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Clinical study on the retraction time after preventive ileostomy in middle and low rectal cancer

Clinical study on the retraction time after preventive ileostomy in middle and low rectal cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032585
Enrollment
Unknown
Registered
2020-05-03
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-05-04

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

Conditions

rectal cancer

Interventions

15 days group:Retraction will be performed at 15 days after prophylactic stoma
3 months group:Retraction will be performed at 3 months after prophylactic stoma
3 months group:Retraction will be performed at 6 months after prophylactic stoma
15 days group(postoperative adjuvant treatment):Retraction will be performed at 15 days after prophylactic stoma to the patients requiring postoperative chemotherapy
3 months group (postoperative adjuvant treatment):Retraction will be performed at 3 months after prophylactic stoma to the patients requiring postoperative chemotherapy
6 months group (postoperative adjuvant treatment):Retraction will be performed at 6 months after prophylactic stoma to the patients requiring postoperative chemotherapy

Sponsors

The First Hospital, China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with middle and low rectal cancer (CT shows that the tumor is located below the peritoneal reflex; colonoscopy shows that the lower edge of the tumor is more than 3 cm within 10 cm of the dentate line). 2. Patients undergoing radical resection of rectal cancer with prophylactic stoma, no signs of anastomotic leakage during perioperative period. 3. TNM staging is I-III. 4. Age is between 18 years old. 5. The retraction time is less than six months from the last ostomy. 6. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. No radical resection. 2. Patients with severe cardiopulmonary dysfunction can not tolerate secondary surgery or tumor recurrence or metastasis is found before surgery.

Design outcomes

Primary

MeasureTime frame
Ostomy complications;Anal functional exercise score;Ostomy retraction rate;Early complications of surgery;Late complications of surgery;Timing of chemotherapy;Medical expenses;

Secondary

MeasureTime frame
ESCA;OAS;PSSS;

Countries

China

Contacts

Public ContactZhou Jianping

The First Hospital, China Medical University

zjphama@163.com+86 13840509519

Outcome results

None listed

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