Determining Early Development of Faecal Incontinence and Anorectal Muscle Function After Surgery for Rectal Cancer.

NCT03257332 | Withdrawn DMC

• 1 other identifier: EDFI-Cohort
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

Background: Patients treated for rectal cancer are in high risk of developing poor quality of life and faecal incontinence. Faecal incontinence has a negative impact on quality of life. However, there is limited knowledge on how to prevent it. Known exposures are ; age at surgery, gender, tumor height, pre-operative radiotherapy, surgical technique and temporary stoma. In order to evaluate the underlying mechanisms of faecal incontinence, it is central to evaluate the anorectal muscle function for sensory and motor impairment. Exposures representing different constructs in the biopsychosocial model are likewise likely to be associated with quality of life and faecal incontinence. These exposures include sexual dysfunction, urinary incontinence, fatique, physical inactivity and finding meaning in life. There are to our knowledge, no records on these relationships from prior to surgery to 2 years after. These biopsychosocial exposures are central to include when developing strategies that can prevent poor quality of life and faecal incontinence for patients treated for rectal cancer. Purpose: The primary purpose of the EDFI-Cohort study is to determine how several variables (surgical technique, anorectal muscle function, faecal incontinence, urinary incontinence, sexual dysfunction, fatigue, physical activity and finding meaning in life) develop over time and predicts quality of life. Secondary how it predicts LARS-score in patients with rectal cancer from prior to surgery to 2 years after primary treatment. Methods: We will include subjects diagnosed with rectal cancer and have received curative surgery (low anterior resection) with/without adjuvant (radiation/chemo) therapy. The cohort aim to recruit all eligible patients in a one year period. We estimate to recruit 70 patients. Self-reported outcomes will be collected with a series of validated questionnaires that subjects will be asked to complete 6 times during the two year study at 3, 6, 12, 26 78 and 104 weeks. Outcomes include: Quality of life using (EORTC QLQ-C30) (primary outcome), (CR29) and (FA12), bowel related quality of life (LARS-score) (secondary outcome), faecal incontinence (Vaizey score), urinary incontinence (ICIQ-UI), (MLUTS/FLUTS) and (MLUTSsex/FLUTSsex), physical activity level from Danish National Health Profile and finding meaning in life (SOME). Objective measures will be collected at 6 weeks, 6 months, 12 months and 24 months and include: Anorectal manometry that measures anorectal muscle function and rectal perception, a digital examination of anorectal muscle function using the Digital Rectal Examination Scoring System (DRESS) and the six-minute walk test a measure of submaximal exercise capacity. We plan to analyze the EDFI-Cohort study as repeated measures with both simple and multiple linear regression models for the continuous data. We plan to adjust for known confounders and variables related to treatment.

Conditions

Rectum Cancer; Quality of Life; Faecal Incontinence; Low Anterior Resection Syndrome

Keywords

Rectum cancer; Low Anterior Rectal Syndrome; Anorectal muscle function

Outcome Measures

Primary Outcomes (1)

• Global health status/quality of life: EORTC QLQ-C30

  European Organisation for Research and Treatment of Cancer's generic core set on quality of life (EORTC QLQ-C30)

  104 weeks

Secondary Outcomes (1)

• Low anterior resection syndrome

  104 weeks

Other Outcomes (16)

• Urinary incontinence

  3, 6, 12, 26, 52 and 104 weeks

• Urinary incontinence - Urinary symptoms

  3, 6, 12, 26, 52 and 104 weeks

• Urinary incontinence - Sexual dysfunction

  3, 6, 12, 26, 52 and 104 weeks

Study Arms (1)

EDFI Cohort

Subjects should have received surgery for rectal cancer (low anterior resection).

Procedure: Low Anterior Resection for Rectum Cancer

Interventions

Low Anterior Resection for Rectum Cancer PROCEDURE

Subjects should have received curative surgery for rectal cancer (low anterior resection) with/with-out adjuvant (radiation/chemo) therapy.

Also known as: Total mesorectal excision, Partial mesorectal excision

EDFI Cohort

Eligibility Criteria

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

Study Population

Subjects for the EDFI-Cohort study will be recruited during 2019 and 2020 from Department of Surgery, Slagelse, and Zealand University Hospital, Køge. Subjects need to be diagnosed with rectal cancer and have received curative surgery (low anterior resection) with/without adjuvant (radiation/chemo) therapy.

You may qualify if:

• Diagnosis of rectal cancer
• Low anterior resection (e.g. not limited to total mesorectal excision (TME) or partial mesorectal excision (PME))
• Ability to communicate in Danish
• Adults (\> 18 years of age)
• American Society of Anaesthesiologists (ASA) score: I-IV.

You may not qualify if:

• ASA score of: V-VI.

Sponsors & Collaborators

• Slagelse Hospital: lead
• Zealand University Hospital: collaborator
• Association of Danish Physiotherapists: collaborator

Study Sites (2)

Zealand University Hospital

Køge, Region Sjælland, DK-4600, Denmark

Location

Slagelse Hospital

Slagelse, Region Sjælland, DK-4200, Denmark

Location

Related Publications (3)

• Emmertsen KJ, Laurberg S; Rectal Cancer Function Study Group. Impact of bowel dysfunction on quality of life after sphincter-preserving resection for rectal cancer. Br J Surg. 2013 Sep;100(10):1377-87. doi: 10.1002/bjs.9223.

  PMID: 23939851 BACKGROUND

• Lai X, Wong FK, Ching SS. Review of bowel dysfunction of rectal cancer patients during the first five years after sphincter-preserving surgery: a population in need of nursing attention. Eur J Oncol Nurs. 2013 Oct;17(5):681-92. doi: 10.1016/j.ejon.2013.06.001. Epub 2013 Jul 17.

  PMID: 23871359 BACKGROUND

• Ma B, Gao P, Song Y, Zhang C, Zhang C, Wang L, Liu H, Wang Z. Transanal total mesorectal excision (taTME) for rectal cancer: a systematic review and meta-analysis of oncological and perioperative outcomes compared with laparoscopic total mesorectal excision. BMC Cancer. 2016 Jul 4;16:380. doi: 10.1186/s12885-016-2428-5.

  PMID: 27377924 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms; Encopresis; Low Anterior Resection Syndrome

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Colonic Diseases; Postoperative Complications; Pathologic Processes

Study Officials

• Søren T Skou, PhD

  Slagelse Sygehus

  STUDY CHAIR

• Ismail Gögenur, PhD

  Zealand University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist and PhD

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 22, 2017
• Study Start: November 12, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2022
• Last Updated: December 4, 2020

Record last verified: 2020-12

Locations

DK (2)