CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 350 enrolled
Drug / intervention
laparoscopic assisted left colectomy (extracorporeal anastomosis group) +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04201717
NCT04201717N/AActive

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

Jilin University·interventional·Posted Dec 17, 2019·Updated May 7, 2025

In Brief

A clinical study evaluating laparoscopic assisted left colectomy (extracorporeal anastomosis group) and total laparoscopic left colectomy (intracorporeal anastomosis group) for Colon Cancer. Active but no longer recruiting, targeting 350 participants across 12 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColon Cancer
CountriesChina
Collaborators--

Timeline

N/AActive
2020202120222023202420252026202720282029
First PostedDec 17, 2019
Enrollment StartJan 27, 2021
Primary CompletionJul 3, 2024
Study CompletionJul 3, 2029
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 6.5 years ago

Interventions

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.