NCT02117557

Brief Summary

  • Compared with traditional open colectomy, laparoscopic surgery is associated with less pain, earlier recovery, and better cosmetic outcome, and its short- and long-term oncologic outcomes have been demonstrated.
  • In experienced surgeons' hands, single incision laparoscopic surgery is increasingly performed for colorectal disease, and even for malignant lesion because of its reduced incision-associated morbidity and scarring.
  • However, the safety and efficacy of single incision laparoscopic surgery for colorectal cancer has not yet been evaluated. Thus, the prospective randomized trial comparing single incision versus conventional laparoscopic surgery for colorectal cancer is needed.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
198

participants targeted

Target at P75+ for phase_2 colorectal-cancer

Timeline
Completed

Started Apr 2014

Longer than P75 for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

April 21, 2014

Status Verified

April 1, 2014

Enrollment Period

3 years

First QC Date

April 16, 2014

Last Update Submit

April 17, 2014

Conditions

Colorectal Cancer

Keywords

Single-incisionLaparoscopyColorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Early morbidity rate

    The early morbidity rate is defined as the event observed during operation and within 30 days after surgery,

    30 days

Secondary Outcomes (8)

  • Operative outcomes

    intraoperative

  • Pathological outecomes

    5 days

  • Postoperative recovery course

    14 days

  • Pain score

    14 days

  • Cosmetic assessment

    14 days

  • +3 more secondary outcomes

Study Arms (2)

Single incision laparoscopic surgery

EXPERIMENTAL

Transumbilical single incision laparoscopic surgery will be performed for patients in this group.And addition of only one trocar through the stoma for drainage tube is allowed.

Procedure: Single incision laparoscopic surgery

Conventional laparoscopic surgery

ACTIVE COMPARATOR

Conventional laparoscopic surgery for colorectal cancer will be performed for patients in this group.

Procedure: Conventional laparoscopic surgery

Interventions

Single incision laparoscopic surgeryPROCEDURE
Also known as: SILS
Single incision laparoscopic surgery
Conventional laparoscopic surgeryPROCEDURE
Also known as: CLS
Conventional laparoscopic surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years \< age \< 80 years
  • Tumor located in rectosigmoid (defined as 10- to 30-cm from the anal verge)
  • Pathological rectosigmoid carcinoma
  • Preoperative T stage ranging from T1 to T4a according to the 7th Edition of AJCC Cancer Staging Manual
  • Tumor size of 5 cm or less; 6) ECOG score is 0-1
  • ASA socre is Ⅰ-Ⅲ
  • Informed consent

You may not qualify if:

  • Body mass index (BMI) \>30 kg/m2
  • Pregnant woman or lactating woman
  • Severe mental disease
  • Previous abdominal surgery
  • Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
  • Requirement of simultaneous surgery for other disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510-515, China

RECRUITING

Related Publications (7)

  • Bucher P, Pugin F, Morel P. Single-port access laparoscopic radical left colectomy in humans. Dis Colon Rectum. 2009 Oct;52(10):1797-801. doi: 10.1007/DCR.0b013e3181b551ce.

    PMID: 19966617BACKGROUND

  • Gash KJ, Goede AC, Chambers W, Greenslade GL, Dixon AR. Laparoendoscopic single-site surgery is feasible in complex colorectal resections and could enable day case colectomy. Surg Endosc. 2011 Mar;25(3):835-40. doi: 10.1007/s00464-010-1275-8. Epub 2010 Aug 24.

    PMID: 20734083BACKGROUND

  • Lim SW, Kim HJ, Kim CH, Huh JW, Kim YJ, Kim HR. Umbilical incision laparoscopic colectomy with one additional port for colorectal cancer. Tech Coloproctol. 2013 Apr;17(2):193-9. doi: 10.1007/s10151-012-0900-z. Epub 2012 Sep 19.

    PMID: 22991135BACKGROUND

  • Hirano Y, Hattori M, Douden K, Shimizu S, Sato Y, Maeda K, Hashizume Y. Single-incision plus one port laparoscopic anterior resection for rectal cancer as a reduced port surgery. Scand J Surg. 2012;101(4):283-6. doi: 10.1177/145749691210100411.

    PMID: 23238505BACKGROUND

  • Zhang X, Yuan H, Tan Z, Li G, Xu Z, Zhou J, Fu J, Wu M, Xi J, Wang Y. Long-term outcomes of single-incision plus one-port laparoscopic surgery versus conventional laparoscopic surgery for rectosigmoid cancer: a randomized controlled trial. BMC Cancer. 2023 Dec 7;23(1):1204. doi: 10.1186/s12885-023-11500-2.

    PMID: 38062421DERIVED

  • Wang Y, Deng H, Mou T, Li J, Liu H, Zhou H, Li G. Short-term outcomes of single-incision plus one-port laparoscopic versus conventional laparoscopic surgery for rectosigmoid cancer: a randomized controlled trial. Surg Endosc. 2019 Mar;33(3):840-848. doi: 10.1007/s00464-018-6350-6. Epub 2018 Jul 13.

    PMID: 30006846DERIVED

  • Wang Y, Liu R, Zhang Z, Xue Q, Yan J, Yu J, Liu H, Zhao L, Mou T, Deng H, Li G. A safety study of transumbilical single incision versus conventional laparoscopic surgery for colorectal cancer: study protocol for a randomized controlled trial. Trials. 2015 Nov 30;16:539. doi: 10.1186/s13063-015-1067-5.

    PMID: 26620555DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Guoxin Li, M.D., PH.D.

    Nanfang Hospital, Southern Medical University, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoxin Li, M.D., PH.D.

CONTACT

+86-138-0277-1450gzliguoxin@163.com

Yanan Wang, M.D.

CONTACT

+86-150-1875-3181wyn8116@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

April 16, 2014

First Posted

April 21, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2017

Study Completion

April 1, 2022

Last Updated

April 21, 2014

Record last verified: 2014-04

Locations

CN(1)