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Trial · Interventional

Active, not recruitingNot applicableResults postedRegistry data

Intracorporeal Anastomosis Versus Extracorporeal Anastomosis for Left Colon Cancer

NCTNCT04201717 (opens ClinicalTrials.gov in a new tab)Other idSTARS
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Methylene blue, does not test it. It appears in the description.

Overview

Status
Active, not recruiting
Phase
Not applicable
Enrollment
350 participants (actual)
Sponsor
Jilin University · Other
Design
Randomized · Double masking
Countries
1 country

China

Start
27 Jan 2021
Primary completion
3 Jul 2024
Completion
3 Jul 2029 (estimated)
First posted
17 Dec 2019
Last update posted
7 May 2025
Conditions
Colon Cancer

Timeline

1 trial · 1 ongoing · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20222024202620282030
  1. N/A

    Intracorporeal Anastomosis Versus Extracorporeal Anastomosis for Left Colon Cancer

    NCT04201717

    27 Jan 2021 to est. 3 Jul 2029

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • laparoscopic assisted left colectomy (extracorporeal anastomosis group)Procedure
  • total laparoscopic left colectomy (intracorporeal anastomosis group)Procedure

Arms2

  • Active comparator

    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.

  • Experimental

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · one month after surgery

    Registry description

    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(13)

  1. the Blood Loss

    Time frame · one hour after surgery

    Registry description

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

  2. the Operating Time

    Time frame · one hour after surgery

    Registry description

    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

    Registry description

    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

    Registry description

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

  5. Completeness of Specimens

    Time frame · one hour after surgery

    Registry description

    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

    Registry description

    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

    Registry description

    time to first defecate, measured in days.

  8. the Incision Length

    Time frame · one hour after surgery

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    time to start food intake, measured in days

  13. Postoperative Hospital Stay

    Time frame · one month after surgery

    Registry description

    The length of hospital stay after surgery.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· one month after surgery

The Count of Participants With Surgical Site Infection (SSI)

GroupValue (Participants)
Total Laparoscopic Left Colectomy (Intracorporeal Anastomosis Group)15
Laparoscopic Assisted Left Colectomy (Extracorporeal Anastomosis Group)20
Secondary and other outcome results(7)
Secondary outcomeMedian· one hour after surgery

the Blood Loss

GroupValue (ml)
Total Laparoscopic Left Colectomy (Intracorporeal Anastomosis Group)50
Laparoscopic Assisted Left Colectomy (Extracorporeal Anastomosis Group)50
Secondary outcome· one hour after surgery

the Operating Time

GroupValue
Secondary outcome· one month after surgery

the Incidence of Complications

GroupValue
Secondary outcome· one hour after surgery

The Rate of Conversion to Open Surgery

GroupValue
Secondary outcome· one hour after surgery

Completeness of Specimens

GroupValue
Secondary outcome· one week after surgery

Number of Lymph Nodes Dissected

GroupValue
Secondary outcome· one week after surgery

First Defecation Time

GroupValue

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
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.0 / 15710 / 15713 / 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.0 / 1596 / 15924 / 159

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedHe 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. PMID 36415000

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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