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This study aims to investigate the effects of intracorporeal anastomosis and extracorporeal anastomosis in laparoscopic-assisted radical left hemicolectomy on surgical site infection. Also consider perioperative recovery, safety, and oncology outcomes.
This is a prospective, randomized controlled trial. In this trial, cases in the intracorporeal anastomosis group and the extracorporeal anastomosis group are allocated at a 1:1 ratio among patients undergoing laparoscopic radical left hemicolectomy. The peri-operative recovery data, complications, oncology outcomes, and survival are compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laparoscopic assisted left colectomy (extracorporeal anastomosis group) | Active Comparator | All patients underwent laparoscopic dissection according to the left hemicolon cancer resection standard. lymph nodes and blood vessels, are completely trimmed and resected in an en bloc fashion. A small incision is made in the middle of the abdomen to trim the mesentery, remove the specimen, and complete the anastomosis. After completing the anastomosis, the incision will be sutured. |
|
| total laparoscopic left colectomy (intracorporeal anastomosis group) | Experimental | All patients underwent laparoscopic dissection according to the left hemicolon cancer resection standard. lymph nodes and blood vessels, are completely trimmed and resected in an en bloc fashion. Mesentery resection is performed under laparoscopy, and anastomosis is completed under laparoscopy. A small incision is made to extract the specimen after the anastomosis is completed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic assisted left colectomy (extracorporeal anastomosis group) | Procedure | For patients in the control group, the surgeon uses wound edge protectors to exteriorize the colon through a small incision in the midline of the abdomen. A ruler and methylene blue solution are employed to mark the area for colon resection. This guarantees a 10-cm margin from the tumor. Guided by these markers, the marginal vessels and mesentery are divided outside the body. The method of anastomosis is at the surgeon's discretion. A side-to-side anastomosis (including antiperistaltic, isoperistaltic, or overlapping anastomosis) is recommended. Side-to-end or end-to-end anastomosis (sewn by hand or by inserting a circular stapler through the anus or proximal colon) is also allowed. After completing the anastomosis, the incision is sutured. An abdominal drainage tube is inserted at the end of the operation. |
| Measure | Description | Time Frame |
|---|---|---|
| The Count of Participants With Surgical Site Infection (SSI) | The primary outcome was the incidence of SSI based on the Definitions of CDC guidelines: superficial incisional, deep incisional, and organ/space infections . Infections involving both organ/space and the incisional site (superficial or deep) were categorized as organ/space infections. Surgeons and nurses assessed the presence of infection daily during hospitalization. After hospital discharge, all patients were followed up until 30 days after surgery at outpatient clinics to check the wound. | one month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| the Blood Loss | It is defined as the blood loss during operation and is measured in milliliters. | one hour after surgery |
| the Operating Time | It is defined as the period from cutting the skin to suturing the skin or doing enterostomy. It is measured in minutes |
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Inclusion criteria
Exclusion criteria
Exit criteria
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| Name | Affiliation | Role |
|---|---|---|
| Quan Wang, doctor | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Hospital of Jilin University | Changchun | Jilin | 130021 | China | ||
| Beijing Friendship Hospital, Capital Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36415000 | Derived | He L, Li M, Zhang JX, Tong WH, Chen Y, Wang Q. Surgical site infection after intracorporeal anastomosis for left-sided colon cancer: study protocol for a non-inferiority multicenter randomized controlled trial (STARS). Trials. 2022 Nov 22;23(1):954. doi: 10.1186/s13063-022-06914-5. |
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If other researchers want to get the individual participant data of this study and have proper reasons, we'll share the data after the study is completed. Researchers can send an email to the Principal Investigator to ask for permission to use the data.
The Study Protocol, SAP (Statistical Analysis Plan), ICF (Informed Consent Form), and analytic code will be made available following the publication of the primary outcomes. The Individual Participant Data (IPD) will be accessible after the publication of all the long-term secondary outcomes.
