Trial Outcomes & Findings for Intracorporeal Anastomosis Versus Extracorporeal Anastomosis for Left Colon Cancer (NCT NCT04201717)

NCT ID: NCT04201717

Last Updated: 2025-05-07

Results Overview

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.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 350 participants
• Primary outcome timeframe: one month after surgery
• Results posted on: 2025-05-07

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	175	175
Overall Study COMPLETED	159	157
Overall Study NOT COMPLETED	16	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intracorporeal Anastomosis Versus Extracorporeal Anastomosis for Left Colon Cancer

Baseline characteristics by cohort

Measure	Total Laparoscopic Left Colectomy (Intracorporeal Anastomosis Group) n=157 Participants 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.	Laparoscopic Assisted Left Colectomy (Extracorporeal Anastomosis Group) n=159 Participants 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.	Total n=316 Participants Total of all reporting groups
Age, Continuous	62 years n=93 Participants	61 years n=4 Participants	61 years n=27 Participants
Sex: Female, Male Female	45 Participants n=93 Participants	52 Participants n=4 Participants	97 Participants n=27 Participants
Sex: Female, Male Male	112 Participants n=93 Participants	107 Participants n=4 Participants	219 Participants n=27 Participants
Race/Ethnicity, Customized Asian	157 Participants n=93 Participants	159 Participants n=4 Participants	316 Participants n=27 Participants
bmi	24.5 kg/m^2 n=93 Participants	24.8 kg/m^2 n=4 Participants	24.6 kg/m^2 n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Total Laparoscopic Left Colectomy (Intracorporeal Anastomosis Group) n=157 Participants 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.	Laparoscopic Assisted Left Colectomy (Extracorporeal Anastomosis Group) n=159 Participants 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.
The Count of Participants With Surgical Site Infection (SSI)	15 Participants	20 Participants

SECONDARY outcome

Timeframe: one hour after surgery

It is defined as the blood loss during operation and is measured in milliliters.

Outcome measures

Measure	Total Laparoscopic Left Colectomy (Intracorporeal Anastomosis Group) n=151 Participants 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.	Laparoscopic Assisted Left Colectomy (Extracorporeal Anastomosis Group) n=154 Participants 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.
the Blood Loss	50 ml Interval 10.0 to 50.0	50 ml Interval 10.0 to 50.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one hour after surgery

It is defined as an abdominal incision larger than that necessary for specimen extraction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one week after surgery

The number of lymph nodes in the mesentery will be calculated. Additionally, the metastatic lymph nodes will be counted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one week after surgery

time to first defecate, measured in days.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: five years after the operation

OS was defined as the time from randomization to death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one week after surgery

time to start food intake, measured in days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one month after surgery

The length of hospital stay after surgery.

Outcome measures

Outcome data not reported

Adverse Events

Total Laparoscopic Left Colectomy (Intracorporeal Anastomosis Group)

Serious events: 10 serious events

Other events: 13 other events

Deaths: 0 deaths

Laparoscopic Assisted Left Colectomy (Extracorporeal Anastomosis Group)

Serious events: 6 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	Total Laparoscopic Left Colectomy (Intracorporeal Anastomosis Group) n=157 participants at risk 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.	Laparoscopic Assisted Left Colectomy (Extracorporeal Anastomosis Group) n=159 participants at risk 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.
Surgical and medical procedures Clavien-Dindo grade III or higher complications	6.4% 10/157 • Number of events 10 • 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).	3.8% 6/159 • Number of events 6 • 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).

Other adverse events

Measure	Total Laparoscopic Left Colectomy (Intracorporeal Anastomosis Group) n=157 participants at risk 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.	Laparoscopic Assisted Left Colectomy (Extracorporeal Anastomosis Group) n=159 participants at risk 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.
Surgical and medical procedures Clavien-Dindo graded I-II complications	8.3% 13/157 • Number of events 13 • 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).	15.1% 24/159 • Number of events 24 • 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).

Additional Information

Dr. Quan Wang

FIrst Hospital of Jilin University

Phone: +86 ‭15843073207‬

Email: wquan@jlu.edu.cn

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place