Late Organ Specific Adverse Effects hiPec or pElvic eXenteration

Study Overview
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Brief Summary
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The purpose of this study is to describe type and extent of organ specific late adverse effects in patients undergoing surgery for colorectal cancer with peritoneal metastases and after surgery for colorectal cancer with involvement of the urinary bladder.

Detailed Description
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After being informed about the study all patients giving written informed consent will be distributed a questionnaire asking questions on bowel function, urinary function, pain, sexual function and lymphedema. All these aspects will be investigated using validated questionnaires.

Official Title
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Organ Specific Late Adverse Effects, in Colorectal Cancer Patients Following Surgery With Either HIPEC or Pelvic Exenteration

Conditions
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Colorectal Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have undergone intended curative CRS+HIPEC for peritoneal metastases originated from colorectal cancer (HIPEC cohort) according to national Danish guidelines Patients who have undergone intended curative total or anterior pelvic exenteration (PE cohort) for advanced or recurrent colorectal cancer according to national Danish guidelines Exclusion Criteria: Patients under 18 years Patients not speaking Danish or Swedish, respectively, in Denmark and Sweden Patients unable to give informed consent Patients undergoing CRS+HIPEC or PE for cancers others than CRC Terminally ill patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIPEC cohort<br>Patients undergoing cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for colorectal cancer with peritoneal metastases | |
| PE cohort<br>Patients undergoing pelvic exenteration (PE) for colorectal cancer with involvement of the urinary bladder | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of bowel related adverse effects after PE or CRS+HIPEC for colorectal cancer | Descriptive analysis will be done using following questionnaires: Skt. Marks incontinence score | PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery. | 
| Development of bowel related adverse effects after PE or CRS+HIPEC for colorectal cancer | Descriptive analysis will be done using following questionnaires: Wexner incontinence score | PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery. | 
| Development of bowel related adverse effects after PE or CRS+HIPEC for colorectal cancer | Descriptive analysis will be done using following questionnaires: LARS score (low anterior resection syndrome) | PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery. | 
| Development of male urological dysfunction after PE or CRS+HIPEC for colorectal cancer | Descriptive analysis will be done using following questionaires: ICIQ-MLUTS (ICIQ male lower urinary tract symptoms) | PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery. | 
| Development of female urological dysfunction after PE or CRS+HIPEC for colorectal cancer | Descriptive analysis will be done using following questionaires: ICIQ-FLUTS (ICIQ female lower urinary tract symptoms) | PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery. | 
| Development of male sexual dysfunction after PE or CRS+HIPEC for colorectal cancer | Descriptive analysis will be done using following questionaires: IIEF-5 (international index of erectile dysfunction) | PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery. | 
| Development of female sexual dysfunction after PE or CRS+HIPEC for colorectal cancer | Descriptive analysis will be done using following questionaires: Rectal cancer female sexuality score | PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery. | 
| Development of pain after PE or CRS+HIPEC for colorectal cancer | Descriptive analysis will be done using following questionaire: rectal cancer pain score | PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery. | 
| Development of lymphedema after PE for colorectal cancer | Descriptive analysis will be done using following questionaire: Questions regarding lymphedema from EORTC vulva cancer questionnaire | PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery | 
| Development of stoma-related issues after PE or CRS+HIPEC for colorectal cancer | Descriptive analysis will be done using following questionaire: Colostomy impact score | PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors associated with developing organ specific late adverse effects | Univariate and multivariate regression analysis will be performed to identify potential risk factors for developing these adverse effects | PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects3, 6, 12, 18, 24, 36, 48 and 60 months after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cytoreductive surgery, hyperthermic intraperitoneal chemotherapy, pelvic exenteration, adverse effects, bowel dysfunction, urinary dysfunction, sexual dysfunction, pain, lymphedema