Clinical trial · Observational
The 'SILVERMAN1' Trial Single Incision Laparoscopic Versus Existing Resection (Minimal Access) for Neoplasia
NCT01319890CI-TRIAL-00006646SILVERMAN 1unknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
Current evidence regarding the optimal surgical approach to potentially curable right colonic cancer is based on numerous, well designed randomised controlled clinical trials. Currently, eminence based opinion suggests that an alternative surgical technique, single incision laparoscopic surgery (SILS), may improve short and long term outcomes after minimally invasive right colonic resection. A true, prospective analysis comparing standard of care (laparoscopic right hemicolectomy) and this "new" therapy(SILS) has yet to be published. Having established the optimum treatment modality the minimally invasive approach to right colonic tumors the results will be communicated at national and international meetings.
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 |
|---|---|---|---|
| Right Colon Tumors | Colon Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patients will be divided in two groups- those having right colectomy by standard laparoscopy and those having Single Incision Laparoscopic Surgery (SILS) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Right Colectomy for colonic tumors
- description
- The group of patients enrolled will be patients with biopsy proven right colon tumors, both benign and malignant. These patients will then be subdivided into those having conventional laparoscopic right colectomy and SILS right colectomy
- interventionNames
- Procedure: Patients will be divided in two groups- those having right colectomy by standard laparoscopy and those having Single Incision Laparoscopic Surgery (SILS)
Primary outcomes (8)
- measure
- operative time
- timeFrame
- Within 3 months of surgery
- description
- The length of time taken to complete each procedure will be recorded
- measure
- pain scores (visual analog scale)
- timeFrame
- Within 90 days of surgery
- description
- Pain scores will be calculated on day 1,2 and 3 post-operatively and on first clinic visit
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-85 years 2. Histologic confirmation of right colonic cancer 3. Informed consent Exclusion Criteria: 1. Inability to give informed consent (e.g. dementia) 2. Previous midline laparotomy incision 3. T4 tumour diagnosed on pre-operative imaging or intra-operatively 4. Previous pelvic irradiation 5. FAP/ HNPCC 6. Colonic carcinoma against a background of ulcerative colitis. 7. Emergent surgery for perforated/obstructing right colonic cancer 8. Pregnancy
References
Publications (21)
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- BACKGROUNDSEER Cancer Statistics Review, 1975-2007, National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/csr/1975_2007/
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- BACKGROUNDCannon-Albright LA, Skolnick MH, Bishop DT, Lee RG, Burt RW. Common inheritance of susceptibility to colonic adenomatous polyps and associated colorectal cancers. N Engl J Med. 1988 Sep 1;319(9):533-7. doi: 10.1056/NEJM198809013190902. PMID 2841598
- BACKGROUNDVogelstein B, Fearon ER, Hamilton SR, Kern SE, Preisinger AC, Leppert M, Nakamura Y, White R, Smits AM, Bos JL. Genetic alterations during colorectal-tumor development. N Engl J Med. 1988 Sep 1;319(9):525-32. doi: 10.1056/NEJM198809013190901. PMID 2841597
- BACKGROUNDKinzler KW, Nilbert MC, Su LK, Vogelstein B, Bryan TM, Levy DB, Smith KJ, Preisinger AC, Hedge P, McKechnie D, et al. Identification of FAP locus genes from chromosome 5q21. Science. 1991 Aug 9;253(5020):661-5. doi: 10.1126/science.1651562. PMID 1651562
- BACKGROUNDResta N, Simone C, Mareni C, Montera M, Gentile M, Susca F, Gristina R, Pozzi S, Bertario L, Bufo P, Carlomagno N, Ingrosso M, Rossini FP, Tenconi R, Guanti G. STK11 mutations in Peutz-Jeghers syndrome and sporadic colon cancer. Cancer Res. 1998 Nov 1;58(21):4799-801.