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The traditional surgical treatment for right-sided colon cancer involves the removal of an important structure, the ileocecal valve, which includes the ileocecal valve. This can lead to problems such as diarrhea and malnutrition in patients. This study reconstructs an artificial ileocecal valve through intraoperative suturing to compensate for the function of the original ileocecal valve. The control group will undergo the routine resection of the right-sided colon, including the ileocecal valve. This is a randomized controlled study. Patients enrolled will be randomly assigned to the experimental group (ileocecal valve reconstruction during surgery) or the control group (no ileocecal valve reconstruction), with no differences in other treatment procedures. After a series of follow-up observations, the research team will analyze the safety and effectiveness of the method of ileocecal valve reconstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RISE anastomosis | Experimental | After performing a conventional right hemicolectomy, an additional step is carried out in which sutures are used to artificially reconstruct an ileocecal valve structure at the ileal stump before proceeding with the ileocolic anastomosis. |
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| Control | No Intervention | Conventional right hemicolectomy was performed, with the ileocecal valve included in the resection. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RISE (Revolute Insert Side-End ileocecal valve reconstruction) | Procedure | After performing a conventional right hemicolectomy, an additional step is carried out in which sutures are used to artificially reconstruct an ileocecal valve structure at the ileal stump before proceeding with the ileocolic anastomosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first formed stool after surgery (Bristol stool score < 4). | According to the Bristol stool scale, stools are categorized into seven types. Since stool form is related to the duration of colonic transit, the scale can be used to assess intestinal transit time and evaluate anastomotic function. A score >5 is defined as diarrhea, with a score of 6 indicating mild diarrhea and a score of 7 indicating severe diarrhea. | 1 week after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Operation time | during the surgery | |
| anastomosis time | during surgery | |
| intraoperative blood loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weidong Xiao, MD | Contact | 86-13996390860 | xiaoweidong@tmmu.edu.cn | |
| Zihan Wang, Ph.D | Contact | 86-13618347369 | shakehanhanhan@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Weidong Xiao, MD | Department of General Surgery, Xinqiao Hospital, Army Medical University, No.183 Xinqiao Road, Chongqing, 400037, China | Principal Investigator |
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After the completion of this study, the data will be made public and anyone can request it by email.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 21, 2025 | Sep 1, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 9, 2025 | Sep 1, 2025 | ICF_001.pdf |
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| during surgery |
| Complications within 30 days after surgery | Surgical complications evaluation was based on the Clavien-Dindo complication scoring system. Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside. Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusionsand total parenteral nutritionare also included. Grade III Requiring surgical, endoscopic or radiological intervention Grade IV Life-threatening complication (including CNS complications)* requiring IC/ICU-management Grade V Death of a patient | 30 days after surgery |
| anastomosis healing | Colonoscopy is used to assess the healing status of an anastomosis, and to determine whether stenosis, ulcers, or other pathological changes have occurred. | 3 months, 6 months and 1 year after surgery |
| albumin level | for assessing the nutritional status. | 3 days, 1 month, 3 months, 6 months and 1 year after surgery. |
| bile acid | for assessing the nutritional status. | 3 days, 1 month, 3 months, 6 months and 1 year after surgery |
| VitB12 | for assessing the nutritional status. | 3 days, 1 month, 3 months, 6 months and 1 year after surgery |
| total protein | for assessing the nutritional status | 3 days, 1 month, 3 months, 6 months and 1 year after surgery |
| EORTCQLQ-C30 | for assessing quality of life after surgery | baseline, 1 month after surgery. |
| EORTCQLQ-CR2930 | for assessing quality of life after surgery | baseline, 1 month after surgery. |
| gut microbiota | Analyzing the changes in gut microbiota through the patient's fecal samples. | 1 month, 3 months, 6 months and 1 year after surgery. |