Late Organ Specific Adverse Effects hiPec or pElvic eXenteration

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04970316

Acronym

LOSAPEX

Enrollment

225

Registered

2021-07-21

Start date

2021-01-25

Completion date

2023-09-01

Last updated

2023-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

cytoreductive surgery, hyperthermic intraperitoneal chemotherapy, pelvic exenteration, adverse effects, bowel dysfunction, urinary dysfunction, sexual dysfunction, pain, lymphedema

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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
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: Skt. Marks incontinence 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 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 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 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 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

Secondary

Measure	Time frame	Description
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

Countries

Denmark, Sweden

Contacts

Primary ContactRogini Balachandran, MD

rogbal@rm.dk+4542400620

Backup ContactLene H Iversen, Professor

d268143@dadlnet.dk

Outcome results