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Late Organ Specific Adverse Effects hiPec or pElvic eXenteration (LOSAPEX)

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ClinicalTrials.gov Identifier: NCT04970316
Recruitment Status : Recruiting
First Posted : July 21, 2021
Last Update Posted : July 21, 2021
Sponsor:
Collaborators:
Karolinska University Hospital
Skane University Hospital
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
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.

Condition or disease
Colorectal Cancer

Detailed Description:
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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Study Type : Observational
Estimated Enrollment : 225 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Organ Specific Late Adverse Effects, in Colorectal Cancer Patients Following Surgery With Either HIPEC or Pelvic Exenteration
Actual Study Start Date : January 25, 2021
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022

Group/Cohort
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



Primary Outcome Measures :
  1. Development of bowel related adverse effects after PE or CRS+HIPEC for colorectal cancer [ 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. ]
    Descriptive analysis will be done using following questionnaires: Skt. Marks incontinence score

  2. Development of bowel related adverse effects after PE or CRS+HIPEC for colorectal cancer [ 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. ]
    Descriptive analysis will be done using following questionnaires: Wexner incontinence score

  3. Development of bowel related adverse effects after PE or CRS+HIPEC for colorectal cancer [ 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. ]
    Descriptive analysis will be done using following questionnaires: LARS score (low anterior resection syndrome)

  4. Development of male urological dysfunction after PE or CRS+HIPEC for colorectal cancer [ 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. ]
    Descriptive analysis will be done using following questionaires: ICIQ-MLUTS (ICIQ male lower urinary tract symptoms)

  5. Development of female urological dysfunction after PE or CRS+HIPEC for colorectal cancer [ 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. ]
    Descriptive analysis will be done using following questionaires: ICIQ-FLUTS (ICIQ female lower urinary tract symptoms)

  6. Development of male sexual dysfunction after PE or CRS+HIPEC for colorectal cancer [ 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. ]
    Descriptive analysis will be done using following questionaires: IIEF-5 (international index of erectile dysfunction)

  7. Development of female sexual dysfunction after PE or CRS+HIPEC for colorectal cancer [ 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. ]
    Descriptive analysis will be done using following questionaires: Rectal cancer female sexuality score

  8. Development of pain after PE or CRS+HIPEC for colorectal cancer [ 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. ]
    Descriptive analysis will be done using following questionaire: rectal cancer pain score

  9. Development of lymphedema after PE for colorectal cancer [ Time Frame: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery ]
    Descriptive analysis will be done using following questionaire: Questions regarding lymphedema from EORTC vulva cancer questionnaire

  10. Development of stoma-related issues after PE or CRS+HIPEC for colorectal cancer [ 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. ]
    Descriptive analysis will be done using following questionaire: Colostomy impact score


Secondary Outcome Measures :
  1. Risk factors associated with developing organ specific late 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. ]
    Univariate and multivariate regression analysis will be performed to identify potential risk factors for developing these adverse effects



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04970316


Contacts
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Contact: Rogini Balachandran, MD +4542400620 rogbal@rm.dk
Contact: Lene H Iversen, Professor d268143@dadlnet.dk

Locations
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Denmark
Department of Surgery, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8200
Contact: Rogini Balachandran, MD    +4542400620    rogbal@rm.dk   
Sweden
Department of Surgery, Karolinska University Hospital Not yet recruiting
Solna, Stockholm, Sweden, 17164
Contact: Per Nilssons, Ass. Professor         
Department of Surgery, Skånes University Hospital, Malmö Not yet recruiting
Malmö, Sweden, 21428
Contact: Marie-Louise Lydrup, Ass. Professor         
Sponsors and Collaborators
University of Aarhus
Karolinska University Hospital
Skane University Hospital
Investigators
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Principal Investigator: Rogini Balachandran, MD Aarhus University Hospital
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04970316    
Other Study ID Numbers: LOSAPEX
First Posted: July 21, 2021    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
cytoreductive surgery
hyperthermic intraperitoneal chemotherapy
pelvic exenteration
adverse effects
bowel dysfunction
urinary dysfunction
sexual dysfunction
pain
lymphedema
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases