An Exploratory Study on the Recovery of Intestinal Flora and Intestinal Function by Preventing Stoma Discharge Reinfusion After Sphincter Preservation for Middle and Low Rectal Cancer
Phase: NA
Conditions: Rectal Cancer
Sponsor: The First Hospital of Jilin University

Impact on the recovery of bowel function after
anal reinfusion of prophylactic stoma drainage
fluid after anal preservation surgery for middle
and low rectal cancer (STARS-RC04)
Research protocol
Head of Research: Wang Quan
Organiser: the First Hospital of Jilin University
NCTnumber: NCT05461248
Version number: 1.3
Version date: 30 July 2022

Confidentiality statement
The ownership of all information contained in this protocol belongs to
the First Hospital of Jilin University, and will be provided only for review
by the investigators, co-investigators, ethics committees, and supervisory
and management authorities and other relevant medical institutions.
Without written approval from the First Hospital of Jilin University, it is
strictly prohibited to communicate any information to third parties
unrelated to this study, except for necessary explanations to subjects who
may participate in this study when signing the informed consent form.

I. Background to the study
Colorectal cancer is one of the common malignant tumours of the digestive
tract in China, and its incidence rate ranks 3rd in the country and is on the rise year
by year, with an annual incidence of 388,000 people in 2015, of which rectal
cancer accounts for more than half of the total1. The incidence of rectal cancer in
China is characterised by the predominance of middle and low rectal cancer,
accounting for about 70% of the total number of cases. At present, surgery is still
the main treatment mode for rectal cancer. Anastomotic leakage (AL) has been a
hot issue in colorectal surgery.2 Anastomotic leakage is defined as a disruption or
loss of bowel wall integrity at the site of colorectal or colorectal-anal tube
anastomosis, which results in interstitial communication (including leakage at the
site of reconstruction of the rectal pouch suture, e.g., J ⁃ pouch), and the
development of a pelvic abscess adjacent to the anastomosis site.3 AL is a common
and serious complication after anal preservation surgery for rectal cancer, with an
incidence of 6.7%-16.7%.4-5 The morbidity and mortality rate after AL can be up to
16%.6 The 2019 Chinese Expert Consensus on the Diagnosis, Prevention, and
Management of Anastomotic Leakage in Rectal Cancer Surgery identifies the
protective stoma as a protective factor against anastomotic leakage.2 .
Protective stomas are most common with collared ileostomies, defined as ileal
collars that are fixed to the skin surface and create an opening to allow bowel
contents to flow out through the artificial stoma. The purpose is to protect the
anastomosis between the colon and the rectum or anal canal. Ileostomies require a
secondary surgical closure in addition to triggering temporary care problems. The
incidence of surgical complications ranges from 11% to 45%, with a mortality rate
of 0.06% to 6.4%7-10. The most common postoperative complication is intestinal
obstruction. Bowel obstruction not only directly causes physical and psychological
pain, but also leads to increased rates of nosocomial infections, other
surgery-related complications, postoperative mortality, and hospitalisation costs.
A large number of beneficial bacteria (e.g. Bifidobacterium, Lactobacillus,
etc.) normally exist in the human intestinal tract, which are not only non-toxic and

harmless to the organism, but also participate in the process of digestion, nutrition,
metabolism, absorption, immunity and anti-infection of the host. Research has
proved that it plays an important role in maintaining a healthy microecological
balance of the organism. The intestinal flora is essential for the maintenance of the
host's physiological processes, including the epithelial barrier and immune
function11 . The stressful effects of surgery can cause damage to the intestinal
mucosa, and an absent intestinal segment following a protective stoma can weaken
intestinal motility, leading to a proliferation of pathogenic intestinal flora and
causing intestinal dysbiosis12 .
Previous studies have shown that the mucosa and villi of the open bowel
segments after intestinal diversion produce atrophy, decreased absorptive capacity,
and loss of rhythmic contractions. It has been suggested that transanal irrigation
may help to prevent and control colorectal anastomotic fistulae and improve
patients' postoperative life quality16-18 . Accordingly, it is hypothesised that if
preoperative stimulation of stoma discharge reinfuison to the open bowel segment
through the anus may help to promote the recovery of bowel function and intestinal
flora disorders after stoma closure surgery.
To address this hypothesis, in the present study we propose to conduct a
prospective, randomised controlled study in patients with protective stoma, aiming
to investigate whether stimulation of stoma drainage fluid through the anus to an
open intestinal segment prior to stoma closure is beneficial for the recovery of
bowel function, reduction of complications and improvement of intestinal
dysbiosis, and to provide high-level evidence for the clinic.
II. Purpose of the study
To analyse the occurrence of defecation complications, rectal function and
quality of life indicators after collecting stoma discharge for anal re-infusion to
patients after performing protective ileostomy in anus-preserving surgery for
middle
and low rectal cancer, so as to evaluate the impact of collecting stoma drainage fluid
for anal re-infusion on the recovery of patients' intestinal function.

