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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
| Skane University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIPEC cohort | Patients undergoing cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for colorectal cancer with peritoneal metastases | ||
| PE cohort | Patients undergoing pelvic exenteration (PE) for colorectal cancer with involvement of the urinary bladder |
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| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The investigators will prospectively include patients who have undergone surgery at Aarhus University Hospital, Karolinska University Hospital, Stockholm, and Skåne University Hospital, Malmö. Inclusion in Denmark will start February 2021 and in Sweden Summer 2021. Inclusion period is 15 months.
The HIPEC cohort will be established as a cross-sectional study. For newly operated patients, inclusion will happen shortly after surgery with prospective questionnaire follow-ups at 3, 6 and 12 months after inclusion. For patients who have undergone CRS+HIPEC more than 3 months ago, initial inclusion can take place at 6, 12, 18, 24, 36, 48 and 60 months after surgery.
Patients in the PE cohort will be included shortly after surgery with follow-up at 3 months, 6 months and 12 months after surgery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rogini Balachandran, MD | Contact | +4542400620 | rogbal@rm.dk | |
| Lene H Iversen, Professor | Contact | d268143@dadlnet.dk |
| Name | Affiliation | Role |
|---|---|---|
| Rogini Balachandran, MD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Aarhus University Hospital | Recruiting | Aarhus | 8200 | Denmark |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007410 | Intestinal Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D010146 | Pain |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| 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. |
| Department of Surgery, Karolinska University Hospital | Not yet recruiting | Solna | Stockholm County | 17164 | Sweden |
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| Department of Surgery, Skånes University Hospital, Malmö | Not yet recruiting | Malmö | 21428 | Sweden |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D012002 | Rectal Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |