Clinical trial · Interventional
Safety Study of Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
A Prospective Randomized Controlled Trial Comparing Transumbilical Single Incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
* 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional laparoscopic surgery | Procedure | — | UNRESOLVED |
| Single incision laparoscopic surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Single incision laparoscopic surgery
- description
- 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.
- interventionNames
- Procedure: Single incision laparoscopic surgery
- type
- ACTIVE_COMPARATOR
- label
- Conventional laparoscopic surgery
- description
- Conventional laparoscopic surgery for colorectal cancer will be performed for patients in this group.
- interventionNames
- Procedure: Conventional laparoscopic surgery
Primary outcomes (1)
- measure
- Early morbidity rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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: * 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
References
Publications (7)
- BACKGROUNDBucher 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 19966617
- BACKGROUNDGash 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 20734083
- BACKGROUNDLim 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 22991135
- BACKGROUNDHirano 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 23238505
- DERIVEDZhang 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 38062421
- DERIVEDWang 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 30006846
- DERIVEDWang 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.