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A Randomized Controlled Study of Modified Pull - Out Procedure for Low Rectal Cancer After Preoperative Radiotherapy Combined with Colloanal Anastomosis and Prophylactic Colostomy

A Randomized Controlled Study of Modified Pull - Out Procedure for Low Rectal Cancer After Preoperative Radiotherapy Combined with Colloanal Anastomosis and Prophylactic Colostomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100246
Enrollment
Unknown
Registered
2025-04-07
Start date
2025-04-11
Completion date
Unknown
Last updated
2025-04-14

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

Conditions

rectal cancer

Interventions

control group:After complete resection of low rectal cancer, the distal anal canal is closed with a stapler. The proximal colon stump is fitted with the stapler's umbrella part, and after the distal e
experimental group:After complete resection of low rectal cancer, the proximal colon is pulled down near the anus by 3 - 5 cm. The anastomosis is fixed at the sphincter level, with the colon mesentery

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 - 80 years; 2. Pathologically confirmed rectal adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma; 3. Tumor distance from the anal verge <= 7cm or from the dentate line <= 5cm; 4. Patients who have received preoperative chemoradiotherapy and are assessed as eligible for surgical resection after treatment; 5. After preoperative chemoradiotherapy, imaging (MRI/CT) evaluation shows ycT0 - 3N0 - 2M0; 6. Preoperative clinical and imaging assessment shows M1a stage, but the primary rectal lesion can be included in the study if the metastatic lesion can be resected simultaneously or in stages; 7. Good anal sphincter function, with a Wexner incontinence score <= 5; 8. Expected to undergo sphincter - saving surgery and suitable for anastomotic reconstruction; 9. Patients and their families understand the study and voluntarily sign the consent form.

Exclusion criteria

Exclusion criteria: 1.Imaging shows tumor invasion of the external sphincter, levator ani, or puborectalis (T4 stage per anal canal cancer staging); 2.Preoperative clinical and imaging evaluation indicates M1b - M1c stage; 3.History of pelvic radiotherapy or other malignancies; 4.Severe comorbidities (e.g., cardiac, hepatic, or renal insufficiency), ASA score =3; 5.Pregnant or breastfeeding women; 6.Psychiatric illness or poor compliance, making follow - up impossible.

Design outcomes

Primary

MeasureTime frame
The incidence rate of anastomotic leakage;

Secondary

MeasureTime frame
LARS Scoring Scale;The value of Carcinoembryonic Antigen (CEA) ;Tumor staging (T, N, M, overall TNM staging) ;The rate of anastomotic stenosis;The local tumor recurrence rate;The distant metastasis rate;The rate of permanent stoma;

Countries

China

Contacts

Public ContactXiaodong Wang

Department of Gastrointestinal Surgery, West China Hospital, Sichuan University

wangxiaodong@wchscu.cn+86 189 8060 6164

Outcome results

None listed

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