III. Subject of the study
(i) Inclusion criteria
1. Age: 18~75 years old, male or female;
2. Pathological diagnosis of adenocarcinoma of the rectum on preoperative
biopsy;
3. Clinical staging was T1-4aN0-2M0;
4. No distant multiple metastases;
5. ECOG rating 0-2;
6. Cardiac, pulmonary, hepatic and renal functions met the criteria for surgical
tolerance
7. Clinical diagnosis of middle and low rectal cancer, the lower edge of the
tumour is within 10cm from the anal verge, and it is proposed to perform radical
rectal surgery and prophylactic ileostomy at stage I, and intestinal closure at stage II;
8. Patients and their families were able to understand and willing to participate in
this clinical study and signed an informed consent form.
(ii) Exclusion criteria
1. Previous history of malignant colorectal tumour or recently diagnosed
combination of other malignant tumours;
2、Patients with combined intestinal obstruction, intestinal perforation, intestinal
haemorrhage, etc. requiring emergency surgery;
3. Neighbouring organs requiring combined organ removal;
4. ASA classification ≥Grade IV and/or ECOG physical status score > 2;
5. Those who have serious liver and kidney dysfunction, cardiopulmonary
dysfunction, coagulation dysfunction or combined serious basic diseases cannot
tolerate the surgery;
6. Have a history of serious mental illness;
7. Pregnant or breastfeeding women;
8. Those who have a history of taking steroid drugs;

9. Patients with other clinical and laboratory conditions considered by the
investigator to be inappropriate for participation in the trial;
10. One week before the operation, there are signs of infection, body temperature
rises >37.5°C, blood WBC >10.0×109/L;
11. History of antibiotic use 1 week prior to surgery (excluding preoperative
shock medication);
12. Preoperative neoadjuvant patients
(iii) Exit criteria
1. Accompanied by other non-oncological conditions that make it impossible for
the patient to continue to receive this treatment plan;
2, After enrolment in the study, patients who required emergency surgery due to
intestinal obstruction, perforation, or bleeding,et al. prior to stoma closure;
3. Patients with pathologically confirmed distant metastases after rectal surgery,
including liver, pelvis, ovary, peritoneum, and distant lymph node metastases;
4. Intraoperative exploration for middle and low rectal cancer in anus-preserving
surgery for those who need combined organ resection;
5. After enrolment in the study, patients requested to withdraw from the study
cohort for various reasons, or were unable to complete the study programme and
follow-up for various reasons;
6. Anastomotic fistula, severe anastomotic stenosis (inability to pass through
enteroscopy or oesophageal finger and inability to dilate via oesophageal finger) after
radical rectal surgery.
IV. Study endpoints
(i) Primary study endpoints:
Incidence of major LARS after 6 months of stoma closure.
(ii) Secondary research endpoints:
1, Bacteriological sequencing 1 month after stoma closure

2. Anorectal function (LARS questionnaire, Wexner15 incontinence score,
MSKCC13-14 bowel function questionnaire), Glazer pelvic floor muscle surface
electromyography, and quality of life scores after 1 month of stoma return.
3. Recovery of postoperative bowel function
After reversal surgery, time to oral feeding, time to anal defecation after
reduction surgery, and rate of intestinal obstruction (intestinal obstruction was defined
as ,inability to tolerate food for more than 72 H or the need for re-fasting or
gastrointestinal decompression) were observed.
V. Research design
The study was a prospective randomised design with simple randomised grouping,
randomised by prior computer-generated random number tables. The expected
recruitment cut-off date for all subjects was 1 November 2022, with a predictable
sample size of 60 cases to be enrolled based on patient admissions to the hospital. The
enrolment process is as follows

