Intracorporeal Anastomosis Versus Extracorporeal Anastomosis for Left Colon Cancer

NCT ID: NCT04201717

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-27
• Study Completion Date: 2029-07-03

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.

Conditions

Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

laparoscopic assisted left colectomy (extracorporeal anastomosis group)

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

total laparoscopic left colectomy (intracorporeal anastomosis group)

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Dong Yang

Assisted Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Quan Wang, doctor

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Locations

the First Hospital of Jilin University

Changchun, Jilin, China

Beijing Friendship Hospital, Capital Medical University

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

Countries

China

References

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.

Reference Type: DERIVED

PMID: 36415000 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STARS

Identifier Type: -

Identifier Source: org_study_id