Clinical trial NCT03487484: Quality of Life in Patients With Rectal Cancer Receiving Total Mesorectal Excision With or Without Stoma
Official title: Quality of Life in Patients With Rectal Cancer Receiving Neoadjuvant Chemotherapy, Total Mesorectal Excision With or Without Stoma and Adjuvant Chemotherapy: a Prospective, Single-centre Pilot-study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rectal Cancer
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-04-04
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed rectal cancer

Brief summary: The goal is to evaluate whether the renunciation of a diverting stoma in patients with adjuvant chemotherapy after low anterior resection with total mesorectal excision (TME) and neoadjuvant chemoradiotherapy leads to a better quality of life without increasing morbidity and mortality in patients with rectal cancer.

Detailed description: In most cases it is recommended that patients after low anterior resection with TME and neoadjuvant chemoradiotherapy for rectal cancer need a temporarily diverting stoma. Recent evidence suggests that this is not always necessary. The decision for or against a stoma is made by the surgeon in charge and is based on an algorithm of risk factors for anastomotic leakage. Many patients receive an adjuvant chemotherapy postoperative. This may influence the quality of life e.a. due to mucositis and urge incontinency or the stoma itself.The objective of this pilot study is to establish the basis for a randomized controlled trial. The long-term goal is to evaluate whether the renunciation of a diverting stoma in patients with adjuvant chemotherapy after low anterior resection with TME and neoadjuvant chemoradiotherapy leads to a better quality of life without increasing morbidity and mortality in patients with rectal cancer. All patients scheduled for low anterior resection of the rectum for rectal carcinoma will be invited to participate and prospectively enrolled into the study.

Eligibility criteria: Inclusion Criteria:

* age older than 18,
* low anterior resection and TME due to rectum carcinoma after standardized neoadjuvant combined chemo- and radiotherapy and receiving adjuvant postoperative chemotherapy,
* German speaking patient who is capable to fill in the questionnaire,
* signed informed consent

Exclusion Criteria:

* age younger than 18,
* preoperative stoma,
* not German speaking
* inability to fill in the questionnaire,
* no standardized chemo- and radiotherapy

Primary outcomes:
measure: Change in quality of life specific for the gastrointestinal tract
timeFrame: at Baseline and up to 12 months after surgery
Secondary outcomes:
measure: Change in quality of life
timeFrame: at Baseline and up to 12 months after surgery
measure: Change in faecal Incontinence
timeFrame: at Baseline and up to 12 months after surgery
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: St Claraspital
Study officials:
affiliation: Claraspital Basel
name: Susanne Drews, MD
role: PRINCIPAL_INVESTIGATOR
References: