mSILSC: Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer

Sponsor

Ruijin Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03633539

Collaborator

Changhai Hospital (Other), Fudan University (Other), RenJi Hospital (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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）.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Colonic Neoplasms Rectal Neoplasms Colon Disease Colon Cancer Rectal Cancer Rectal Diseases	Procedure: Single-incision Laparoscopic Surgery Procedure: Conventional Laparoscopic Surgery	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Multi-center Prospective Randomized Controlled Study of the Single-incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer

Anticipated Study Start Date :

Aug 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional Laparoscopic Surgery Patients with colorectal cancer undergo conventional laparoscopic surgery（multi-ports）.	Procedure: 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. Other Names: CLSC
Experimental: Single-incision Laparoscopic Surgery Patients with colorectal cancer undergo single-incision laparoscopic surgery.	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. Other Names: SILSC

Arm

Intervention/Treatment

Active Comparator: Conventional Laparoscopic Surgery

Patients with colorectal cancer undergo conventional laparoscopic surgery（multi-ports）.

Procedure: 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.

Other Names:

CLSC

Experimental: Single-incision Laparoscopic Surgery

Patients with colorectal cancer undergo single-incision laparoscopic surgery.

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.

Other Names:

SILSC

Outcome Measures

Primary Outcome Measures

Postoperative complications [30 days after surgery]
Postoperative complications rate 30 days after surgery

Secondary Outcome Measures

Operative time [intraoperative]
Operative time（minutes）
Intraoperative blood loss [intraoperative]
Estimated blood loss（milliliters，ml）
Incision length [intraoperative]
Incision length（centimeters，cm）
Lymph node detection [14 days after surgery]
Lymph nodes harvested（numbers）
Incisal margin [14 days after surgery]
Length of proximal and distal margin （centimeters，cm）
Tumor size [14 days after surgery]
The diameter of tumors（centimeters，cm）
Length of stay [1-14 days after surgery]
Duration of hospital stay（days after surgery）
Postoperative recovery course [1-14 days after surgery]
Time to first ambulation, flatus, liquid diet and soft diet （hours after surgery）
Pain score [1-3 days after surgery]
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
3-year disease free survival rate [36 months after surgery]
3-year disease free survival rate
5-year overall survival rate [60 months after surgery]
5-year overall survival rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 Ⅰ-Ⅲ
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