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| ID | Type | Description | Link |
|---|---|---|---|
| 2025KS060 | Other Identifier | Ethics Committee of the Fourth Hospital of Hebei Medical University |
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The aim of this clinical trial is to compare the short- and long-term outcomes of laparoscopic ileocecal reconstruction right hemicolectomy (LIRRH) with those of traditional laparoscopic right hemicolectomy (TRH) for ascending and proximal transverse colon cancer.
This is a prospective, single-center, open-label, randomized controlled clinical trial. Eligible patients will be randomly assigned (1:1) to undergo either LIRRH or TRH and will receive the corresponding surgical procedure.
Primary endpoint: 3-year disease-free survival (DFS).
Secondary endpoints:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIRRH group | Experimental | Participants will undergo laparoscopic ileocecal-reconstruction right hemicolectomy (LIRRH), in which the ileocecal junction is reconstructed; procedure follows the same oncologic resection margins as standard laparoscopic surgery. |
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| TRH group | Active Comparator | Participants will undergo traditional laparoscopic right hemicolectomy (TRH) with standard en-bloc mesenteric resection and ileocolic anastomosis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic ileocecal-reconstruction right hemicolectomy (LIRRH) | Procedure | The ileocolic vessels are divided at their roots, and lymph nodes of stations 203, 202, and 201 are dissected. The right colic and middle colic vessels are also divided at their roots, and the surrounding lymphatic and adipose tissue (stations 211/212/213 and 221/222/223) is cleared. The transverse colon is transected 10 cm distal to the tumor, and the ileum is divided 10 cm proximal to the ileocecal region. After tailoring the ileal mesentery, an end-to-end ileo-transverse colonic anastomosis is performed. Using a seromuscular suture, the ileum and its tailored mesentery are invaginated into the wall of the transverse colon 2 cm proximal to the anastomosis, thereby reconstructing the ileocecal valve complex. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease-free survival (DFS) | DFS is defined as the time from randomization to the earliest date of locoregional recurrence, distant metastasis, second primary colorectal cancer, or death from any cause, whichever occurs first. | From date of randomization until the date of first documented recurrence or death from any cause, assessed up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 10-day postoperative diarrhea rate | The proportion of patients experiencing diarrhea within 10 days after surgery, graded by the Clavien-Dindo classification system. Unit of Measure: % | Within 10 days after surgery |
| 15-day postoperative ileus rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chaoxi Zhou, MD | Contact | +8615931121563 | zhouchaoxi81@163.com | |
| Meng Zesong | Contact | +8615633082765 | mengzesongming@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050000 | China |
The following de-identified individual participant data will be shared: baseline demographics, operative variables, pathologic staging, adjuvant therapy details, recurrence and survival outcomes, and serious adverse events. Data will be provided in CSV format with a data dictionary and variable coding manual.
12 months after primary publication (est. Q4 2027) through 2032 (5 years from sharing).
De-identified IPD, along with the protocol, SAP, and analytic code, will be made available to qualified researchers who provide a methodologically sound proposal, IRB/ethics approval documentation, and a signed data-access agreement. Data will be accessed through a secure, password-protected academic repository (e.g., Zenodo) after approval by the study steering committee.
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Participants are randomized 1:1 to either the LIRRH arm or the TRH arm and followed in parallel until completion of the trial; no crossover or factorial design is employed.
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| traditional laparoscopic right hemicolectomy (TRH) | Procedure | The ileocolic vessels are divided at their roots, and lymph nodes of stations 203, 202, and 201 are dissected. The right colic and middle colic vessels are likewise divided at their roots, and the surrounding lymphatic and adipose tissue (stations 211/212/213 and 221/222/223) is cleared. The transverse colon is transected 10 cm distal to the tumor, and the ileum is divided 10 cm proximal to the ileocecal junction. An end-to-side or side-to-side ileo-transverse colonic anastomosis is then performed. |
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The proportion of patients experiencing ileus within 15 days after surgery, graded by the Clavien-Dindo classification system.
Unit of Measure: %
| 15 days after surgery |
| Pathology-related composite indicator | A composite indicator related to pathology, including the positive margin rate, the number of harvested lymph nodes, and the lymph node metastasis rate. These indicators will be aggregated into a single reported value through a composite score or statistical analysis. Unit of Measure: Composite score or percentage (%) | Immediate (on specimen examination, within 7 days post-op) |
| Postoperative gut microbiota diversity | The diversity of gut microbiota assessed by 16S rRNA gene sequencing at 6 months and 1 year post-surgery. The primary metrics include the Shannon diversity index and the Chao1 richness index. Unit of Measure: Shannon diversity index (dimensionless) and Chao1 richness index (number of OTUs) | 6 months and 1 year post-surgery |
| 5-year overall survival | Overall survival (OS) is defined as the time from randomization to death from any cause; survivors will be censored at the last follow-up. Unit of Measure: % | From randomization to death from any cause, assessed up to 60 months |