Colon Cancer
Conditions
Keywords
total laparoscopic, laparoscopic assisted, intracorporeal anastomosis, extracorporeal anastomosis
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURElaparoscopic 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.
PROCEDUREtotal 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.
Sponsors
Jilin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. age between 18 and 80 years; 2. histologically or cytologically confirmed left-sided colon cancer (distal transverse colon, left colic flexure, descending colon, or proximal sigmoid colon); 3. clinical stage T1-4a, N0-2, and M0; 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; 5. suitable for laparoscopic colectomy; 6. no previous systemic chemotherapy or radiotherapy; 7. willing to provide written informed consent and comply with the research procedures.
Exclusion criteria
1. Have a history of malignant colorectal tumor or have metastatic or multiple carcinoma. 2. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery. 3. Patients who need to undergo combined organ resection or robot-assisted colectomy. 4. Patients who are receiving preoperative neoadjuvant therapy. 5. ASA grade ≥ IV and/or ECOG performance status score \> 2. 6. Cardiopulmonary dysfunction (NYHA cardiac function classification II-IV), liver dysfunction (MELD score greater than 12), or kidney dysfunction (serum creatinine above the upper limit of normal); 7. Patients with severe psychiatric illness. 8. Pregnant or lactating women. 9. Patients who have a history of taking hormonal drugs. 10. Diabetic patients whose blood sugar cannot be controlled to be within 6.1 - 8.3 mmol/L. 11. Patients with other clinical and laboratory conditions that are considered by researchers as inappropriate for participating in this trial. Exit criteria 1. Patients with other non-tumor diseases that prevent them from continuing to receive this treatment regimen. 2. Patients who need emergency surgical resection due to intestinal obstruction, intestinal perforation, intestinal bleeding, etc. after being enrolled in the study. 3. Patients with distant metastasis confirmed by intraoperative exploration or postoperative pathology, including liver, pelvic cavity, ovary, peritoneum, distant lymph node metastasis, etc. 4. Patients who need combined organ resection as determined by intraoperative exploration. 5. Patients who request to withdraw from this study cohort for various reasons after being enrolled in the study, or who cannot complete the study plan and follow-up for various reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Count of Participants With Surgical Site Infection (SSI) | one month after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Rate of Conversion to Open Surgery | one hour after surgery | It is defined as an abdominal incision larger than that necessary for specimen extraction. |
| the Blood Loss | one hour after surgery | It is defined as the blood loss during operation and is measured in milliliters. |
| the Operating Time | one hour after surgery | It is defined as the period from cutting the skin to suturing the skin or doing enterostomy. It is measured in minutes |
| Completeness of Specimens | one hour after surgery | 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. |
| Number of Lymph Nodes Dissected | one week after surgery | The number of lymph nodes in the mesentery will be calculated. Additionally, the metastatic lymph nodes will be counted. |
| First Defecation Time | one week after surgery | time to first defecate, measured in days. |
| the Incidence of Complications | one month after surgery | 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. |
| Visual Analogue Scale/Score (VAS) | 2 days after surgery | 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. |
| 3-year DFS (Disease-free Survival) | three years after the operation | DFS was defined as the time from randomization until the discovery of local recurrence, distant metastasis, or death from the tumor. |
| 5-year OS (Overall Survival) | five years after the operation | OS was defined as the time from randomization to death due to any cause. |
| First Time for Fluid Diet | one week after surgery | time to start food intake, measured in days |
| Postoperative Hospital Stay | one month after surgery | The length of hospital stay after surgery. |
| the Incision Length | one hour after surgery | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 157 |
| 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. | 159 |
| Total | 316 |
Baseline characteristics
| Characteristic | Total Laparoscopic Left Colectomy (Intracorporeal Anastomosis Group) | Laparoscopic Assisted Left Colectomy (Extracorporeal Anastomosis Group) | Total |
|---|---|---|---|
| Age, Continuous | 62 years | 61 years | 61 years |
| bmi | 24.5 kg/m^2 | 24.8 kg/m^2 | 24.6 kg/m^2 |
| Race/Ethnicity, Customized Asian | 157 Participants | 159 Participants | 316 Participants |
| Sex: Female, Male Female | 45 Participants | 52 Participants | 97 Participants |
| Sex: Female, Male Male | 112 Participants | 107 Participants | 219 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 157 | 0 / 159 |
| other Total, other adverse events | 13 / 157 | 24 / 159 |
| serious Total, serious adverse events | 10 / 157 | 6 / 159 |
Outcome results
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.
Time frame: one month after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Laparoscopic Left Colectomy (Intracorporeal Anastomosis Group) | The Count of Participants With Surgical Site Infection (SSI) | 15 Participants |
| Laparoscopic Assisted Left Colectomy (Extracorporeal Anastomosis Group) | The Count of Participants With Surgical Site Infection (SSI) | 20 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.
Time frame: three years after the operation
Secondary
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
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.
Time frame: one hour after surgery
Secondary
First Defecation Time
time to first defecate, measured in days.
Time frame: one week after surgery
Secondary
First Time for Fluid Diet
time to start food intake, measured in days
Time frame: one week after surgery
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.
Time frame: one week after surgery
Secondary
Postoperative Hospital Stay
The length of hospital stay after surgery.
Time frame: one month after surgery
Secondary
the Blood Loss
It is defined as the blood loss during operation and is measured in milliliters.
Time frame: one hour after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Total Laparoscopic Left Colectomy (Intracorporeal Anastomosis Group) | the Blood Loss | 50 ml |
| Laparoscopic Assisted Left Colectomy (Extracorporeal Anastomosis Group) | the Blood Loss | 50 ml |
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.
Time frame: one month after surgery
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.
Time frame: 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
Time frame: one hour after surgery
Secondary
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
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.
Time frame: 2 days after surgery