NCT04527861

Oncologic Outcomes of Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer

Oncologic Outcomes of Single-incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer: A Multi-center, Prospective, Open Label, Non-inferiority, Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 710 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to investigate long-term oncologic outcomes of single-incision laparoscopic surgery (SILS) compared to conventional laparoscopic surgery (CLS) for colorectal cancer.

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.

Conditions

• Colorectal Cancer
• Colon Cancer
• Rectal Cancer

Interventions

Type	Name	Description
PROCEDURE	Single-incision Laparoscopic Surgery	In this group，the surgery is performed through a single incision. 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.
PROCEDURE	Conventional Laparoscopic Surgery	In this group，the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions.

Timeline

• Start date: 2021-04-08
• Primary completion: 2024-04-01
• Completion: 2029-04-01
• First posted: 2020-08-27
• Last updated: 2022-10-10

Locations

11 sites across 1 country: China