Researchers can send an email to the Principal Investigator to apply for the right to use the data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Laparoscopic Assisted Left Colectomy (Extracorporeal Anastomosis Group) | All patients underwent laparoscopic dissection according to the left hemicolon cancer resection standard. lymph nodes and blood vessels, are completely trimmed and resected in an en bloc fashion. A small incision is made in the middle of the abdomen to trim the mesentery, remove the specimen, and complete the anastomosis. After completing the anastomosis, the incision will be sutured. laparoscopic assisted left colectomy (extracorporeal anastomosis group): For patients in the control group, the surgeon uses wound edge protectors to exteriorize the colon through a small incision in the midline of the abdomen. A ruler and methylene blue solution are employed to mark the area for colon resection. This guarantees a 10-cm margin from the tumor. Guided by these markers, the marginal vessels and mesentery are divided outside the body. The method of anastomosis is at the surgeon's discretion. A side-to-side anastomosis (including antiperistaltic, isoperistaltic, or overlapping anastomosis) is recommended. Side-to-end or end-to-end anastomosis (sewn by hand or by inserting a circular stapler through the anus or proximal colon) is also allowed. After completing the anastomosis, the incision is sutured. An abdominal drainage tube is inserted at the end of the operation. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 5, 2023 |
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The clinical surgeons, outcome assessors, data recorders, and statisticians will all operate independently. Due to the nature of the surgical interventions, the surgeons will not be blinded to treatment allocation. However, the outcomes assessor who assess or analyze the end point will be blinded. The patients will also be blinded to group allocation to reduce the risk of bias. Unblinding will not be performed unless the finalization of the main data analysis or required for patient's safety. After the data analysis, we will have a blinded interpretation of the study results to minimize misleading data interpretation.
|
| total laparoscopic left colectomy (intracorporeal anastomosis group) | Procedure | In the experimental group, the surgeon will use a 10-cm medical suture and methylene blue solution to mark the resection margin. The marginal vessels and mesentery will be divided inside the body. The proximal and distal colons are resected using a 60mm linear laparoscopic stapler. Side-to-side intracorporeal anastomotic techniques like anti-peristaltic, iso-peristaltic, or overlap methods will be applied. Once the anastomosis is completed, the specimen is retrieved. The surgeon can place the specimen in a sterile plastic bag for retrieval. Alternatively, the surgeon can use a disposable incision retraction fixator to protect the wound. An abdominal drainage tube is inserted. |
|
| one hour after surgery |
| the Incidence of Complications | It includes fever of unknown origin, bowel obstruction, anastomotic leakage, SSI, other incisional complications, respiratory complications, urinary complications, cardiovascular and cerebrovascular complications, diarrhea, chylous fistula, intraperitoneal hemorrhage, digestive hemorrhage, gastroparesis, and others (including bacteremia, cholecystitis, ion discharge, pancreatitis, and mental and behavioral abnormalities). Complications are graded according to the Clavien-Dindo classification. | one month after surgery |
| The Rate of Conversion to Open Surgery | It is defined as an abdominal incision larger than that necessary for specimen extraction. | one hour after surgery |
| Completeness of Specimens | It is evaluated according to the West classification. The resected specimens will be classified into three groups according to the plane of dissection: mesocolic plane, intramesocolic plane, and muscularis propria plane. | one hour after surgery |
| Number of Lymph Nodes Dissected | The number of lymph nodes in the mesentery will be calculated. Additionally, the metastatic lymph nodes will be counted. | one week after surgery |
| First Defecation Time | time to first defecate, measured in days. | one week after surgery |
| the Incision Length | The incision length is measured with an aseptic ruler at the end of the surgery, after the incision is sutured. It is measured in millimeters. | one hour after surgery |
| Visual Analogue Scale/Score (VAS) | Pain severity was assessed 48 hours after the operation using a ruler about 10 cm long. The ruler is numbered from 0 to 10. 0-3 points indicate no to mild pain. 4-6 points represent moderate pain. 7-10 points stand for severe pain. | 2 days after surgery |
| 3-year DFS (Disease-free Survival) | DFS was defined as the time from randomization until the discovery of local recurrence, distant metastasis, or death from the tumor. | three years after the operation |
| 5-year OS (Overall Survival) | OS was defined as the time from randomization to death due to any cause. | five years after the operation |
| First Time for Fluid Diet | time to start food intake, measured in days | one week after surgery |
| Postoperative Hospital Stay | The length of hospital stay after surgery. | one month after surgery |
| Beijing |
| China |
| Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | China |
| Chinese People's Liberation Army General Hospital | Beijing | China |
| Peking Union Medical College Hospital | Beijing | China |
| Peking University Cancer Hospital | Beijing | China |
| The Third Hospital of Jilin University (China - Japan Union Hospital of Jilin University) | Changchun | China |
| Daping Hospital of Army Medical University | Chongqing | China |
| Nanfang Hospital of Southern Medical University | Guangzhou | China |
| Fudan University Shanghai Cancer Center (Cancer Hospital Affiliated to Fudan University) | Shanghai | China |
