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Single Incision Laparoscopic Colorectal Surgery

NCT ID: NCT03151733

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-28

Study Completion Date

2024-06-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Laparoscopic Colorectal Surgery

Keywords

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SILS colorectal cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single incision laparoscopic surgery

patients with colorectal cancer and undergo single incision laparoscopic surgery

Group Type EXPERIMENTAL

single incision laparoscopic surgery

Intervention Type PROCEDURE

Patients undergo single incision laparoscopic surgery

Conventional laparoscopic surgery

patients with colorectal cancer and undergo conventional laparoscopic surgery

Group Type PLACEBO_COMPARATOR

conventional laparoscopic surgery

Intervention Type PROCEDURE

Patients undergo conventional laparoscopic surgery

Interventions

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single incision laparoscopic surgery

Patients undergo single incision laparoscopic surgery

Intervention Type PROCEDURE

conventional laparoscopic surgery

Patients undergo conventional laparoscopic surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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 Ⅰ-Ⅲ
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhao Ren

chief physicion

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liu Kun, MD

Role: STUDY_CHAIR

ruijin hospitla North

Locations

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ruijin hospital North

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 27478914 (View on PubMed)

Song Z, Liu K, Li Y, Shi Y, Jiang Y, Wang C, Chen X, Zhang T, Ji X, Zhao R. Short-Term Outcomes of Single-Incision Laparoscopic Surgery for Colorectal Cancer: A Single-Center, Open-Label, Non-Inferiority, Randomized Clinical Trial. Front Oncol. 2021 Oct 25;11:762147. doi: 10.3389/fonc.2021.762147. eCollection 2021.

Reference Type DERIVED
PMID: 34760706 (View on PubMed)

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 DERIVED
PMID: 30043168 (View on PubMed)

Other Identifiers

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SHSDC

Identifier Type: OTHER

Identifier Source: secondary_id

RJ-SILS-CRC2017

Identifier Type: -

Identifier Source: org_study_id