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A Prospective Controlled Clinical Study:Comparing Conventional Auxiliary Incisions with Stoma Localization Auxiliary Incisions

A Prospective Controlled Clinical Study:Comparing Conventional Auxiliary Incisions with Stoma Localization Auxiliary Incisions

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097620
Enrollment
Unknown
Registered
2025-02-21
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-02-24

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

Conditions

Low Rectal Cancer

Interventions

Experimental Group:Study participants underwent elective laparoscopic Total Mesorectal Excision(TME).During the surgery,an auxiliary incision was made at the stoma site,part of the incision was suture
Control Group:Study participants underwent elective laparoscopic Total Mesorectal Excision(TME).During the surgery,a conventional auxiliary incision(midline lower abdomen)was made to remove the tumor

Sponsors

Department of Colorectal Surgery,First Affiliated Hospital of Naval Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Age over 18 years at the time of diagnosis; (2) Preoperative biopsy pathological diagnosis of rectal adenocarcinoma; (3) Underwent MRI evaluation before surgery, and the lower edge of the tumor was not more than 10cm away from the anal margin; (4) Undergo elective laparoscopic TME for colon-rectal anastomosis, and do not detach the colon in the splenic area during the operation; (5) Baseline clinical stage TNM PHASE I.-III: CT1-4N0-2M0 (AJCC-8version); (6) Heart, lung, liver, and kidney function can tolerate surgery; (7) Patients and their families are able to understand and are willing to participate in this clinical study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc., requiring emergency surgery; 2. Patients whose tumors involve adjacent organs and require combined organ resection; 3. Patients with tumor recurrence or distant metastasis; 4. Patients with multiple colorectal cancers; 5. History of inflammatory bowel disease or familial adenomatous polyposis; 6. Patients who have participated in or are participating in other clinical trials within 4 weeks prior to enrollment; 7. ASA grade greater than grade III 8. Performance status: Karl Fischer score less than or equal to 60, or ECOG score greater than or equal to 2; 9. Hepatic dysfunction with a MELD score greater than 12 points; 10. Have a history of severe mental illness; 11. Pregnant or lactating women; 12. In the opinion of the investigator, the patient is not suitable to participate in the study due to other conditions.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative stoma complications;

Secondary

MeasureTime frame
Lengths of the two different types of auxiliary incisions;Postoperative pain score;Incidence of postoperative incisional complications;Time to postoperative incision healing;Intra-abdominal adhesion status at the time of stoma reversal surgery;

Countries

China

Contacts

Public ContactZheng Lou

Department of Colorectal Surgery,First Affiliated Hospital of Naval Medical University

louzhengpro@126.com+86 138 1767 4281

Outcome results

None listed

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