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University | Shanghai | China |
| Shengjing Hospital Affiliated to China Medical University | Shenyang | China |
| FG001 | Total Laparoscopic Left Colectomy (Intracorporeal Anastomosis Group) | All patients underwent laparoscopic dissection according to the left hemicolon cancer resection standard. lymph nodes and blood vessels, are completely trimmed and resected in an en bloc fashion. Mesentery resection is performed under laparoscopy, and anastomosis is completed under laparoscopy. A small incision is made to extract the specimen after the anastomosis is completed. total laparoscopic left colectomy (intracorporeal anastomosis group): In the experimental group, the surgeon will use a 10-cm medical suture and methylene blue solution to mark the resection margin. The marginal vessels and mesentery will be divided inside the body. The proximal and distal colons are resected using a 60mm linear laparoscopic stapler. Side-to-side intracorporeal anastomotic techniques like anti-peristaltic, iso-peristaltic, or overlap methods will be applied. Once the anastomosis is completed, the specimen is retrieved. The surgeon can place the specimen in a sterile plastic bag for retrieval. Alternatively, the surgeon can use a disposable incision retraction fixator to protect the wound. An abdominal drainage tube is inserted. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Laparoscopic Left Colectomy (Intracorporeal Anastomosis Group) | All patients underwent laparoscopic dissection according to the left hemicolon cancer resection standard. lymph nodes and blood vessels, are completely trimmed and resected in an en bloc fashion. Mesentery resection is performed under laparoscopy, and anastomosis is completed under laparoscopy. A small incision is made to extract the specimen after the anastomosis is completed. total laparoscopic left colectomy (intracorporeal anastomosis group): In the experimental group, the surgeon will use a 10-cm medical suture and methylene blue solution to mark the resection margin. The marginal vessels and mesentery will be divided inside the body. The proximal and distal colons are resected using a 60mm linear laparoscopic stapler. Side-to-side intracorporeal anastomotic techniques like anti-peristaltic, iso-peristaltic, or overlap methods will be applied. Once the anastomosis is completed, the specimen is retrieved. The surgeon can place the specimen in a sterile plastic bag for retrieval. Alternatively, the surgeon can use a disposable incision retraction fixator to protect the wound. An abdominal drainage tube is inserted. |
| BG001 | Laparoscopic Assisted Left Colectomy (Extracorporeal Anastomosis Group) | All patients underwent laparoscopic dissection according to the left hemicolon cancer resection standard. lymph nodes and blood vessels, are completely trimmed and resected in an en bloc fashion. A small incision is made in the middle of the abdomen to trim the mesentery, remove the specimen, and complete the anastomosis. After completing the anastomosis, the incision will be sutured. laparoscopic assisted left colectomy (extracorporeal anastomosis group): For patients in the control group, the surgeon uses wound edge protectors to exteriorize the colon through a small incision in the midline of the abdomen. A ruler and methylene blue solution are employed to mark the area for colon resection. This guarantees a 10-cm margin from the tumor. Guided by these markers, the marginal vessels and mesentery are divided outside the body. The method of anastomosis is at the surgeon's discretion. A side-to-side anastomosis (including antiperistaltic, isoperistaltic, or overlapping anastomosis) is recommended. Side-to-end or end-to-end anastomosis (sewn by hand or by inserting a circular stapler through the anus or proximal colon) is also allowed. After completing the anastomosis, the incision is sutured. An abdominal drainage tube is inserted at the end of the operation. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| bmi | Median | Inter-Quartile Range | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Count of Participants With Surgical Site Infection (SSI) | The primary outcome was the incidence of SSI based on the Definitions of CDC guidelines: superficial incisional, deep incisional, and organ/space infections . Infections involving both organ/space and the incisional site (superficial or deep) were categorized as organ/space infections. Surgeons and nurses assessed the presence of infection daily during hospitalization. After hospital discharge, all patients were followed up until 30 days after surgery at outpatient clinics to check the wound. | Posted | Count of Participants | Participants | one month after surgery |
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| Secondary | the Blood Loss | It is defined as the blood loss during operation and is measured in milliliters. | Posted | Median | Inter-Quartile Range | ml | one hour after surgery |
| |||||||||||||||||||||||||||||||
| Secondary | the Operating Time | It is defined as the period from cutting the skin to suturing the skin or doing enterostomy. It is measured in minutes | Not Posted | one hour after surgery | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | the Incidence of Complications | It includes fever of unknown origin, bowel obstruction, anastomotic leakage, SSI, other incisional complications, respiratory complications, urinary complications, cardiovascular and cerebrovascular complications, diarrhea, chylous fistula, intraperitoneal hemorrhage, digestive hemorrhage, gastroparesis, and others (including bacteremia, cholecystitis, ion discharge, pancreatitis, and mental and behavioral abnormalities). Complications are graded according to the Clavien-Dindo classification. | Not Posted | one month after surgery | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | The Rate of Conversion to Open