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CompletedNCT03765411Updated Dec 5, 2018

Safe Colorectal Surgery in the Elderly

An observational study in Rectal Cancer, sponsored by Tripler Army Medical Center. Completed at 1 site in United States. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2018-12-05.

Sponsored by Tripler Army Medical Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
6,740
Ages
70 Years and older
Sex
All
01

Study summary

The objective was to evaluate the use and outcomes of robotic proctectomy compared to open and laparoscopic approaches for rectal cancer in the elderly. A retrospective cross-sectional cohort study utilizing the Nationwide Inpatient Sample (NIS; 2006-2013) was performed.

Read the detailed description

The objective was to evaluate the use and outcomes of robotic proctectomy compared to open and laparoscopic approaches for rectal cancer in the elderly. A retrospective cross-sectional cohort study utilizing the Nationwide Inpatient Sample (NIS; 2006-2013) was performed. All cases were restricted to age 70 years old or greater. The incidence of robotic proctectomy from 2006 - 2013 both as a whole as well as divided into approach was analyzed. Each approach was compared for both primary and secondary outcomes.

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Conditions studied

  • Rectal Cancer

Browse trials for

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Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Patients were eligible if they were 70 years old or greater, underwent proctectomy in an elective setting, and did not have an abdominoperioneal resection.

Inclusion criteria

  • 70 years of age or older
  • underwent proctectomy

Exclusion criteria

Exclusion Criteria:

  • emergent admissions
  • abdominoperineal resections
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
6,740 participants (actual)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • Open Proctectomy Patients

    Patients who underwent Proctectomy through an open approach

    Procedure: Proctectomy

  • Laparoscopic Proctectomy Patients

    Patients who underwent Proctectomy through a Laparoscopic approach

    Procedure: Proctectomy

  • Robotic Proctectomy Patients

    Patients who underwent Proctectomy through a Robotic approach

    Procedure: Proctectomy

Interventions

  • ProcedureProctectomy

    Resection of the rectum

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What researchers measure

Primary outcomes

  1. In-hospital Complications

    Complications to include mechanical wound, infections, urinary, pulmonary, gastrointestinal, cardiovascular, systemic, surgical, and any complication

    Time frame: through study completion, an average of 5 days

Secondary outcomes

  1. In-hospital mortality

    Death during admission

    Time frame: through study completion, an average of 5 days

  2. Length of Stay

    Length of in hospital stay

    Time frame: through study completion, an average of 5 days

  3. Costs and Charges

    Hospital charges refer to the total amount billed by the hospital. Hospital cost refers to the amount paid by the insurance provider

    Time frame: through study completion, an average of 5 days

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Study locations

1 site
  • Tripler Army Medical Center
    Honolulu, Hawaii 96859, United States
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References and documents

