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Status unknownNCT02117557Updated Apr 21, 2014

Safety Study of Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer

A Phase 2 interventional study of Single incision laparoscopic surgery and Conventional laparoscopic surgery in Colorectal Cancer, sponsored by Guoxin Li. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-04-21.

Sponsored by Guoxin Li · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
198
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Colorectal Cancer

Keywords

  • Single-incision
  • Laparoscopy
  • Colorectal Cancer
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.

This study's planned enrollment of 198 is above the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Guoxin Li is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
198 participants (estimated)

Study arms

  • Experimental
    Single incision laparoscopic surgery

    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

  • Active comparator
    Conventional laparoscopic surgery

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

    Procedure: Conventional laparoscopic surgery

Interventions

  • ProcedureSingle incision laparoscopic surgery

    Also known as: SILS

  • ProcedureConventional laparoscopic surgery

    Also known as: CLS

06

What researchers measure

Primary outcomes

  1. Early morbidity rate

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

    Time frame: 30 days

Secondary outcomes

  1. Operative outcomes

    Operative time, estimated blood loss and incision length are recorded.

    Time frame: intraoperative

  2. Pathological outecomes

    Tumor size, length of proximal and distal margin and lymph nodes harvested are used to assess oncological resection.

    Time frame: 5 days

  3. Postoperative recovery course

    Time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay are used to assess the postoperative recoverty course.

    Time frame: 14 days

  4. Pain score

    Postoperative pain is recorded using the visual analog scale (VAS) pain score tool on postoperative day 1, 2, 3 and the day of discharge.

    Time frame: 14 days

  5. Cosmetic assessment

    Cosmetic assessment is perform using body image scale and cosmetic scale.

    Time frame: 14 days

  6. 3-year disease free survival rate

    Time frame: 36 months

  7. 5-year overall survival rate

    Time frame: 60 months

  8. Inflammatory and immune response

    Time frame: 7 days

07

Study locations

1 of 1 sites recruiting
  • Nanfang Hospital, Southern Medical University
    Guangzhou, Guangdong 510-515, China
    • Guoxin Li, M.D.,PH.D. · Contact · gzliguoxin@163.com · +86-138-0277-1450
    • Guoxin Li, M.D.,PH.D. · Principal investigator
    • Yanan Wang, M.D. · Sub investigator
    • Haijun Deng, M.D.,PH.D. · Sub investigator
    • Qi Xue, M.D. · Sub investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 19966617 ↗
  • 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. PubMed 20734083 ↗
  • 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. PubMed 22991135 ↗
  • 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. PubMed 23238505 ↗
  • 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. PubMed 30006846 ↗
  • 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. PubMed 26620555 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02117557
Lead sponsor
Guoxin Li
Responsible party
Guoxin Li (M.D., Ph.D., Nanfang Hospital, Southern Medical University) — Sponsor-investigator
First posted
Apr 21, 2014
Start date
Apr 2014
Primary completion
Apr 2017 (estimated)
Completion
Apr 2022 (estimated)
Last update
Apr 21, 2014

Study contacts

Guoxin Li, M.D., PH.D.
Contact
gzliguoxin@163.com
+86-138-0277-1450
Yanan Wang, M.D.
Contact
wyn8116@163.com
+86-150-1875-3181
Guoxin Li, M.D., PH.D.
principal investigator · Nanfang Hospital, Southern Medical University, China

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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