(i) Transanal reinfusion of stoma discharge
Experimental group:
Starting from 1 month after radical rectal surgery, the infusion is performed once
a week for 2 months. Each infusion was performed with a liquid diet on the day
before, and 400-600 mL of stoma discharge was collected on the same day (if the
stoma fluid was limited, it could be blended with warm water), and the reinfusion was
performed from the patient's anus using an enema bag, with a flow rate of about 100
mL/min being controlled.
Control group:
No special treatment.
(ii) Preoperative preparation for protective stoma reduction
Stoma closure was performed 3 months after surgery. All patients were reviewed
in an outpatient clinic at least 7 days before preparation for stoma closure.
The surgeon is responsible for performing rectal palpation and Lower
gastrointestinal tract imaging to rule out anastomotic leakage and anastomotic
stenosis.
(iii) Pelvic floor muscle function assessment
Pelvic floor muscle function tests were performed "prior to radical rectal
surgery", "prior to stoma closure surgery","1 month after stoma closure surgery", "3
months after stoma closure surgery" and "6 months after stoma closure surgery"to
compare the recovery of pelvic floor muscle function.
(iv) Sequencing of intestinal flora
faecal sampling
Gut microbiological samples were collected using the rectal swab method. Firstly,
the perianal area was cleaned using soap, water and 70% alcohol respectively, then a
sterile swab was inserted into the anus 4-5cm at the anal sphincter after moistening
with saline and gently rotated to take a sample at the anal crypt (traces of faeces were
clearly visible on the swab), then inserted into a sterile freezing tube (or the head of
the swabs was clipped and dropped into a sterile freezing tube, 3-5 swabs were
provided for each sample) and placed in a box containing ice/ dry ice in a foam box,

transported to the laboratory within 24h and stored in a -80°C refrigerator.
Sample delivery
A. DNA: total amount >500ng, concentration >20ng/ul, no significant degradation, 2g
of faecal or intestinal contents;
B. The sample volume of a single delivery should be ≥20 samples, the delivery tube
(freezing tube) must be clearly labelled with the sample number, the mouth of the tube
should be sealed with Parafilm sealing film (to prevent cross contamination between
samples), and the completed delivery order should be sealed in a self-sealing bag and
sent to the laboratory with the samples transported on dry ice.
sampling node
Before radical rectal surgery, before stoma closure surgery, and 1 month after
stoma closure surgery.
(v) Hospitalisation and discharge criteria after stoma closure surgery
1. Hospitalisation
Discontinue all IV medications on postoperative day 2 if they meet the
following criteria:.

Haemodynamically stable

Temperature < 37.3 degrees Celsius

Pain score < 5 (on a scale of 0 to 10)

Tolerates oral diet without nausea or vomiting

Clear urination
If all criteria are not met the morning after surgery, the patient will continue
rehydration, anti-infective, and pain control therapy until the criteria are met. In
addition, even if all criteria for stopping intravenous medication are met, treatment
may continue to be given if the surgeon feels that it would be beneficial for the patient
to have continued treatment. Patients are checked in daily to see how they are doing to
ensure they are progressing well.
2. Discharge criteria
The patient is in good general condition, basically resuming normal diet and
intestinal function; body temperature is normal and there are no positive signs on

