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A randomized controlled trial of Preoperative Preparation Prior to Ileostomy Closure after low anterior resection of rectal cancer with ileostomy

Efficacy of stimulation of the efferent limb and rehabilitation procedure before ileostomy closure in rectal cancer patients underwent low anterior resection of rectum and temporary ileostomy: A phase II, single center, randomized controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040501
Enrollment
Unknown
Registered
2020-12-01
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer

Interventions

Preoperative Preparation group (experimental group):endoluminal draining after surgery
Preoperative Preparation group (experimental group):digital anal dilatation
Preoperative Preparation group (experimental group):efferent loop stimulation
Preoperative Preparation group (experimental group):anal sphincter exercise
Routine waiting group (control group):Routine waiting

Sponsors

Peking University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. ECOG Performance status 0-1; 3. Histologically confirmed diagnosis of adenocarcinoma of the rectum; 4. The distance from down verge of tumor to anal-rectal junction (ARJ) <=8cm based on MRI, or <=12 cm based on sigmoidoscopy; 5. Accepted neoadjuvant chemoradiotherapy before LAR; 6. Patients must read, agree to prior to participation in this study, and sign a statement of Informed Consent; 7. Preoperative endoscopy confirmed no anastomosis leakage before ileostomy closure; 8. Ileostomy was performed in LAR surgery and the ileostomy closure was completed in 6th month after operation.

Exclusion criteria

Exclusion criteria: 1. Live cirrhosis or malfunction of anticoagulation system; 2. Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study; 3. Recurrent rectal cancer.

Design outcomes

Primary

MeasureTime frame
sum of anastomotic stricture rate before ileostomy closure and rate of postoperative ileus after ileostomy closure.;

Secondary

MeasureTime frame
time to resume diet after ileostomy;time to resume diet after ileostomy;time in order to reduce postoperative complications;time of hospital stay;LARS score;Wexner score;

Countries

China

Contacts

Public ContactZan Tiancheng

Peking University Cancer Hospital

zlzhantiancheng@163.com+86 13911377261

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026