Trial Title:
Effects of Different Treatment for Anorectal Function of Patients With Rectal Cancer
NCT ID:
NCT05671809
Condition:
Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Conditions: Keywords:
Anorectal function, Rectal cancer, NCRT, Surgery
Study type:
Observational [Patient Registry]
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
NCRT with surgery, or NCT with surgery, or surgery
Description:
The eligible patients who voluntarily sign the consent form will undergo either NCRT with
surgery, or NCT with surgery, or surgery according to treatment guidelines.
Arm group label:
NCRT with surgery
Arm group label:
NCT with surgery
Arm group label:
surgery
Summary:
Background
Neoadjuvant chemoradiotherapy (NCRT) and total mesorectal excision are standard
treatments for patients with locally advanced rectal cancer. These sphincter-saving
operations may be accompanied by a series of functional disorders. Prospective studies
dynamically evaluating the different roles of surgery and NCRT on anorectal function are
lacking.
Methods/design
The study is a prospective, observational, controlled, multicentre study. After screening
for eligibility and obtaining informed consent, a total of 402 rectal cancer patients
aged from 18 to 75 years old undergoing sphincter preservation treatments at The Sixth
Affiliated Hospital, Sun Yat-sen University and Nanfang Hospital, Southern Medical
University are included in the trial. The primary outcome measure is the average resting
pressure of anal sphincter. The secondary outcome measures are maximum anal sphincter
contraction pressure and Wexner continence score. Evaluations will be carried out at the
following stages: baseline (T1), after radiotherapy or chemotherapy (before surgery, T2),
after surgery (before closing the temporary stoma, T3), and at follow-up visits (every 3
to 6 months, T4, T5......). Follow-up for each patient will be at least 2 years.
Discussion
We expect the program to provide more information on therapeutical options and strategies
to reduce anorectal dysfunction of rectal cancer patients who have been undergone
sphincter preservation treatments.
Detailed description:
Study design and setting
The study is a prospective, observational, controlled, multicentre study of patients
diagnosed with rectal cancer. The eligible patients will be informed about the study in
detail. After providing written informed consent, these patients will undergo
sphincter-preserving therapies including either NCRT with surgery, or NCT with surgery or
surgery. All patients will receive anorectal manometry and Wexner continence score before
and after therapies and at follow-up visits.
Participants
Patients diagnosed with rectal cancer at The Sixth Affiliated Hospital, Sun Yat-sen
University and Nanfang Hospital, Southern Medical University will be assessed for
suitability for inclusion.
Inclusion criteria
18-75 years of age. Rectal cancer with pathological diagnosis. Patient will undergo
sphincter-preserving therapies. ECOG score for performance status is 0-2. Written
informed consent.
Exclusion criteria
Patients who have undergone rectal cancer surgery. Patients who have received pelvic
radiotherapy. Patients with other active malignant tumors. Recently (less than 4 weeks)
received surgery or patients with recent severe trauma.
Significant cardiac disease: congestive heart failure of New York Heart Association class
≥2; patients with recent (less than 12 months) active coronary artery disease (unstable
angina or myocardial infarction).
Recent (less than 6 months) thrombosis or embolism events, such as cerebrovascular
accident (including transient ischemic attack), pulmonary embolism and deep vein
thrombosis.
Patients with toxicity (CTCAE Grade ≥ 2) caused by previous treatment that has not
subsided.
Pregnant or lactating women.
Interventions
The eligible patients who voluntarily sign the consent form will undergo either NCRT with
surgery, or NCT with surgery, or surgery according to treatment guidelines.
Outcomes
Evaluations will take place at baseline (T1), after radiotherapy or chemotherapy (before
surgery, T2), after surgery (before closing the temporary stoma, T3), and at follow-up
visits (every 3 to 6 months, T4, T5......). Follow-up for each patient will be at least 2
years.
The primary outcome is the average resting pressure (ARP) of anal sphincter. The
secondary outcomes are maximum anal sphincter contraction pressure and Wexner continence
score. High-resolution anorectal manometry will be used to assess the average resting
pressure and maximal contraction pressure. We will use high-resolution anorectal
manometry with a 24-channel water-perfused catheter (Multiplex, Alacer, Biomedica, Sao
Paulo, Brazil), which has proven to be adequate for clinical use. This test will be
performed by a trained physician. In addition, we will use Wexner continence score to
assess fecal incontinence symptoms and their impact on the quality of life of patients
following sphincter-preserving rectal cancer surgery.