abdominal examination; relevant laboratory findings are basically normal; and the
abdominal incision is healing well (II/A or II/B).
(vi) Adverse events
1. The patient is unable to operate the transanal reinfusion process
Treatment: Each patient who needs transanal reinfusion will have the first
process performed by the doctor, who will instruct the patient and his/her family on
the spot. The doctor and the patient leave each other's phone number or WeChat to
keep in touch.
2、Abnormalities in the patient's transanal reinfusion
Handling: If the patient has abdominal distension or the urge to defecate during
transanal reinfusion, the patient should be instructed to take deep breaths to alleviate
the discomfort. During transanal reinfusion, pay attention to the patient's condition
changes at any time, such as the discovery of rapid pulse, pallor, cold sweat, severe
abdominal pain, panic and shortness of breath, you should immediately stop the
enema and contact the doctor in time to take emergency measures.
VI. Follow-up programme
Functional learning follow up:
(1) Items: including LARS score, Wexner incontinence score, MSKCC bowel
function questionnaire; quality of survival score. The questionnaire follow-up was
conducted by a professional pelvic floor follow-up team. The investigators of the
pelvic floor follow-up team had appropriate professional training and were unaware
of the patient grouping. The method of answering the questionnaires was explained to
the patients before the questionnaire assessment, and after detailed enquiry, the
patients were asked to answer the questionnaires in a specific way.
(2) Time: before radical rectal surgery, 1 month after stoma closure, 3 months
after stoma closure and 6 months after stoma closure.
Survival follow-up:
Patient survival at 1 year post-stoma closuren, 2 years post-stoma closure, 3
years post-stoma closure, and 5 years post-stoma closure follow up.
VII. Observation indicators

1. Baseline information: gender, age, height, weight, ASA, past medical and
treatment history, co-morbidities, laboratory tests and imaging.
2. Sequencing of intestinal flora: before radical rectal surgery, before stoma
closure, and 1 month after stoma closure.
3. Perioperative period: also include time to first postoperative defecation, time to
first postoperative semi-liquid diet, and incidence of postoperative intestinal obstruction.
4. Follow-up indicators: LARS syndrome score, Wexner score, MSKCC Bowel
Function Questionnaire, QLQ-C30 Quality of Life Scale.
VIII. Signing of informed consent and registration of subjects
(i) Informed consent signing:
The study will be conducted in accordance with clinical trial protocols, GCP
principles and the Declaration of Helsinki. The informed consent form will be signed by
the PI or a qualified, trained and authorised clinical staff member. The trial process
needs to be explained in detail to the subject and/or authorised person, and it is
important to avoid over-informing and to give the subject and/or authorised person
enough time to consider whether to participate or not. Subjects/authorised persons will
be enrolled in the experimental group once they have agreed and signed the informed
consent form. The original informed consent form is kept on file at the research centre
and a copy is retained by the subject.
(ii) Subject registration
After signing the informed consent form, patients are registered with subject
information, baseline data, and oncology-related data, which should include all data
from the screening phase of this study.
IX. Sample size calculation
The sample size was calculated using PASS 15 software, with the major LARS
incidence rate at 6 months after stoma closure surgery as the primary outcome. Based on
retrospective data from the authors’ centre, the major LARS rate at 6 months after
stoma closure surgery was estimated to be 14% in the stoma discharge reinfusion group
and 47% in the control group. Thus, a sample size of 27 patients was required to achieve
80% power in detecting differences, with a two-sided level of significance of 0.05.

Assuming a dropout rate of up to 10%, 60 patients were enrolled.
X. Methods of statistical analysis
(i) Definition of analysis set
1. Full Analysis Set (FAS)
According to the basic principle of intentional analysis (ITT), all enrolled subjects
who were given a randomisation number will be included in the FAS. the FAS is the
primary dataset for the evaluation of the efficacy of this study.
2. Compliance with the programme set (Per-Protocol Set, PPS)
PPS is defined as all cases in which planned treatment and visits were completed as
specified in the protocol and there were no protocol violations that significantly affected
outcomes. Patients with protocol violations that significantly affect the protocol will be
excluded from this analysis set. Protocol violations that significantly affect efficacy will
be identified at the time of data review. PPS is a secondary data set for the efficacy
evaluation of this study.
3. Safety Set (SS)
Cases that completed at least one safety evaluation data after enrolment constituted
the safety population of this study. The safety population was the primary population for
the safety evaluation of this study.
(ii) Methods of statistical analysis
1. General principles: All statistical tests will be two-sided, and P< 0.05 will be
considered statistically significant for the differences tested. The description of
quantitative indicators will calculate the mean, standard deviation, median, minimum
value, maximum value, if it meets the normal variance chi-square, expressed as the
mean ± standard deviation, and use the t-test to compare the differences between the
two groups; data that do not meet the normal variance chi-square are expressed as the
median (quartile), and the rank sum test is used for comparison. Categorical indicators
were described by the number of cases and percentages in each category, and the
chi-square test was used to compare the differences between the experimental and
control groups.
2, The main outcome indicators of the occurrence of LARS at 6 months after the

