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.
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.
Study Type
OBSERVATIONAL
Enrollment
225
Department of Surgery, Aarhus University Hospital
Aarhus, Denmark
RECRUITINGDepartment of Surgery, Karolinska University Hospital
Solna, Stockholm County, Sweden
NOT_YET_RECRUITINGDepartment of Surgery, Skånes University Hospital, Malmö
Malmo, Sweden
NOT_YET_RECRUITINGDevelopment 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
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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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
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
Time frame: 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.