obtained in Outpatient Consultations, during colostomy marking or during admission prior to surgery.

   Preoperative study period:
   * PRELIMINARY PHASE: Preparation of data collection form.
   * RECRUITMENT PHASE (12 months):

   Visit -1 Colorectal cancer patients who are going to have a terminal colostomy are visited in the outpatient clinic. If the patient meets inclusion criteria, the clinical trial will be explained and the informed consent will be signed. The stomatherapist marks the stoma site prior to surgery.

   Visit 0 It will be confirmed that the patient has signed the informed consent. It will be verified that the patient meets the inclusion criteria. Baseline data and confounding factors described in the variables will be obtained.

   In the operating room, the randomization envelope will be opened and the surgical technique will be performed.

   Visit +1 Postoperative variables will be collected: stoma status, postoperative complications, reoperations, transfusions, hospital stay, postoperative mortality, and readmission.

   • FOLLOW-UP PHASE (24 months): Obtaining the data and variables will be obtained on visits to the first month, 12th and 24th month. A clinical and radiological examination will be performed at each consultation. The patient must complete the corresponding questionnaires. BMI and abdominal circumference will be measured in control visits.

   • PUBLICATION PHASE (6 months): Preparation of the article for the publication of the results: 6 months after the process of data collection and statistical analysis finished.

   •DISTRIBUTION OF TASKS: The patients included in the study will be randomized. One of the main researchers will be responsible for the study design and analysis. The research group as a whole is responsible for preparing the publication of the results obtained.

Longitudinal Incision Versus Cruciate Incision in the Construction of an End Colostomy

Parastomal Hernia Prevention: Longitudinal Incision Versus Cruciate Incision in the Construction of an End Colostomy. LONG CROSS Trial

using VAS scale (Visual Analogue Scale). Visual analogue scales (VAS) is psychometric measuring instrument designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control, measuring from 0 (unhappy) 10 (very happy).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Surviving Rectal Cancer at the Cost of a Colostomy International Validation of the Colostomy Impact Score	NCT03516916	Rectal Neoplasm... Quality of Life Colostomy Stoma	Questionnaires ...	18 Years -	Aarhus University Hospital
Pseudo Continent Perineal Colostomy vs Permanent Left Iliac Colostomy After Abdominoperineal Resection for Ultra Low Rectal Adenocarcinoma	NCT04141566	Rectal Neoplasm... Colostomy Stoma Quality of Life	Perineal pseudo... Permanent left ...	18 Years -	Moroccan Society of Surgery
Ostomy Telehealth For Cancer Survivors	NCT02974634	Colostomy Stoma	Ostomy self man...	21 Years - 110 Years	University of Pennsylvania
Surviving Rectal Cancer at the Cost of a Colostomy International Validation of the Colostomy Impact Score	NCT03516916	Rectal Neoplasm... Quality of Life Colostomy Stoma	Questionnaires ...	18 Years -	Aarhus University Hospital
ExPECT: Extraperitoneal End Colostomy Trial	NCT05163873	Colostomy Stoma Cancer of Colon Surgery Quality of Life	Extra-peritonea...	18 Years -	Swansea Bay University Health Board
Longitudinal Incision Versus Cruciate Incision in the Construction of an End Colostomy	NCT04397783	Colorectal Neop... Parastomal Hern... Colostomy Stoma	construction of...	18 Years - 85 Years	Hospital Donostia

Spots Global Cancer Trial Database for colostomy stoma