The Efficacy of Antegrade and Retrograde Enemas Management in Low Anterior Resection Syndrome and Improving the Rate of Ileostomy Reversal

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSichuan Cancer Hospital and Research Institute

About this trial

Anterior rectal resection has become the primary surgical treatment for rectal cancer. However, studies have reported that up to 80%-90% of patients who undergo anterior rectal resection experience varying degrees of defecation dysfunction after surgery, such as frequent bowel movements, urgent bowel movements, and faecal incontinence, known as low anterior resection syndrome (LARS). This can lead to a decline in quality of life after surgery and even partial loss of social functioning.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

According to the NCCN guidelines for the pathological diagnosis of rectal cancer, the patient has primary rectal adenocarcinoma;

Age ≥ 18 years;

Previously underwent rectal resection with prophylactic ileostomy via laparoscopy, robotics, or open surgery;

Expected to undergo ileostomy reversal surgery within 1-2 months;

Disqualifiers

American Society of Anesthesiologists (ASA) classification III or higher;

Concurrent inflammatory bowel disease, Crohn's disease, or other intestinal diseases;

Mental disorders, long-term use of psychiatric drugs;

Contraindications to enemas.

Trial design

Design model

Parallel

Treatments tested in this trial

  • antegrade enema

    Other intervention

    Introduce saline at a flow rate of 40 ml/minute through the distal end of the ileostomy. The initial enema volume is approximately 500 ml, with a maximum of 1000 ml. Perform twice weekly for one month.

  • retrograde enema

    Other intervention

    Introduce saline at a flow rate of 40 ml/minute through the anus. The initial enema volume is approximately 500 ml, with a maximum of 1000 ml. Perform twice weekly for one month.

Treatment groups

72 Participants
are divided into 3 treatment groups
Group A: standard of careNo intervention 0 interventions
Group B: antegrade enemaExperimental treatment 1 intervention
Group C: retrograde enemaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Success rate of ileostomy reversal

Time frame
Two months after the last enema
2

low anterior resection syndrome score (LARS score)

The LARS score consists of five components and the total score, ranging from 0 to 42. Severity levels are categorized as follows: no LARS (0-20 points), minor LARS (21-29 points), and major LARS (30-42 points).

Time frame
Evaluations were conducted one day before enema, one month after enema, one month, two months, three months, and six months after stoma closure.

Secondary outcomes

1

quality of sleep

Quality of sleep was evaluated by Pittsburgh Quality Index (PSQI). The PSQI assesses a participant's sleep quality in the previous month using 18 items divided into 7 components. Each component is graded between 0 and 3. The total score is 0-21, with higher scores indicating poorer sleep quality.

Time frame
Evaluations were conducted one day before enema, one month after enema, one month, two months, three months, and six months after stoma closure.
2

bowel function

The Memorial Sloan-Kettering Cancer Center Bowel Function Instrument (MSKCC BFI) is used to assess bowel function. This questionnaire comprises three dimensions, totaling 18 items. The total scale score ranged from 18 to 90, with higher scores indicating better bowel function.

Time frame
one month, two months, three months, and six months after stoma closure.
3

cancer patients' quality of life

The quality of life was assessd by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer 29 (EORTC QLQ-CR29). The scale includes 4 functional domains, 19 symptom domains, and 6 stoma-related items. Each item, except for item 18 (which indicates the presence or absence of a stoma), is rated on a 4-point scale: 'not at all,' 'a little,' 'quite a bit,' and 'very much,' corresponding to scores of 1 to 4, respectively. Scores are converted into standardized values ranging from 0 to 100 using polarization. Higher scores in the functional domains indicate better function, whereas higher scores in the symptom domains reflect more severe symptoms.

Time frame
one month, two months, three months, and six months after stoma closure.

Other outcomes

1

The psychosocial adjustment level of patients with enterostomy

The psychosocial adjustment level of patients with enterostomy were evaluated using the Ostomy Adjustment Inventory-20 (OAI-20). OAI-20 adopts a 5-level Likert scoring method, forward scores range from 0 (strongly disagree) to 4 (strongly agree), while reverse scores range from 4 (strongly disagree) to 0(strongly agree). Total scores range from 0 to 80, where scores \<40 indicate low psychosocial adjustment, scores between 40 and 59 indicate medium psychosocial adjustment, and scores ≥60 indicate high psychosocial adjustment levels.

Time frame
Evaluate one day before starting enemas and one month after enemas before performing stoma closure.
2

The Stoma-Specific Quality of Life

The Stoma-Specific Quality of Life-Questionnaire (Stoma QoL) was designed specifically for patients with ostomy and consists of 20 entries, each of which is divided into 4 levels: always, sometimes, rarely, never, with a score ranging from 1 to 4. The ratings range from 20 to 80, with higher levels indicating higher HRQoL.

Time frame
Evaluate one day before starting enemas and one month after enemas before performing stoma closure.
3

Observation chart for anal excretion and irritation symptoms during ostomy (self-made)

This was designed to assess anal feces and discomfort sensations in stoma patients during their stoma time. The questionnaire consisted of four main questions dealing with frequency of defecation, perception of bowel movement, sensation of irritation in the anal region, and the patient's reaction to irritants. These four specific questions as follow: 1. In the last week, how often have you felt discharge oozing from around your anus? 2. In the last week, how often have you felt a bowel movement around your anus? 3. In the last week, how often have you felt irritation in your bowel movements? 4. Do you experience skin irritation or discomfort from anal discharge? (five-point scale: "very", "rather", "generally", "somewhat", "not at all")

Time frame
Evaluate one day before starting enemas and one month after enemas before performing stoma closure

Locations

This trial has no locations.

Sponsors and contacts

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