Late Organ Specific Adverse Effects hiPec or pElvic eXenteration

Recruiting

• Conditions: Colorectal Cancer

• Registration Number: NCT04970316
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2021-01-25
• Study First Submitted: 2021-06-28
• Study First Submitted QC: 2021-07-09
• Study First Posted: 2021-07-21
• Status Verified: 2022-11
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-02-28
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 225

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of female urological dysfunction after PE or CRS+HIPEC for colorectal cancer	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)
Development of bowel related adverse effects after PE or CRS+HIPEC for colorectal cancer	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)
Development of male urological dysfunction after PE or CRS+HIPEC for colorectal cancer	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)
Development of pain after PE or CRS+HIPEC for colorectal cancer	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
Development of male sexual dysfunction after PE or CRS+HIPEC for colorectal cancer	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)
Development of female sexual dysfunction after PE or CRS+HIPEC for colorectal cancer	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
Development of lymphedema after PE for colorectal cancer	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
Development of stoma-related issues after PE or CRS+HIPEC for colorectal cancer	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

Name	Time	Method
Risk factors associated with developing organ specific late 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.	Univariate and multivariate regression analysis will be performed to identify potential risk factors for developing these adverse effects

Trial Locations

Locations (3)

Department of Surgery, Skånes University Hospital, Malmö; 🇸🇪 Malmö, Sweden

Department of Surgery, Karolinska University Hospital; 🇸🇪 Solna, Stockholm, Sweden

Department of Surgery, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark