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Completed

NCT Number: NCT00606944

Fast-track Rehabilitation After Elective Colorectal and Small Bowel Resection

The purpose of this study is to address the question of whether or not oral alimentation and ambulation exercise should be begun early in patients following laparoscopic colorectal surgery compared to the classical diet and ambulation which depends on reappearance of functional intestinal transit. Early oral alimentation following laparoscopic colorectal surgery may decrease hospital stay and facilitate earlier discharge with comparable postoperative morbidity.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, Seoul National University Bundang Hospital, Seongnam, South Korea

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About this study

Traditionally, patients who received laparoscopic colorectal surgery were treated with the classical protocol including the use of a naso-gastric tube and starvation for several postoperative days till the recovery of bowel movement, or bed resting at immediate postoperative period followed by ward ambulation at the postoperative day 1 or 2. Restarting the oral alimentation is based on gas or feces reappearance after surgery and usually this is possible at several days following surgery. However, prolonged starvation might be uncomfortable for the patient as well as increasing his postoperative hospital stay. Recently, several studies reported the efficacy of early rehabilitation protocols after intestinal surgery, showing that early oral alimentation could reduce the length of hospital stay and cost of hospitalization without significant increase of postoperative complications, compared to traditional management.

This prospective, randomized study was designed to evaluate the effectiveness of a postoperative care pathway using rehabilitation with early ambulation and diet for patients undergoing elective laparoscopic colorectal resection compared with the traditional postoperative care.

In order to conduct this study, patients having a laparoscopic colon resection will be randomly attributed to enhanced recovery program group or control group, which is divided based on the postoperative management protocol.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Patients between 20 - 80 years old
  • Class ASA (American Society of Anesthesiology) I, II or III, +/- E
  • Patient willing to participate in the study
  • Patient who understands and accepts to sign the informed consent form
  • Patient who will undergo elective colorectal resection using laparoscopic surgery defined as follows: patients who received one of the following surgery:right hemicolectomy, left hemicolectomy, anterior resection with primary anastomosis, and low anterior resection with loop ileostomy for fecal diversion

Exclusion criteria

  • • Class ASA IV or V patient
  • Documented problem of gastro-intestinal motility
  • Combined resection of other organ than the colorectum
  • Presence of obstructive colorectal cancer associated with dilatation of the proximal gastrointestinal tract
  • Presence of residual peritoneal carcinosis at the end of surgery
  • Previous history of intra-abdominal surgery except simple appendectomy, cholecystectomy, or hysterectomy for uterine myoma
  • Creation of colo-rectal, colo-anal or ileo-anal anastomosis without loop ileostomy
  • Any per-surgery discovery which requires the use of a gastric drainage procedure following surgery
  • Any post-surgery change in patient condition which requires naso-gastric tube holding after surgery

Treatment and study plan

fast-track rehabilitation

Behavioral

fast-track rehabilitation with early ambulation and diet after elective colorectal resection

Primary outcomes

  1. the Length of Hospital Stay

    Time frame: at discharge

    discharge criteria

    • Tolerance of consecutive 3 soft bland diet
    • Unassisted ambulation
    • No necessity of analgesics
    • Afebrile without major complication
    • Willing to discharge
  2. Pain

    Time frame: at discharge

    score measured by the Visual Analog Scale

  3. Quality of Life

    Time frame: at discharge

    measured by SF-36

  4. Postoperative Complication During the First Admission

    Time frame: at discharge

  5. Recovery

    Time frame: at discharge

    recovery criteria must include all of the following

    • Tolerance of consecutive 3 soft bland diet
    • Unassisted ambulation
    • No necessity of analgesics
    • Afebrile without major complication

Secondary outcomes

  1. Readmission Rate

    Time frame: at postoperative day 30

  2. Pain

    Time frame: at postoperative day 30

    score measured by the Visual Analog Scale

  3. Quality of Life

    Time frame: at postoperative day 30

    measured by SF-36

  4. Postoperative Complication

    Time frame: at postoperative day 30

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Randomized Controlled Trial of Fast-Track Rehabilitation After Elective Colorectal and Small Bowel Resection

Important dates

Study start
2007
Primary completion
2009
Study completion
2011
First posted
Feb 5, 2008
Registry last updated
Aug 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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