Publications

  • Guiding principles for the care of older adults with multimorbidity: an approach for clinicians. Guiding principles for the care of older adults with multimorbidity: an approach for clinicians: American Geriatrics Society Expert Panel on the Care of Older Adults with Multimorbidity. J Am Geriatr Soc. 2012 Oct;60(10):E1-E25. doi: 10.1111/j.1532-5415.2012.04188.x. Epub 2012 Sep 19. No abstract available. PubMed 22994865 ↗
  • Fielding LP, Phillips RK, Hittinger R. Factors influencing mortality after curative resection for large bowel cancer in elderly patients. Lancet. 1989 Mar 18;1(8638):595-7. doi: 10.1016/s0140-6736(89)91618-8. PubMed 2564119 ↗
  • Tan KY, Kawamura Y, Mizokami K, Sasaki J, Tsujinaka S, Maeda T, Konishi F. Colorectal surgery in octogenarian patients--outcomes and predictors of morbidity. Int J Colorectal Dis. 2009 Feb;24(2):185-9. doi: 10.1007/s00384-008-0615-9. Epub 2008 Dec 3. PubMed 19050901 ↗
  • Law WL, Chu KW, Tung PH. Laparoscopic colorectal resection: a safe option for elderly patients. J Am Coll Surg. 2002 Dec;195(6):768-73. doi: 10.1016/s1072-7515(02)01483-7. PubMed 12495308 ↗
  • Cheung HY, Chung CC, Fung JT, Wong JC, Yau KK, Li MK. Laparoscopic resection for colorectal cancer in octogenarians: results in a decade. Dis Colon Rectum. 2007 Nov;50(11):1905-10. doi: 10.1007/s10350-007-9070-x. Epub 2007 Sep 26. PubMed 17899275 ↗
  • Stocchi L, Nelson H, Young-Fadok TM, Larson DR, Ilstrup DM. Safety and advantages of laparoscopic vs. open colectomy in the elderly: matched-control study. Dis Colon Rectum. 2000 Mar;43(3):326-32. doi: 10.1007/BF02258297. PubMed 10733113 ↗
  • Vignali A, Di Palo S, Tamburini A, Radaelli G, Orsenigo E, Staudacher C. Laparoscopic vs. open colectomies in octogenarians: a case-matched control study. Dis Colon Rectum. 2005 Nov;48(11):2070-5. doi: 10.1007/s10350-005-0147-0. PubMed 16086219 ↗
  • Champagne BJ, Delaney CP. Laparoscopic approaches to rectal cancer. Clin Colon Rectal Surg. 2007 Aug;20(3):237-48. doi: 10.1055/s-2007-984868. PubMed 20011205 ↗
  • Jayne DG, Brown JM, Thorpe H, Walker J, Quirke P, Guillou PJ. Bladder and sexual function following resection for rectal cancer in a randomized clinical trial of laparoscopic versus open technique. Br J Surg. 2005 Sep;92(9):1124-32. doi: 10.1002/bjs.4989. PubMed 15997446 ↗
  • van der Pas MH, Haglind E, Cuesta MA, Furst A, Lacy AM, Hop WC, Bonjer HJ; COlorectal cancer Laparoscopic or Open Resection II (COLOR II) Study Group. Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial. Lancet Oncol. 2013 Mar;14(3):210-8. doi: 10.1016/S1470-2045(13)70016-0. Epub 2013 Feb 6. PubMed 23395398 ↗
  • Park S, Kim NK. The Role of Robotic Surgery for Rectal Cancer: Overcoming Technical Challenges in Laparoscopic Surgery by Advanced Techniques. J Korean Med Sci. 2015 Jul;30(7):837-46. doi: 10.3346/jkms.2015.30.7.837. Epub 2015 Jun 10. PubMed 26130943 ↗
  • Baik SH, Kwon HY, Kim JS, Hur H, Sohn SK, Cho CH, Kim H. Robotic versus laparoscopic low anterior resection of rectal cancer: short-term outcome of a prospective comparative study. Ann Surg Oncol. 2009 Jun;16(6):1480-7. doi: 10.1245/s10434-009-0435-3. Epub 2009 Mar 17. PubMed 19290486 ↗
