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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03633539
Other study ID # RJ-mSILSC-2018
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date August 2020
Est. completion date December 2025

Study information

Verified date September 2021
Source Ruijin Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to evaluate the short-term and long-term results after single incision laparoscopic surgery for colorectal cancer(SILSC) compared with conventional laparoscopic surgery for colorectal cancer(CLSC).


Description:

In order to improve cosmetic effect and reduce postoperative pain, single-incision laparoscopic surgery (SILS) is attracting increasing attention. SILS is considered to be the next major advance in the progress of minimally invasive surgical approaches to colorectal disease that is more feasible in generalized use. In most previous studies, SILS for colorectal cancer was feasible and short-term safe compared to conventional laparoscopic surgery (CLS) . However, there is still controversy over its potential better cosmetic effect and less postoperative pain. Moreover, the long-term oncologic outcomes are still inconclusive as only a few studies showed long-term survival data. Up to now, most studies were limited to their retrospective nature and small samples. So more studies, especially large-scale, randomized controlled trials are needed to establish the best indications for SILS for colorectal cancer.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2025
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Inclusion Criteria: - 18 years < age =85 years - Tumor located in colon and high rectum ( the lower border of the tumor is above the peritoneal reflection) - Pathological colorectal carcinoma - Clinically diagnosed cT1-4aN0-2 M0 lesions according to the 8th Edition of AJCC Cancer Staging Manual - Tumor size of 5 cm or less - ECOG score is 0-1 - ASA score is ?-? - Informed consent Exclusion Criteria: - Body mass index (BMI) >35 kg/m2 - The lower border of the tumor is located distal to the peritoneal reflection - Pregnant woman or lactating woman - Severe mental disease - Previous abdominal surgery(except appendectomy and cholecystotomy) - Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer - Requirement of simultaneous surgery for other disease

Study Design


Intervention

Procedure:
Single-incision Laparoscopic Surgery
Patients undergo single-incision laparoscopic surgery. In this group,the surgery is performed through a transumbilical port. The surgeon will adjust surgical position to expose the operative field with the help of gravity. Besides,hand over hand cross and parallel techniques are needed to achieve the SILS. All the other operative procedures are the same as conventional laparoscopic surgery.
Conventional Laparoscopic Surgery
Patients undergo conventional laparoscopic surgery. In this group,the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions.

Locations

Country Name City State
China Ruijin Hospital North Shanghai

Sponsors (4)

Lead Sponsor Collaborator
Ruijin Hospital Changhai Hospital, Fudan University, RenJi Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Song Z, Li Y, Liu K, Jiang Y, Shi Y, Ji X, Zhang T, Wu H, Shi Y, Zhao R. Clinical and oncologic outcomes of single-incision laparoscopic surgery for right colon cancer: a propensity score matching analysis. Surg Endosc. 2019 Apr;33(4):1117-1123. doi: 10.1 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative complications Postoperative complications rate 30 days after surgery 30 days after surgery
Secondary Operative time Operative time(minutes) intraoperative
Secondary Intraoperative blood loss Estimated blood loss(milliliters,ml) intraoperative
Secondary Incision length Incision length(centimeters,cm) intraoperative
Secondary Lymph node detection Lymph nodes harvested(numbers) 14 days after surgery
Secondary Incisal margin Length of proximal and distal margin (centimeters,cm) 14 days after surgery
Secondary Tumor size The diameter of tumors(centimeters,cm) 14 days after surgery
Secondary Length of stay Duration of hospital stay(days after surgery) 1-14 days after surgery
Secondary Postoperative recovery course Time to first ambulation, flatus, liquid diet and soft diet (hours after surgery) 1-14 days after surgery
Secondary Pain score Postoperative pain is recorded using the visual analog scale (VAS) pain score (0-10 points)tool on postoperative day 1, 2, 3 and the day of discharge 1-3 days after surgery
Secondary 3-year disease free survival rate 3-year disease free survival rate 36 months after surgery
Secondary 5-year overall survival rate 5-year overall survival rate 60 months after surgery
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