Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer

NCT ID: NCT03633539

Last Updated: 2021-09-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-31
• Study Completion Date: 2025-12-31

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.

Conditions

Colorectal Cancer; Colonic Neoplasms; Rectal Neoplasms; Colon Disease; Colon Cancer; Rectal Cancer; Rectal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional Laparoscopic Surgery

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

Group Type: ACTIVE_COMPARATOR

Conventional Laparoscopic Surgery

Intervention Type: PROCEDURE

Patients undergo conventional laparoscopic surgery. In this group，the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions.

Single-incision Laparoscopic Surgery

Patients with colorectal cancer undergo single-incision laparoscopic surgery.

Group Type: EXPERIMENTAL

Single-incision Laparoscopic Surgery

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

SILSC; CLSC

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: collaborator

RenJi Hospital

OTHER

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Ren

Chief Physicion

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kun Liu, MD

Role: STUDY_CHAIR

Ruijin Hospitla North

Locations

Ruijin Hospital North

Shanghai, , China

Countries

China

References

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: 10.1007/s00464-018-6370-2. Epub 2018 Jul 24.

Reference Type: RESULT

PMID: 30043168 (View on PubMed)

Other Identifiers

RJ-mSILSC-2018

Identifier Type: -

Identifier Source: org_study_id