Late Organ Specific Adverse Effects hiPec or pElvic eXenteration

Colorectal Cancer Clinical Trial

— LOSAPEX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04970316
• Other study ID #: LOSAPEX
• Status: Recruiting
• Start date: January 25, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: November 2022
• Source: University of Aarhus
• Contact: Rogini Balachandran, MD
• Phone: +4542400620
• Email: rogbal[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Denmark	Department of Surgery, Aarhus University Hospital	Aarhus
Sweden	Department of Surgery, Skånes University Hospital, Malmö	Malmö
Sweden	Department of Surgery, Karolinska University Hospital	Solna	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Karolinska University Hospital, Skane University Hospital

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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
Primary	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	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.