reduction were expressed as the number of cases (percentage), and the chi-square test
was used to compare the differences between the experimental group and the control
group.
Secondary outcome indicator colony species results will be tabulated based on the
top 15 species in abundance using cumulative histograms to compare species
composition differences between samples. Based on the species abundance information
of each sample at the genus level, the top 50 genera of abundance will be selected, and
the samples and species will be clustered based on the abundance information of each
sample, and heat maps will be drawn. And Shannon diversity index, Simpson index and
Chao1 richness index were calculated for Alpha diversity analysis Comparative analysis
of microbial community composition of samples between different groups was
performed using Beta diversity analysis.
Secondary
outcome
indicators
Wexner
score,
MSKCC
Bowel
Function
Questionnaire, and QLQ-C30 Quality of Life Scale scores were analysed for
repeated-measures data between the two groups, Mauchly's test of sphericity was
performed, and ordinary one-way ANOVA or multifactorial ANOVA was performed
according to the test results.

x. schedule of visits
sports event
Pre-radi
cal
rectal
surgery
pre-discha
rge
Pre-sto
ma
closure
surgery
Post-sto
ma
closure
1 month
Post-sto
ma
closure
3
months
Post-sto
ma
closure
6
months
Demographic
information
√
Baseline
assessment
√
bacterial
colony
sequencing
√
√
√
Pelvic
floor
muscle
examination
√
√
√
√
√
surgical
treatment
√
postoperative
pathology
√
postoperative
follow-up
√
√
√

rectal
examination
√
√
√
√
Pelvic
floor
surface
electromyogr
aphy
assessment
√
√
√
√
√
Functioning,
quality of life
questionnaire
√
√
√
√

Schedule 1
LARS Bowel Function
Questionnaire
Does the patient complain of abnormal bowel movements: □Yes
□No
Patient complained of abnormal defecation as: □increased frequency □
incontinence □painful defecation □inability to distinguish between gas
and faeces □other
Whether the patient is satisfied with the current state of defecation: □
Satisfied □Unsatisfied
Does the patient think that the current
state of defecation affects daily life:
□No effect □Yes effect
Use of medication to improve bowel
movements: 
Yes Name
□No
Prophylactic fistula □Yes □No
Prophylactic Fistula Payback Time 
is time
Year
Month Day

No
1.
Have you ever had uncontrollable flatulence (farting)?
□Never
0
points
Yes, less than 1 time per week
4
points
Yes, at least once a week
7
points
2.
Have you ever had an accidental leakage of loose stool?
□Never
0
points
Yes, less than 1 time per week
3
points
Yes, at least once a week
3
points
3.
How many times a day do you have a bowel movement?
□More than 7 times per day (24 hours)
4
points
□4~7 times per day (24 hours)
2
points
□1~3 times per day (24 hours)
0
points
□Less than 1 time per day (24 hours)
5

points
4.
Have you ever had to have another bowel movement within an hour of having one?
□Never
0
points
Yes, less than 1 time per week
9 points
Yes, at least once a week
11
points
5.
Have you ever had to flush to the loo because of an urgent bowel movement?
□Never
0
points
Yes, less than 1 time per week
11
points
Yes,at least once a week
16
points
The total score of the questionnaire was calculated by adding the scores of the 5
items. A total score of 0-20 indicates "no anterior resection syndrome", and a score
of 21-29 indicates "no anterior resection syndrome".
"Mild anterior resection syndrome", 30-42 means "severe anterior resection syndrome".
LARS Rating:
Points
Functional
classification □N o LARS
□Mild LARS

