An interventional study of laparoscopic assisted left colectomy (extracorporeal anastomosis group) and total laparoscopic left colectomy (intracorporeal anastomosis group) in Colon Cancer, sponsored by Jilin University. Active, not recruiting at 12 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-07.
Sponsored by Jilin University · Not applicable, Interventional, and Treatment
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.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's enrollment of 350 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Jilin University is the lead sponsor of 26 studies on the registry; 12 are open to participants now.
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Exclusion criteria
Exit criteria
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.
Procedure: 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. 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.
Procedure: total laparoscopic left colectomy (intracorporeal 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.
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.
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.
Time frame: one month after surgery
the Blood Loss
It is defined as the blood loss during operation and is measured in milliliters.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: one week after surgery
First Defecation Time
time to first defecate, measured in days.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: three years after the operation
5-year OS (Overall Survival)
OS was defined as the time from randomization to death due to any cause.
Time frame: five years after the operation
First Time for Fluid Diet
time to start food intake, measured in days
Time frame: one week after surgery
Postoperative Hospital Stay
The length of hospital stay after surgery.
Time frame: one month after surgery
| Milestone | Laparoscopic Assisted Left Colectomy (Extracorporeal Anastomosis Group) | Total Laparoscopic Left Colectomy (Intracorporeal Anastomosis Group) |
|---|---|---|
| Started | 175 | 175 |
| Completed | 159 | 157 |
| Not completed | 16 | 18 |
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.
| Participants | Total Laparoscopic Left Colectomy (Intracorporeal Anastomosis Group) | Laparoscopic Assisted Left Colectomy (Extracorporeal Anastomosis Group) |
|---|---|---|
| The Count of Participants With Surgical Site Infection (SSI) | 15 | 20 |
It is defined as the blood loss during operation and is measured in milliliters.
| ml | Total Laparoscopic Left Colectomy (Intracorporeal Anastomosis Group) | Laparoscopic Assisted Left Colectomy (Extracorporeal Anastomosis Group) |
|---|---|---|
| the Blood Loss | 50 (10 to 50) | 50 (10 to 50) |
It is defined as the period from cutting the skin to suturing the skin or doing enterostomy. It is measured in minutes
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
It is defined as an abdominal incision larger than that necessary for specimen extraction.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
The number of lymph nodes in the mesentery will be calculated. Additionally, the metastatic lymph nodes will be counted.
Results for this outcome have not been posted.
time to first defecate, measured in days.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
DFS was defined as the time from randomization until the discovery of local recurrence, distant metastasis, or death from the tumor.
Results for this outcome have not been posted.
OS was defined as the time from randomization to death due to any cause.
Results for this outcome have not been posted.
time to start food intake, measured in days
Results for this outcome have not been posted.
The length of hospital stay after surgery.
Results for this outcome have not been posted.
Collected over 30 days after operation. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Total Laparoscopic Left Colectomy (Intracorporeal Anastomosis Group) | 0/157 (0%) | 10/157 (6.4%) | 13/157 (8.3%) |
| Laparoscopic Assisted Left Colectomy (Extracorporeal Anastomosis Group) | 0/159 (0%) | 6/159 (3.8%) | 24/159 (15.1%) |
| Event | Total Laparoscopic Left Colectomy (Intracorporeal Anastomosis Group) | Laparoscopic Assisted Left Colectomy (Extracorporeal Anastomosis Group) |
|---|---|---|
| Clavien-Dindo grade III or higher complicationsSurgical and medical procedures | 10/157 | 6/159 |
| Event | Total Laparoscopic Left Colectomy (Intracorporeal Anastomosis Group) | Laparoscopic Assisted Left Colectomy (Extracorporeal Anastomosis Group) |
|---|---|---|
| Clavien-Dindo graded I-II complicationsSurgical and medical procedures | 13/157 | 24/159 |
| Age, Continuous(years) | Total Laparoscopic Left Colectomy (Intracorporeal Anastomosis Group) | Laparoscopic Assisted Left Colectomy (Extracorporeal Anastomosis Group) | Total |
|---|---|---|---|
| Median | 62 (55 to 68) | 61 (53 to 69) | 61 (54 to 69) |
| Sex: Female, Male(Participants) | Total Laparoscopic Left Colectomy (Intracorporeal Anastomosis Group) | Laparoscopic Assisted Left Colectomy (Extracorporeal Anastomosis Group) | Total |
|---|---|---|---|
| Female | 45 | 52 | 97 |
| Male | 112 | 107 | 219 |
| Race/Ethnicity, Customized(Participants) | Total Laparoscopic Left Colectomy (Intracorporeal Anastomosis Group) | Laparoscopic Assisted Left Colectomy (Extracorporeal Anastomosis Group) | Total |
|---|---|---|---|
| Asian | 157 | 159 | 316 |
| bmi(kg/m^2) | Total Laparoscopic Left Colectomy (Intracorporeal Anastomosis Group) | Laparoscopic Assisted Left Colectomy (Extracorporeal Anastomosis Group) | Total |
|---|---|---|---|
| Median | 24.5 (22.1 to 26.5) | 24.8 (22.9 to 27.1) | 24.6 (22.4 to 26.6) |
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Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf, Analytic code
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