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OpenTrials
Completed

NCT Number: NCT01969591

Fast Track Laparoscopic Surgery: A Better Option for Treating Colorectal Cancer Than Conventional Laparoscopic Surgery

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

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Method: This study is a blinded randomized trial. 70 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. Outcome measures, length of hospital stay, postoperative surgical stress response (C reactive protein) and postoperative complications will be compared between the two groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

fast-track surgery

Procedure

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.

conventional postoperative surgery

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.

Primary outcomes

  1. Length of hospital stay

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

  2. Postoperative days

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

  3. First flatus time

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

  4. First defecation time

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

  5. solid diet time

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

Secondary outcomes

  1. Analgesics

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

  2. CRP (mg/L)

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

  3. Complications:anastomotic leakage,intestinal obstruction,wound infection

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Quan Wang

Other

Registry information

Acronym: FTS

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Oct 25, 2013
Registry last updated
Oct 25, 2013

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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