Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer

Not Applicable

Withdrawn

• Conditions: Rectal Neoplasms; Colon Cancer; Colorectal Cancer; Colonic Neoplasms; Rectal Diseases; Colon Disease; Rectal Cancer
• Interventions: Procedure: Single-incision Laparoscopic Surgery; Procedure: Conventional Laparoscopic Surgery

• Registration Number: NCT03633539
• Lead Sponsor: Ruijin Hospital

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）.

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 Timeline

• Study First Submitted: 2018-08-14
• Study First Submitted QC: 2018-08-14
• Study First Posted: 2018-08-16
• Study Start: 2020-08
• Primary Completion: 2020-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-10
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-incision Laparoscopic Surgery	Single-incision Laparoscopic Surgery	Patients with colorectal cancer undergo single-incision laparoscopic surgery.
Conventional Laparoscopic Surgery	Conventional Laparoscopic Surgery	Patients with colorectal cancer undergo conventional laparoscopic surgery（multi-ports）.

Primary Outcome Measures

Name	Time	Method
Postoperative complications	30 days after surgery	Postoperative complications rate 30 days after surgery

Secondary Outcome Measures

Name	Time	Method
Operative time	intraoperative	Operative time（minutes）
Intraoperative blood loss	intraoperative	Estimated blood loss（milliliters，ml）
Incision length	intraoperative	Incision length（centimeters，cm）
Length of stay	1-14 days after surgery	Duration of hospital stay（days 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
Lymph node detection	14 days after surgery	Lymph nodes harvested（numbers）
5-year overall survival rate	60 months after surgery	5-year overall survival rate
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）
Postoperative recovery course	1-14 days after surgery	Time to first ambulation, flatus, liquid diet and soft diet （hours after surgery）

Trial Locations

Locations (1)

Ruijin Hospital North; 🇨🇳 Shanghai, China