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A clinical study on the optimal timing for closure of temporary ileostomy after radical surgery for rectal cancer

A clinical study on the optimal timing for closure of temporary ileostomy after radical surgery for rectal cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097790
Enrollment
Unknown
Registered
2025-02-25
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Rectal cancer

Interventions

Early Reversal Group (Before Adjuvant Therapy):Closure of the ileostomy before the initiation of adjuvant therapy, specifically 8–16 days after rectal surgery.
Late Reversal Group (After Adjuvant Therapy):Closure of the ileostomy within 15–60 days after the completion of adjuvant therapy.

Sponsors

People’s Hospital of Deyang City
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with rectal cancer who have undergone radical anterior rectal resection (R0 resection) and temporary ileostomy at the same time have no clinical manifestations of anastomotic leakage after surgery. Age & Physical Condition: 1. Age>=18 years old, with independent informed consent capacity; 2. Physical condition meets the indications for adjuvant therapy (ECOG score 0-1 points); 3. Indications for adjuvant therapy: according to postoperative pathological results and clinical evaluation, there are indications for adjuvant chemotherapy; 4. Willing to participate in this study and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: Poor general condition: 1. ASA score > 3, indicating high risk of surgery or anesthesia; 2. ECOG score >=2 points, indicating poor physical functional status. Advanced or complex tumors: 1. UICC tumor stage is stage IV; 2. Anastomotic leakage or other serious complications after surgery. Other medical contraindications: 1. Presence of severe and uncontrollable systemic disease (such as heart failure, renal failure, or active infection); 2. Have other serious psychological or psychiatric disorders that affect treatment compliance.

Design outcomes

Primary

MeasureTime frame
Chemotherapy Compliance;

Secondary

MeasureTime frame
Stoma-Related Complications;Surgical Complications;Chemotherapy Toxicity;Psychological Status;Quality of Life;Anorectal Function;

Countries

China

Contacts

Public ContactZhang Mingran

People’s Hospital of Deyang City

zhangmingran1991@163.com+86 158 2805 2455

Outcome results

None listed

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