NCT01969591

Brief Summary

To compare the outcomes of fast track laparoscopic surgery and conventional laparoscopic surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable colorectal-cancer

Status
completed

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

January 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 8, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 25, 2013

Completed
Last Updated

October 25, 2013

Status Verified

October 1, 2013

Enrollment Period

1.5 years

First QC Date

October 8, 2013

Last Update Submit

October 21, 2013

Conditions

Colorectal Cancer

Keywords

Fast track surgery, Laparoscopic surgery, colorectal cancer

Outcome Measures

Primary Outcomes (5)

  • Length of hospital stay

    with the first 30 days(plus or minus 3days) after surgery

  • Postoperative days

    with the first 30 days(plus or minus 3days) after surgery

  • First flatus time

    with the first 30 days(plus or minus 3days) after surgery

  • First defecation time

    with the first 30 days(plus or minus 3days) after surgery

  • solid diet time

    with the first 30 days(plus or minus 3days) after surgery

Secondary Outcomes (3)

  • Analgesics

    with the first 30 days(plus or minus 3days) after surgery

  • CRP (mg/L)

    with the first 30 days(plus or minus 3days) after surgery

  • Complications:anastomotic leakage,intestinal obstruction,wound infection

    one year

Study Arms (2)

fast-track surgery

EXPERIMENTAL

Patients with colorectal cancer will undergo laparoscopic colorectal resection, and will be divided into two groups. Protocols for fast-track group includes skipping preoperative mechanical bowel preparation, early restoration of diet and early postoperative ambulation.

Procedure: fast-track surgery

convontional postoperative care

OTHER

Patients with colorectal cancer will undergo laparoscopic colorectal resection, and will be divided into two groups. Protocols for fast-track group includes skipping preoperative mechanical bowel preparation, early restoration of diet and early postoperative ambulation.

Other: conventional postoperative surgery

Interventions

fast-track surgeryPROCEDURE

Patients with colorectal cancer will undergo laparoscopic colorectal resection, and will be divided into two groups. Protocols for fast-track group includes skipping preoperative mechanical bowel preparation, early restoration of diet and early postoperative ambulation.

fast-track surgery
conventional postoperative surgeryOTHER

Patients with colorectal cancer will undergo laparoscopic colorectal resection, and will be divided into two groups. Protocols for fast-track group includes skipping preoperative mechanical bowel preparation, early restoration of diet and early postoperative ambulation.

convontional postoperative care

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≤75 years
  • Good nutrition
  • no systemic infection
  • Elective laparoscopic surgery

You may not qualify if:

  • Age \>75 years
  • Malnutrition or an organ system infection
  • Associated with obstruction, bleeding, emergency surgery or surgical intervention
  • Tumor with extensive metastasis
  • Before operation patient was fasting, underwent gastrointestinal decompression and received nutritional support
  • Previous history of abdominal surgery
  • Patient had previously undergone gastrostomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy Director of General Surgery

Study Record Dates

First Submitted

October 8, 2013

First Posted

October 25, 2013

Study Start

January 1, 2011

Primary Completion

July 1, 2012

Study Completion

September 1, 2013

Last Updated

October 25, 2013

Record last verified: 2013-10