Late Organ Specific Adverse Effects hiPec or pElvic eXenteration

NCT04970316 | Unknown

• 1 other identifier: LOSAPEX
• Study Type: observational
• Target: 225
• Locations: 2 countries
• Sites: 3

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.

Conditions

Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (10)

• 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)

  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.

Secondary Outcomes (1)

• 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.

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Karolinska University Hospital: collaborator
• Skane University Hospital: collaborator

Study Sites (3)

Department of Surgery, Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Department of Surgery, Karolinska University Hospital

Solna, Stockholm County, 17164, Sweden

NOT YET RECRUITING

Department of Surgery, Skånes University Hospital, Malmö

Malmo, 21428, Sweden

NOT YET RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Intestinal Diseases; Sexual Dysfunction, Physiological; Pain; Lymphedema

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Rectal Diseases; Genital Diseases; Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Rogini Balachandran, MD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rogini Balachandran, MD

CONTACT

+4542400620; rogbal@rm.dk

Lene H Iversen, Professor

CONTACT

d268143@dadlnet.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 21, 2021
• Study Start: January 25, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: February 28, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); SE (2)