NCT01862562

Brief Summary

Elderly patients have poorer preoperative conditions than younger patients. Therefore, minimally invasive surgery should be an effective treatment method for elderly patients. The investigators conducted a randomized trial that compared laparoscopic surgery and conventional open surgery in elderly patients who were 75 years old or over. The purpose of the present study was to clarify the effect of laparoscopic surgery in elderly patients. In our hypothesis of this trial, laparoscopic surgery is superior to conventional open surgery in short-term results, and same outcome in long -term results. Therefore, laparoscopic surgery would be recommended as standard procedure in an elderly colorectal patient.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3 colorectal-cancer

Timeline
Completed

Started Aug 2008

Longer than P75 for phase_3 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

November 26, 2013

Status Verified

November 1, 2013

Enrollment Period

4 years

First QC Date

May 16, 2013

Last Update Submit

November 24, 2013

Conditions

Colorectal Cancer

Keywords

Laparoscopic surgeryColorectal cancerElderly patientRandomized control study

Outcome Measures

Primary Outcomes (1)

  • Early complication rate

    All complication due to surgical procedure within 30 days after surgery

    30 days after surgery

Secondary Outcomes (4)

  • Overall survival

    5 years

  • Recurrence-free survival

    3 years

  • Length of postoperative hospital stay

    9 days

  • Health-related QOL score

    1 year after surgery

Study Arms (2)

Open surgery

ACTIVE COMPARATOR

Conventional procedure

Procedure: Open surgery

Laparoscopic surgery

EXPERIMENTAL

Minimum invasive procedure

Procedure: Laparoscopic surgery

Interventions

Open surgeryPROCEDURE

Conventional technique

Also known as: Open
Open surgery
Laparoscopic surgeryPROCEDURE

New minimum invasive technique

Also known as: Laparoscopic
Laparoscopic surgery

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age of 75 years old or over
  • Histologically proven adenocarcinoma
  • Clinical tumor penetrates visceral peritoneum (T4a), no metastasis (M0) or lower T factor
  • Elective operation
  • Tolerable surgery under general anesthesia
  • No bulky tumor larger than 8cm in diameter
  • No history of laparotomy for colorectal resection except appendectomy
  • Provided written informed consent

You may not qualify if:

  • Synchronous or metachronous (within 5 years) malignancy in another organ except carcinoma in situ
  • Multiple colorectal cancer that needs reconstruction two or more times
  • Acute intestinal obstruction or perforation due to colorectal cancer
  • Lower rectal cancer that required pelvic side wall lymphadenectomy
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yokohama City University Medical Center

Yokohama, Kanagawa, 232-0024, Japan

Location

Related Publications (1)

  • Ishibe A, Ota M, Fujii S, Suwa Y, Suzuki S, Suwa H, Momiyama M, Watanabe J, Watanabe K, Taguri M, Kunisaki C, Endo I. Midterm follow-up of a randomized trial of open surgery versus laparoscopic surgery in elderly patients with colorectal cancer. Surg Endosc. 2017 Oct;31(10):3890-3897. doi: 10.1007/s00464-017-5418-z. Epub 2017 Feb 15.

    PMID: 28205033DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Conversion to Open SurgeryLaparoscopy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

EndoscopyMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Chikara Kunisaki, Professor

    Yokohama City University, Gastroenterological Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 16, 2013

First Posted

May 24, 2013

Study Start

August 1, 2008

Primary Completion

August 1, 2012

Study Completion

August 1, 2017

Last Updated

November 26, 2013

Record last verified: 2013-11

Locations

JP(1)