The 'SILVERMAN1' Trial Single Incision Laparoscopic Versus Existing Resection (Minimal Access) for Neoplasia

NCT01319890 | Unknown DMC

• 1 other identifier: Silverman1
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Right Colon Tumors

Keywords

all histologic subtypes; benign; malignant

Outcome Measures

Primary Outcomes (8)

• operative time

  The length of time taken to complete each procedure will be recorded

  Within 3 months of surgery

• pain scores (visual analog scale)

  Pain scores will be calculated on day 1,2 and 3 post-operatively and on first clinic visit

  Within 90 days of surgery

• cosmesis satisfaction

  within 1 year of surgery

• Peri-operative complications will be recorded within 3 months of the index operation

  early morbidity- wound/respiratory / urinary sepsis, thromboembolic, cardiorespiratory, anastomotic leak, intra-abdominal abscess, reoperation

  within 3 months of surgery

• Intravenous narcotic/ oral analgesic requirements

  Patients analgesic requirements will be calculated both in-hospital and after discharge records will be detailed at clinic visit

  Within 3 months of surgery

• Resumption of intestinal function/ diet - Duration to discharge home - Return to normal activity

  Time to passage of flatus, bowel motion and dietary intake will be recorded while the patient is in hospital

  within 3 months of surgery

• Duration to discharge home

  Time patient is in hospital will be recorded on discharge from the unit

  within 3 months of date of surgery

• Return to normal activity/work

  The timeframe from surgery to resumption of normal activities of daily living and return to work will be determined at patients second clinic visit

  within 6 months of surgery

Secondary Outcomes (4)

• Lymph node yield

  within 3 months of surgery

• Conversion rate

  Within 3 months of surgery

• 30 day mortality

  within 3 months of surgery

• Cancer free survival

  5 years following the date of surgery

Study Arms (1)

Right Colectomy for colonic tumors

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

Procedure: Patients will be divided in two groups- those having right colectomy by standard laparoscopy and those having Single Incision Laparoscopic Surgery (SILS)

Interventions

Patients will be divided in two groups- those having right colectomy by standard laparoscopy and those having Single Incision Laparoscopic Surgery (SILS) PROCEDURE

Patients will be divided into 2 arms- those with right colon tumors treated by conventional laparoscopic right colectomy and those having a Single Incision Laparoscopic Surgery (SILS)

Right Colectomy for colonic tumors

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with histologically proven right colon tumors, benign and malignant, aged 18-85 years will be included.

You may qualify if:

• Age 18-85 years
• Histologic confirmation of right colonic cancer
• Informed consent

You may not qualify if:

• Inability to give informed consent (e.g. dementia)
• Previous midline laparotomy incision
• T4 tumour diagnosed on pre-operative imaging or intra-operatively
• Previous pelvic irradiation
• FAP/ HNPCC
• Colonic carcinoma against a background of ulcerative colitis.
• Emergent surgery for perforated/obstructing right colonic cancer
• Pregnancy

Sponsors & Collaborators

• Irish Clinical Outcomes in Research and Education: lead
• The Cleveland Clinic: collaborator

Study Sites (1)

St. Vincent's University Hospital

Dublin, Ireland

RECRUITING

Related Publications (21)

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  PMID: 14188905 BACKGROUND

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  BACKGROUND

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  PMID: 2841597 BACKGROUND

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  PMID: 1651562 BACKGROUND

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  PMID: 9809980 BACKGROUND

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  PMID: 12103285 BACKGROUND

• Clinical Outcomes of Surgical Therapy Study Group; Nelson H, Sargent DJ, Wieand HS, Fleshman J, Anvari M, Stryker SJ, Beart RW Jr, Hellinger M, Flanagan R Jr, Peters W, Ota D. A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med. 2004 May 13;350(20):2050-9. doi: 10.1056/NEJMoa032651.

  PMID: 15141043 BACKGROUND

• Guillou PJ, Quirke P, Thorpe H, Walker J, Jayne DG, Smith AM, Heath RM, Brown JM; MRC CLASICC trial group. Short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer (MRC CLASICC trial): multicentre, randomised controlled trial. Lancet. 2005 May 14-20;365(9472):1718-26. doi: 10.1016/S0140-6736(05)66545-2.

  PMID: 15894098 BACKGROUND

• http://www.acpgbi.org.uk/assets/documents/COLO_guides.pdf

  BACKGROUND

• Kim HJ, Lee JI, Lee YS, Lee IK, Park JH, Lee SK, Kang WK, Cho HM, You YK, Oh ST. Single-port transumbilical laparoscopic appendectomy: 43 consecutive cases. Surg Endosc. 2010 Nov;24(11):2765-9. doi: 10.1007/s00464-010-1043-9. Epub 2010 Apr 16.

  PMID: 20396909 BACKGROUND

• Podolsky ER, Curcillo PG 2nd. Single port access (SPA) surgery--a 24-month experience. J Gastrointest Surg. 2010 May;14(5):759-67. doi: 10.1007/s11605-009-1081-6. Epub 2010 Feb 13.

  PMID: 20155330 BACKGROUND

• Elsey JK, Feliciano DV. Initial experience with single-incision laparoscopic cholecystectomy. J Am Coll Surg. 2010 May;210(5):620-4, 624-6. doi: 10.1016/j.jamcollsurg.2009.12.030.

  PMID: 20421017 BACKGROUND

• Geisler DP, Condon ET, Remzi FH. Single incision laparoscopic total proctocolectomy with ileopouch anal anastomosis. Colorectal Dis. 2010 Sep;12(9):941-3. doi: 10.1111/j.1463-1318.2009.02115.x. Epub 2009 Nov 6.

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• Heeney A, O'Connor DB, Martin S, Winter DC. Single-port access laparoscopic surgery for complex Crohn's disease. Inflamm Bowel Dis. 2010 Aug;16(8):1273-4. doi: 10.1002/ibd.21163. No abstract available.

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• Uematsu D, Akiyama G, Matsuura M, Hotta K. Single-access laparoscopic colectomy with a novel multiport device in sigmoid colectomy for colon cancer. Dis Colon Rectum. 2010 Apr;53(4):496-501. doi: 10.1007/DCR.0b013e3181ce677a.

  PMID: 20305452 BACKGROUND

• Ramos-Valadez DI, Patel CB, Ragupathi M, Bartley Pickron T, Haas EM. Single-incision laparoscopic right hemicolectomy: safety and feasibility in a series of consecutive cases. Surg Endosc. 2010 Oct;24(10):2613-6. doi: 10.1007/s00464-010-1017-y. Epub 2010 Apr 3.

  PMID: 20364353 BACKGROUND

• Boni L, Dionigi G, Cassinotti E, Di Giuseppe M, Diurni M, Rausei S, Cantore F, Dionigi R. Single incision laparoscopic right colectomy. Surg Endosc. 2010 Dec;24(12):3233-6. doi: 10.1007/s00464-010-1100-4. Epub 2010 May 13.

  PMID: 20464415 BACKGROUND

Study Officials

• Des Winter, MD FRCSI

  St Vincent's University Hospital, Ireland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Des Winter, M.D. F.R.C.S.I.

CONTACT

winterd@indigo.ie

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2011
• First Posted: March 22, 2011
• Study Start: July 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2016
• Last Updated: April 3, 2012

Record last verified: 2012-03

Locations

IE (1)