Single Incision Laparoscopic Colorectal Surgery

Laparoscopic Colorectal Surgery Clinical Trial

— SILCS  

Official title:

Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03151733
• Other study ID #: RJ-SILS-CRC2017
• Secondary ID: SHSDC
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 28, 2017
• Est. completion date: August 2024

Study information

• Verified date: October 2022
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Single incision laparoscopic surgery (SILS) is the further development of the concept of minimally invasive surgery for colorectal cancer,which rapidly developed in the field of colorectal surgery. Through the development of single hole laparoscopic colorectal cancer radical surgery and clinical study and follow up accordingly, evaluating the feasibility, surgical effectiveness and economy help to promote the popularization and application of single hole laparoscopic techniques in the field.

Description:

The patients with colorectal cancer will randomly divided into single incision laparoscopic surgery group and conditional laparoscopic surgery group. The operation time, blood loss, the incidence of lymph node , the number of postoperative complications, the gastrointestinal function recovery time, postoperative hospital stay，the number of local recurrence and distant metastasis, survival rate and the total cost of hospitalization will be evaluated to confirm the feasibility of single incision laparoscopic surgery is effective and economical. It is worthy of clinical application.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: August 2024
• Est. primary completion date: June 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18 years < age < 80 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 7th 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) >30 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

Related Conditions & MeSH terms

• Laparoscopic Colorectal Surgery

Intervention

Procedure:
• single incision laparoscopic surgery
Patients undergo single incision laparoscopic surgery
• conventional laparoscopic surgery
Patients undergo conventional laparoscopic surgery

Locations

Country	Name	City	State
China	ruijin hospital North	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Aldeghaither S, Zubaidi A, Alkhayal K, Al-Obaid O. Single-incision laparoscopic colorectal surgery: a report of 33 cases in Saudi Arabia. Ann Saudi Med. 2016 Jul-Aug;36(4):282-7. doi: 10.5144/0256-4947.2016.282. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early morbidity rate	morbidity rate 30 days after surgery	30 days
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