Surgery | It is defined as an abdominal incision larger than that necessary for specimen extraction. | Not Posted | one hour after surgery | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Completeness of Specimens | It is evaluated according to the West classification. The resected specimens will be classified into three groups according to the plane of dissection: mesocolic plane, intramesocolic plane, and muscularis propria plane. | Not Posted | one hour after surgery | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Number of Lymph Nodes Dissected | The number of lymph nodes in the mesentery will be calculated. Additionally, the metastatic lymph nodes will be counted. | Not Posted | one week after surgery | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | First Defecation Time | time to first defecate, measured in days. | Not Posted | one week after surgery | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | the Incision Length | The incision length is measured with an aseptic ruler at the end of the surgery, after the incision is sutured. It is measured in millimeters. | Not Posted | one hour after surgery | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Visual Analogue Scale/Score (VAS) | Pain severity was assessed 48 hours after the operation using a ruler about 10 cm long. The ruler is numbered from 0 to 10. 0-3 points indicate no to mild pain. 4-6 points represent moderate pain. 7-10 points stand for severe pain. | Not Posted | 2 days after surgery | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | 3-year DFS (Disease-free Survival) | DFS was defined as the time from randomization until the discovery of local recurrence, distant metastasis, or death from the tumor. | Not Posted | three years after the operation | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | 5-year OS (Overall Survival) | OS was defined as the time from randomization to death due to any cause. | Not Posted | five years after the operation | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | First Time for Fluid Diet | time to start food intake, measured in days | Not Posted | one week after surgery | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Postoperative Hospital Stay | The length of hospital stay after surgery. | Not Posted | one month after surgery | Participants |
30 days after operation
Adverse events studied include intraoperative secondary injuries in patients and serious complications and deaths within 30 days after surgery. An adverse event is defined as any adverse experience that occurs in the subject during the study, regardless of whether it's considered associated with total laparoscopic anastomosis. These include: 1) Accidental secondary damage during surgery. 2) Serious complications after surgery (grade III and above).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Total Laparoscopic Left Colectomy (Intracorporeal Anastomosis Group) | All patients underwent laparoscopic dissection according to the left hemicolon cancer resection standard. lymph nodes and blood vessels, are completely trimmed and resected in an en bloc fashion. Mesentery resection is performed under laparoscopy, and anastomosis is completed under laparoscopy. A small incision is made to extract the specimen after the anastomosis is completed. total laparoscopic left colectomy (intracorporeal anastomosis group): In the experimental group, the surgeon will use a 10-cm medical suture and methylene blue solution to mark the resection margin. The marginal vessels and mesentery will be divided inside the body. The proximal and distal colons are resected using a 60mm linear laparoscopic stapler. Side-to-side intracorporeal anastomotic techniques like anti-peristaltic, iso-peristaltic, or overlap methods will be applied. Once the anastomosis is completed, the specimen is retrieved. The surgeon can place the specimen in a sterile plastic bag for retrieval. Alternatively, the surgeon can use a disposable incision retraction fixator to protect the wound. An abdominal drainage tube is inserted. | 0 | 157 | 10 | 157 | 13 | 157 |
| EG001 | Laparoscopic Assisted Left Colectomy (Extracorporeal Anastomosis Group) | All patients underwent laparoscopic dissection according to the left hemicolon cancer resection standard. lymph nodes and blood vessels, are completely trimmed and resected in an en bloc fashion. A small incision is made in the middle of the abdomen to trim the mesentery, remove the specimen, and complete the anastomosis. After completing the anastomosis, the incision will be sutured. laparoscopic assisted left colectomy (extracorporeal anastomosis group): For patients in the control group, the surgeon uses wound edge protectors to exteriorize the colon through a small incision in the midline of the abdomen. A ruler and methylene blue solution are employed to mark the area for colon resection. This guarantees a 10-cm margin from the tumor. Guided by these markers, the marginal vessels and mesentery are divided outside the body. The method of anastomosis is at the surgeon's discretion. A side-to-side anastomosis (including antiperistaltic, isoperistaltic, or overlapping anastomosis) is recommended. Side-to-end or end-to-end anastomosis (sewn by hand or by inserting a circular stapler through the anus or proximal colon) is also allowed. After completing the anastomosis, the incision is sutured. An abdominal drainage tube is inserted at the end of the operation. | 0 | 159 | 6 | 159 | 24 | 159 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clavien-Dindo grade III or higher complications | Surgical and medical procedures | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clavien-Dindo graded I-II complications | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Quan Wang | FIrst Hospital of Jilin University | +86 15843073207 | wquan@jlu.edu.cn |
| Apr 20, 2025 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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