Recruitment
Patients aged 18-75 years who have been diagnosed with rectal cancer and consider
sphincter-preserving therapies are eligible for the study. The study physicians will
inform the patients about the study in detail. After obtaining informed consent, the
patient is recruited to the study.
Allocation
The study is a prospective, observational, controlled study without randomization.
Treatment decisions will be made by multidisciplinary team for eligible patients who
voluntarily sign the consent form. All patients will receive evaluation of the anorectal
function through anorectal manometry and Wexner continence score before and after
therapies and at follow-up visits.
Participant timeline
Recruitment started in December 2022 at The Sixth Affiliated Hospital, Sun Yat-sen
University and Nanfang Hospital, Southern Medical University.
Sample size
The sample size calculation was performed considering the results of a previous
case-control study with rectal cancer patients undergoing chemoradiotherapy and/or
surgery. In this study, RP was significantly lower in the chemoradiotherapy group than in
the surgery group (32.7 +/- 17 vs 45.3 +/- 18 mmHg; P =.03) at the time of ileostomy
closure. These values were introduced at PASS v11 software (NCSS, LLC. Kaysville, Utah,
USA) with a power of 80%, alpha 0.05, and an enrollment ratio of 1/1, resulting in an
estimated sample size of 122 participants in each group. Then, considering the need of
lost to follow-up, which is estimated at around 10.0% of the cases, we will require a
total of 134 patients in each group.
Data management, collection and monitoring
All protocol-required information collected during the study will be entered by the
investigator in the electronic case report forms (CRF). The investigator should complete
the CRF as soon as possible after information is collected. An explanation should be
given for all missing data. The completed CRF will be reviewed and signed by the
investigator. The main investigator will continuously monitor data. Data will be stored
in the secured network of Sun Yat-sen University and for security reasons, in an external
hard drive which will be used to back up regularly the database.
Statistical methods
For statistical analysis of the quantitative variables with normal distribution, the
mean, standard deviation (SD), median and interquartile range will be calculated. Group
comparisons will be made using t tests or Mann-Whitney U test for continuous variables.
Associations between the categorical variables will be tested with the Chi-Square-test or
the Fisher exact test, when appropriate. Paired values (before and after therapies) will
be compared for each patient using a paired t test or a Wilcoxon test. The data will be
analyzed using IBM SPSS Statistics for Windows, version 27.0 (IBM Corporation, Armonk,
NY, USA). A significance threshold of p < 0.05 will be adopted for all tests.
Research ethic approval
The study adheres to the Declaration of Helsinki on medical research protocols and
ethics. The protocol was reviewed and approved by the Human Medical Ethics Committee of
the Sixth Affiliated Hospital of Sun Yat-sen University (number 2022ZSLYEC-614).
Criteria for eligibility:
Study pop:
Patients diagnosed with rectal cancer at The Sixth Affiliated Hospital, Sun Yat-sen
University and Nanfang Hospital, Southern Medical University will be assessed for
suitability for inclusion.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
18-75 years of age. Rectal cancer with pathological diagnosis. Patient will undergo
sphincter-preserving therapies. ECOG score for performance status is 0-2. Written
informed consent.
Exclusion Criteria:
Patients who have undergone rectal cancer surgery. Patients who have received pelvic
radiotherapy. Patients with other active malignant tumors. Recently (less than 4 weeks)
received surgery or patients with recent severe trauma.
Significant cardiac disease: congestive heart failure of New York Heart Association class
≥2; patients with recent (less than 12 months) active coronary artery disease (unstable
angina or myocardial infarction).
Recent (less than 6 months) thrombosis or embolism events, such as cerebrovascular
accident (including transient ischemic attack), pulmonary embolism and deep vein
thrombosis.
Patients with toxicity (CTCAE Grade ≥ 2) caused by previous treatment that has not
subsided.
Pregnant or lactating women.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
January 1, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Sixth Affiliated Hospital, Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Source:
Sixth Affiliated Hospital, Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05671809