  • Kim JY, Kim NK, Lee KY, Hur H, Min BS, Kim JH. A comparative study of voiding and sexual function after total mesorectal excision with autonomic nerve preservation for rectal cancer: laparoscopic versus robotic surgery. Ann Surg Oncol. 2012 Aug;19(8):2485-93. doi: 10.1245/s10434-012-2262-1. Epub 2012 Mar 21. PubMed 22434245 ↗
  • D'Annibale A, Pernazza G, Monsellato I, Pende V, Lucandri G, Mazzocchi P, Alfano G. Total mesorectal excision: a comparison of oncological and functional outcomes between robotic and laparoscopic surgery for rectal cancer. Surg Endosc. 2013 Jun;27(6):1887-95. doi: 10.1007/s00464-012-2731-4. Epub 2013 Jan 5. PubMed 23292566 ↗
  • Frasson M, Braga M, Vignali A, Zuliani W, Di Carlo V. Benefits of laparoscopic colorectal resection are more pronounced in elderly patients. Dis Colon Rectum. 2008 Mar;51(3):296-300. doi: 10.1007/s10350-007-9124-0. Epub 2008 Jan 15. PubMed 18197453 ↗
  • Jayne D, Pigazzi A, Marshall H, Croft J, Corrigan N, Copeland J, Quirke P, West N, Rautio T, Thomassen N, Tilney H, Gudgeon M, Bianchi PP, Edlin R, Hulme C, Brown J. Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial. JAMA. 2017 Oct 24;318(16):1569-1580. doi: 10.1001/jama.2017.7219. PubMed 29067426 ↗
  • Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8. PubMed 3558716 ↗
  • Elixhauser A, Steiner C, Harris DR, Coffey RM. Comorbidity measures for use with administrative data. Med Care. 1998 Jan;36(1):8-27. doi: 10.1097/00005650-199801000-00004. PubMed 9431328 ↗
  • Washington CW, Derdeyn CP, Dacey RG Jr, Dhar R, Zipfel GJ. Analysis of subarachnoid hemorrhage using the Nationwide Inpatient Sample: the NIS-SAH Severity Score and Outcome Measure. J Neurosurg. 2014 Aug;121(2):482-9. doi: 10.3171/2014.4.JNS131100. Epub 2014 Jun 20. PubMed 24949676 ↗
  • Singh JA, Kwoh CK, Boudreau RM, Lee GC, Ibrahim SA. Hospital volume and surgical outcomes after elective hip/knee arthroplasty: a risk-adjusted analysis of a large regional database. Arthritis Rheum. 2011 Aug;63(8):2531-9. doi: 10.1002/art.30390. PubMed 21656509 ↗
  • Schlussel AT, Lustik MB, Johnson EK, Maykel JA, Champagne BJ, Damle A, Ross HM, Steele SR. A nationwide assessment comparing nonelective open with minimally invasive complex colorectal procedures. Colorectal Dis. 2016 Mar;18(3):301-11. doi: 10.1111/codi.13113. PubMed 26362693 ↗
  • Damle A, Damle RN, Flahive JM, Schlussel AT, Davids JS, Sturrock PR, Maykel JA, Alavi K. Diffusion of technology: Trends in robotic-assisted colorectal surgery. Am J Surg. 2017 Nov;214(5):820-824. doi: 10.1016/j.amjsurg.2017.03.020. Epub 2017 Mar 21. PubMed 28347491 ↗
  • Lee MG, Chiu CC, Wang CC, Chang CN, Lee SH, Lee M, Hsu TC, Lee CC. Trends and Outcomes of Surgical Treatment for Colorectal Cancer between 2004 and 2012- an Analysis using National Inpatient Database. Sci Rep. 2017 May 17;7(1):2006. doi: 10.1038/s41598-017-02224-y. PubMed 28515452 ↗
  • Halabi WJ, Kang CY, Jafari MD, Nguyen VQ, Carmichael JC, Mills S, Stamos MJ, Pigazzi A. Robotic-assisted colorectal surgery in the United States: a nationwide analysis of trends and outcomes. World J Surg. 2013 Dec;37(12):2782-90. doi: 10.1007/s00268-013-2024-7. PubMed 23564216 ↗
  • Tam MS, Kaoutzanis C, Mullard AJ, Regenbogen SE, Franz MG, Hendren S, Krapohl G, Vandewarker JF, Lampman RM, Cleary RK. A population-based study comparing laparoscopic and robotic outcomes in colorectal surgery. Surg Endosc. 2016 Feb;30(2):455-463. doi: 10.1007/s00464-015-4218-6. Epub 2015 Apr 17. PubMed 25894448 ↗
  • Baek JH, Pastor C, Pigazzi A. Robotic and laparoscopic total mesorectal excision for rectal cancer: a case-matched study. Surg Endosc. 2011 Feb;25(2):521-5. doi: 10.1007/s00464-010-1204-x. Epub 2010 Jul 7. PubMed 20607559 ↗
  • Schlussel AT, Delaney CP, Maykel JA, Lustik MB, Nishtala M, Steele SR. A National Database Analysis Comparing the Nationwide Inpatient Sample and American College of Surgeons National Surgical Quality Improvement Program in Laparoscopic vs Open Colectomies: Inherent Variance May Impact Outcomes. Dis Colon Rectum. 2016 Sep;59(9):843-54. doi: 10.1097/DCR.0000000000000642. PubMed 27505113 ↗
  • Antoniou SA, Antoniou GA, Koch OO, Pointner R, Granderath FA. Laparoscopic colorectal surgery confers lower mortality in the elderly: a systematic review and meta-analysis of 66,483 patients. Surg Endosc. 2015 Feb;29(2):322-33. doi: 10.1007/s00464-014-3672-x. Epub 2014 Jul 2. PubMed 24986017 ↗
  • Seishima R, Okabayashi K, Hasegawa H, Tsuruta M, Shigeta K, Matsui S, Yamada T, Kitagawa Y. Is laparoscopic colorectal surgery beneficial for elderly patients? A systematic review and meta-analysis. J Gastrointest Surg. 2015 Apr;19(4):756-65. doi: 10.1007/s11605-015-2748-9. Epub 2015 Jan 24. PubMed 25617077 ↗
  • Park JS, Choi GS, Lim KH, Jang YS, Jun SH. Robotic-assisted versus laparoscopic surgery for low rectal cancer: case-matched analysis of short-term outcomes. Ann Surg Oncol. 2010 Dec;17(12):3195-202. doi: 10.1245/s10434-010-1162-5. Epub 2010 Jun 30. PubMed 20589436 ↗
  • Keller DS, Senagore AJ, Lawrence JK, Champagne BJ, Delaney CP. Comparative effectiveness of laparoscopic versus robot-assisted colorectal resection. Surg Endosc. 2014 Jan;28(1):212-21. doi: 10.1007/s00464-013-3163-5. Epub 2013 Aug 31. PubMed 23996335 ↗
  • Li Y, Wang S, Gao S, Yang C, Yang W, Guo S. Laparoscopic colorectal resection versus open colorectal resection in octogenarians: a systematic review and meta-analysis of safety and efficacy. Tech Coloproctol. 2016 Mar;20(3):153-62. doi: 10.1007/s10151-015-1419-x. Epub 2016 Jan 18. PubMed 26783029 ↗
  • Park JS, Choi GS, Lim KH, Jang YS, Jun SH. S052: a comparison of robot-assisted, laparoscopic, and open surgery in the treatment of rectal cancer. Surg Endosc. 2011 Jan;25(1):240-8. doi: 10.1007/s00464-010-1166-z. Epub 2010 Jun 15. PubMed 20552367 ↗
  • Agha RA, Borrelli MR, Vella-Baldacchino M, Thavayogan R, Orgill DP; STROCSS Group. The STROCSS statement: Strengthening the Reporting of Cohort Studies in Surgery. Int J Surg. 2017 Oct;46:198-202. doi: 10.1016/j.ijsu.2017.08.586. Epub 2017 Sep 7. PubMed 28890409 ↗

Individual participant data

Plan to share: Undecided

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Registry details

Key details

Study ID
NCT03765411
Lead sponsor
Tripler Army Medical Center
Collaborators
Madigan Army Medical Center
Responsible party
Carly R Richards (General Surgery Chief Resident Surgeon, Tripler Army Medical Center) — Principal investigator
First posted
Dec 5, 2018
Start date
Jan 1, 2013
Primary completion
Apr 15, 2013
Completion
Apr 15, 2017
Last update
Dec 5, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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