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NCT Number: NCT06717854

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

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Key information

Conditions

Low Anterior Resection Syndrome Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Chengdu, Sichuan, China

Location contact

Hai Hu, M.D.

CONTACT

[email protected]

8613540662185

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Informed consent was obtained for voluntary participation in the study.

Exclusion criteria

  • 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.

Treatment and study plan

transanal irrigation

Other

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

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.

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

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

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

  2. quality of life for rectal cancer patients

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

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

  3. quality of sleep

    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

    Pittsburgh Quality Index (PSQI)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Hai Hu, M.D.

CONTACT

[email protected]

8613540662185

Sponsors and collaborators

Lead sponsor

Sichuan Cancer Hospital and Research Institute

Other

Registry information

Official study title

Retrograde and Antegrade Enema for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a Single-Center, Prospective Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2024
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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