Severe LARS

Schedule 2
ASA Classification Criteria
Refers to the six classes into which the American Society of Anaesthesiologists (ASA)
classifies patients prior to anaesthesia based on their physical condition and risk to surgery.
(military)
rank
condition
Perioperative
mortality
rate
first
level
Physical health, good development and nutrition, and
normal functioning of organs.
0.06 per cent-0.08 per
cent
second
level
In addition to surgical disease, there is mild coexisting
disease with sound functional compensation.
0.27 per cent - 0.40 per
cent
third
level
Coexisting conditions are severe and physical activity is
limited, but can still manage daily activities.
1.82 per cent-4.30 per
cent
fourth
level
Severe coexisting conditions, loss of ability to perform
daily activities, and frequent life-threatening situations.
7.80 per cent-23.0 per
cent
fifth
level
Dying patients who have difficulty sustaining life for 24
hours, with or without surgery.
9.40 per cent-50.7 per
cent
sixth
level
Confirmed brain death and his organs are intended for
organ transplants.
First and second class patients tolerate anaesthesia and surgery well and pass through
anaesthesia smoothly.
Anaesthesia for Class III patients carries certain risks, and it is important to make
adequate preparations before anaesthesia, and to take effective measures to actively prevent
any complications that may occur during anaesthesia.
Class IV patients are extremely dangerous to anaesthesia and have a high perioperative
mortality rate even with adequate preoperative preparation.
Grade 5 is a dying patient who is unusually dangerous to anaesthesia and surgery and
should not undergo elective surgery.

Schedule 3:
ECOG Physical Fitness Status Scale
(military)
rank
functional status
0
Mobility was completely normal and did not differ in any way from the mobility before
the onset of the disease.
1
Can move around freely and perform light physical activities, including general
household or office work, but cannot perform heavier physical activities.
2
(b) Tolerates the symptoms of the tumour, is able to move freely and take care of
himself, is incapacitated for work, but spends no more than 50 per cent of his time in
bed during the day.
3
The tumour is so symptomatic that it is bedridden or wheelchair-bound for more than
50 per cent of the day, but it is still able to get up and stand, and is only partially
self-sufficient.
4
Seriously ill and bedridden, unable to care for himself.
5
Death.

Schedule 4:
Wexner Constipation Score
frequency of defecation
1-2 times every 1-2 days
0 □
2 times per week
1 □
1 time per week
2 □
Less than 1 time per week
3 □
Less than 1 time per month
4 □
Difficulty: pain
assessment
Never
0 □
Very little
1 □
Sometimes
2 □
Usually
3 □
Always
4 □
Completeness: incomplete sensory
assessment
Never
0 □
Very little
1 □
Sometimes
2 □
Usually
3 □
Always
4 □
Pain: Abdominal pain
Never
0 □
Very little
1 □
Sometimes
2 □
Usually
3 □
Always
4 □
Time: time in toilet (min)
Less than 5
0
□
5-10
1
□
10-20
2
□
20-30
3
□
Greater than 30
4
□
Auxiliary: auxiliary forms
No
0 □
Stimulant laxatives
1 □
Finger-assisted or enema 2 □
Failure: number of
failed defecation attempts in 24h
No
0 □
1-3 times
1 □
3-6 times
2 □
6-9 times
3 □
More than 9 times
4 □
Medical history: duration of
constipation (years)
0
0 □
1-5
1 □
5-10
2 □
10-20
3 □
More than 20
4 □
Total Score:

Schedule 5:
Bowel symptoms (MSKCC
Bowel Function Questionnaire)
Always/often
Sometimes/rarely
non-occurrence
constipation
When you feel like having a bowel movement,
can you wait 15min before going to the toilet?
Do you have another bowel movement within 15
minutes after the previous one?
Are your bowel function issues affecting your
daily activities?
During the day, do you ever use tissues,
nappies or pads under your underwear to
prevent leakage?
Have you ever had loose stools? (Slightly
formed, paste-like)
Have you ever soiled your underwear during
the day?
Have you ever had diarrhoea? (unformed,
watery stools)
Have you ever soiled (leaked) your underwear
while sleeping?
Have you ever used medication (e.g.
diarrhoea, antidiarrhoea) to reduce the
frequency of bowel movements?
Bowel movements are affected by
diet
Have you ever controlled your bowel movements
by limiting the types of solid foods you
consume?
Does the intake of certain solid foods
increase the number of bowel movements per
day?
Have you ever controlled your bowel movements
by limiting the types of liquid foods you
consume?
Does drinking a certain liquid increase the
number of bowel movements per purpose?
Abnormal bowel movements

Do you go to the toilet regularly?
Do you feel like you have completely emptied
your bowels after a bowel movement?
Can you control your bowel movements?
Do you know the difference between the
sensation of having to pass gas (fart) and
having a bowel movement?

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