Retrograde and Antegrade Enema for Prevention of LARS After LAR: a Randomized Controlled Trial

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

About this trial

The goal of this clinical trial is to learn if enema works to prevent low anterior resection syndrome (LARS) in adults. The main questions it aims to answer are:

1. To describe the level of stoma adaptation before and after the patients received enemas during the stoma period as well as the levels and trends of LARS, bowel function, sleep quality, and quality of life after stoma reduction surgery 2. To compare the effects and advantages and disadvantages of antegrade and retrograde enema, and to investigate whether these two types of enema can provide safe and effective preventive measures for the prevention of LARS, the improvement of bowel function, and the enhancement of sleep and quality of life in rectal cancer patients after low anterior resection.

Researchers will compare antegrade enema, retrograde enema, and the standard of care to see if these two types of enema work to prevent LARS.

Participants will:

1. Receive either antegrade or retrograde enema or no enema based on the standard of care at 1 month after anterior rectal resection, until the ileostomy reversal. 2. Keep a diary of their symptoms.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Based on the NCCN guidelines for the pathological diagnosis of rectal cancer, patients are identified as having Primary Rectal Adenocarcinoma.

≥18 years.

For the first time, anterior rectal dissection combined with prophylactic ileostomy was performed using laparoscopic, robotic, and open techniques.

The patient exhibits normal cognitive and expressive abilities.

Disqualifiers

American Society of Anesthesiologists (ASA) Class III or higher.

A combination of other intestinal conditions, including inflammatory bowel disease and Crohn's disease.

Mental disorders and prolonged use of psychotropic medications.

The presence of contraindications to enema administration.

Trial design

Design model

Parallel

Treatments tested in this trial

  • transanal irrigation

    Other intervention

    The enema is administered retrogradely via the anus. The enema commences one month post-operatively for patients with well-healed wounds, absence of stoma-related complications, and no evidence of anastomotic leakage upon digital examination, until ileostomy reversal. the catheter is gently and slowly inserted 7-10 cm through the anus. The initial irrigation volume is set at 500 ml and is gradually increased based on the patient's tolerance, up to a maximum of 1000 ml. 39-41°C warm water is the choice. Enemas are administered twice weekly, with each session limited to a duration of 30 minutes.

  • antegrade enema

    Other intervention

    The enema is administered through the distal end of the ileocecal stoma, directed towards the anus. The enema commences one month post-operatively for patients with well-healed wounds, absence of stoma-related complications, and no evidence of anastomotic leakage upon digital examination, until ileostomy reversal. Using a disposable catheter, insert it about 20 cm. The initial irrigation volume is set at 500 ml and is gradually increased based on the patient's tolerance, up to a maximum of 1000 ml. 39-41°C warm water is the choice. Enemas are administered twice weekly, with each session limited to a duration of 30 minutes.

Treatment groups

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

Trial outcomes

Primary outcomes

1

low anterior resection syndrome score (LARS score)

Time frame
Pre-discharge, 1 month, 2 months, 3 months, 6 months after ileostomy reversal

Secondary outcomes

1

bowel function

Memorial Sloan Kettering Cancer Centre Bowel Function Instrument (MSKCC BFI)

Time frame
before anterior rectal resection; 1 month, 2 months, 3 months, 6 months after stoma reversal
2

quality of life for rectal cancer patients

quality of life will be measured using the EORTC Colorectal Cancer Module QLQ-CR29 (EORTC QLQ-CR29 )

Time frame
before anterior rectal resection; 1 month, 2 months, 3 months, 6 months after stoma reversal
3

quality of sleep

Pittsburgh Quality Index (PSQI)

Time frame
before anterior rectal resection, before starting enemas 1 month postoperatively, 2 months, 3-4 months postoperatively; 1 month, 2 months, 3 months, 6 months after stoma reduction

Other outcomes

1

Ostomy Adjustment Inventory-20 (OAI-20)

Time frame
1 month after anterior rectal resection before starting enemas, 2 months and 3-4 months postoperatively
2

A quality of life questionnaire for people with an ostomy (Stoma-QoL)

Time frame
1 month after anterior rectal resection before starting enemas, 2 months and 3-4 months postoperatively
3

Anal drainage and irritation during ileostomy (self-made)

Time frame
1 month after anterior rectal resection before starting enemas, 2 months and 3-4 months postoperatively

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, Afffliated Cancer Hospital of University of Electronic Science and Technology of China Status unavailable Chengdu, SichuanChinaChina

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: