AzTrials
AzTrials

Rectal CancerNCT03765411

Safe Colorectal Surgery in the Elderly

An observational study of Rectal Cancer, run by Tripler Army Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Rectal Cancer
What is being tested?
Proctectomy
Type of treatment
Surgery or procedure
How many people
6,740 participants
Where
1 siteUnited States
Study dates
1 Jan 2013to 15 Apr 2017
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • Older adult

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.

Who may be able to join

  • 70 years of age or older
  • underwent proctectomy

Who cannot join

  • emergent admissions
  • abdominoperineal resections

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859

Other trials in United States

About this study

Official title: Safe Surgery in the Elderly: A Review of Outcomes Following Robotic Proctectomy From the Nationwide Inpatient Sample, a Retrospective Cross Sectional Cohort Study. Cross-Sectional Study

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.

Conditions
Rectal Cancer
Being tested
Proctectomy
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProctectomyProcedure or surgery

    Resection of the rectum

Study groups in NCT03765411
Study groupRoleWhat they receive
Open Proctectomy PatientsPatients who underwent Proctectomy through an open approach
Receives: Procedure: Proctectomy
Laparoscopic Proctectomy PatientsPatients who underwent Proctectomy through a Laparoscopic approach
Receives: Procedure: Proctectomy
Robotic Proctectomy PatientsPatients who underwent Proctectomy through a Robotic approach
Receives: Procedure: Proctectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-hospital Complications

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

    Measured: through study completion, an average of 5 days

Secondary outcomes (3)

  1. In-hospital mortality

    Death during admission

    Measured: through study completion, an average of 5 days

  2. Length of Stay

    Length of in hospital stay

    Measured: 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

    Measured: through study completion, an average of 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2018
  2. Study start1 Jan 2013
  3. Primary completion15 Apr 2013
  4. Study completion15 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
6,740 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT03765411
Sponsor's protocol ID
Robotic Proct in the Elderly
Status last verified
Dec 2018
First submitted
28 Nov 2018
Last updated
5 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

An observational study of Rectal Cancer, run by Tripler Army Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-hospital Complications (time frame: through study completion, an average of 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03765411, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018; AzTrials last refreshed its copy on 31 Oct 2026.

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