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NCT Number: NCT04201717

Intracorporeal Anastomosis Versus Extracorporeal Anastomosis for Left Colon Cancer

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the First Hospital of Jilin University, Changchun, Jilin, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age between 18 and 80 years;
  • histologically or cytologically confirmed left-sided colon cancer (distal transverse colon, left colic flexure, descending colon, or proximal sigmoid colon);
  • clinical stage T1-4a, N0-2, and M0;
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
  • suitable for laparoscopic colectomy;
  • no previous systemic chemotherapy or radiotherapy;
  • willing to provide written informed consent and comply with the research procedures.

Exclusion criteria

  • Have a history of malignant colorectal tumor or have metastatic or multiple carcinoma.
  • Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery.
  • Patients who need to undergo combined organ resection or robot-assisted colectomy.
  • Patients who are receiving preoperative neoadjuvant therapy.
  • ASA grade ≥ IV and/or ECOG performance status score > 2.
  • 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);
  • Patients with severe psychiatric illness.
  • Pregnant or lactating women.
  • Patients who have a history of taking hormonal drugs.
  • Diabetic patients whose blood sugar cannot be controlled to be within 6.1 - 8.3 mmol/L.
  • Patients with other clinical and laboratory conditions that are considered by researchers as inappropriate for participating in this trial.

Exit criteria

  • Patients with other non-tumor diseases that prevent them from continuing to receive this treatment regimen.
  • Patients who need emergency surgical resection due to intestinal obstruction, intestinal perforation, intestinal bleeding, etc. after being enrolled in the study.
  • Patients with distant metastasis confirmed by intraoperative exploration or postoperative pathology, including liver, pelvic cavity, ovary, peritoneum, distant lymph node metastasis, etc.
  • Patients who need combined organ resection as determined by intraoperative exploration.
  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. The Count of Participants With Surgical Site Infection (SSI)

    Time frame: 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 outcomes

  1. the Blood Loss

    Time frame: one hour after surgery

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

  2. the Operating Time

    Time frame: 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

  3. the Incidence of Complications

    Time frame: 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.

  4. The Rate of Conversion to Open Surgery

    Time frame: one hour after surgery

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

  5. Completeness of Specimens

    Time frame: 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.

  6. Number of Lymph Nodes Dissected

    Time frame: one week after surgery

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

  7. First Defecation Time

    Time frame: one week after surgery

    time to first defecate, measured in days.

  8. the Incision Length

    Time frame: 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.

  9. Visual Analogue Scale/Score (VAS)

    Time frame: 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.

  10. 3-year DFS (Disease-free Survival)

    Time frame: 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.

  11. 5-year OS (Overall Survival)

    Time frame: five years after the operation

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

  12. First Time for Fluid Diet

    Time frame: one week after surgery

    time to start food intake, measured in days

  13. Postoperative Hospital Stay

    Time frame: one month after surgery

    The length of hospital stay after surgery.

Sponsors and collaborators

Lead sponsor

Jilin University

Other

Registry information

Official study title

A Multicenter Randomized Clinical Trial Comparing Surgical Site Infection After Intracorporeal Anastomosis and Extracorporeal Anastomosis for Left Colon Cancer (STARS)

Important dates

Study start
2021
Primary completion
2024
Study completion
2029
First posted
Dec 17, 2019
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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