Intracorporeal Anastomosis Versus Extracorporeal Anastomosis for Left Colon Cancer
- Conditions
- Colon Cancer
- Interventions
- Procedure: laparoscopic assisted left colectomyProcedure: total laparoscopic left colectomy
- Registration Number
- NCT04201717
- Lead Sponsor
- Jilin University
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 350
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description laparoscopic assisted left colectomy laparoscopic assisted left colectomy 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. The patients in the control group underwent with the traditional laparoscopic assisted technology. The free colon was taken out through a small incision in the middle of the abdomen or the outer edge of the left rectus abdominis. The mesentery was trimmed, the specimens were removed, and the anastomosis was completed.After the anastomosis, the whole surgical area was flushed and drainage tubes were left. total laparoscopic left colectomy total laparoscopic left colectomy 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.In the experimental group, the mesentery was endoscopically trimmed, the specimens were excised and the anastomosis was completed under the laparoscope. The specimens were taken out through trocar incision in the navel or in the right lower abdomen. After the anastomosis, the whole surgical area was flushed and drainage tubes were left.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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.
First Defecation Time one week after surgery time to first defecate, measured in days.
Postoperative Hospital Stay one month after surgery The length of hospital stay after surgery.
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.
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.
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.
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
Trial Locations
- Locations (3)
the First Hospital of Jilin University
🇨🇳Changchun, Ji Lin, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, China
Cancer Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, China