Colonic NeoplasmsNCT02527967
ERAS in Laparoscopic Surgery for Colorectal Cancer: Risk Factors for Delayed Recovery
An observational study of Colonic Neoplasms and Laparoscopy, run by Jagiellonian University at 1 site in Poland.
Trial summary
Although there is evidence for reducing complication rate and improving recovery after the implementation of Enhanced Recovery After Surgery (ERAS) protocols into colorectal surgery, most published papers include patients undergoing open resections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Neoplasms, Laparoscopy, Perioperative Care
- How many people
- 143 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2013to Feb 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The analysis included prospectively collected data from consecutive patients electively operated for colorectal cancer in the years 2013-2014. All patients were operated using laparoscopic surgery, and the perioperative care was based on pre-established ERAS protocol consisting of 13 items
Who may be able to join
- colorectal cancer
- laparoscopic resection
- perioperative care according to ERAS principles
Who cannot join
- Patients submitted initially for open or emergency surgery
- with complex cancer who required multi-organ resection
- patients treated with endoscopic techniques using the hybrid TaTME technique (Transanal Total Mesorectal Excision)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhanced Recovery After Surgery Protocol in Laparoscopic Surgery for Colorectal Cancer: Risk Factors for Delayed Recovery
Although there is evidence for reducing complication rate and improving recovery after the implementation of Enhanced Recovery After Surgery (ERAS) protocols into colorectal surgery, most published papers include patients undergoing open resections. The aim was to analyse factors affecting recovery and length of stay (LOS) in patients after laparoscopic colorectal surgery for cancer combined with ERAS protocol.
Read the detailed description
All patients were operated using laparoscopic surgery, and the perioperative care was based on pre-established ERAS protocol consisting of 13 pre and intraoperative items. Its principles and criteria for discharge from the hospital were based on the ERAS Society Guidelines.
Investigators analysed which of the factors: gender; age; BMI; ASA (American Society of Anaesthesiologists) physical status; type of surgery (colonic resection vs. rectal resection with total mesorectal excision, TME); stage of cancer; distance between the hospital and place of residence; operative time; intraoperative blood loss significantly prolong LOS (primary length of stay, excluding readmissions). Moreover, the compliance with ERAS protocol and its influence on LOS was analysed.
For the purposes of further analyses the entire group of patients was divided into 2 subgroups depending on the length of their hospital stay. On admission every patient received the information about the target length of stay of 4 days. Group 1 consisted of patients whose hospital stay was shorter or equal to the target LOS (≤ 4 days). In group 2 were patients whose hospital stay was longer than 4 days.
- Conditions
- Colonic Neoplasms, Laparoscopy, Perioperative Care
- Keywords
- colorectal cancer, enhanced recovery after surgery, perioperative care, fast-track surgery, laparoscopy, minimally invasive surgery, complications
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (≤4 days) | Group 1 consisted of patients whose hospital stay was shorter or equal to the target LOS (≤ 4 days). | |
| Group 1 (>4 days) | In group 2 were patients whose hospital stay was longer than 4 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay (days)
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 days
Secondary outcomes (3)
Compliance with ERAS protocol (%)
Compliance (%) will be calculated as the number of pre and intraoperative interventions fulfilled/13*100% (number of pre- and intraoperative protocol elements included into compliance calculations)
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 days
Complication rate (%)
Measured: up to 30 days post surgery
Readmission rate (%)
Measured: up to 30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startJan 2013
- Primary completionSep 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michał Pędziwiatr, Jagiellonian University
- Investigators
- Michał Pędziwiatr, MD, PhD, Principal investigator, 2nd Department of Surgery, Jagiellonian University, Krakow, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527967
- Sponsor's protocol ID
- JagiellonianU-02
- Status last verified
- Aug 2015
- First submitted
- 13 Aug 2015
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available.
PubMed 23052794Nygren J, Thacker J, Carli F, Fearon KC, Norderval S, Lobo DN, Ljungqvist O, Soop M, Ramirez J; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective rectal/pelvic surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):801-16. doi: 10.1016/j.clnu.2012.08.012. Epub 2012 Sep 26.
PubMed 23062720
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery Protocol in Laparoscopic Surgery for Colorectal Cancer: Risk Factors for Delayed Recovery
- ClinicalTrials.gov ID
- NCT02527967
- Acronym / sponsor ID
- JagiellonianU-02
- Conditions
- Colonic Neoplasms, Laparoscopy, Perioperative Care
- Keywords
- colorectal cancer, enhanced recovery after surgery, perioperative care, fast-track surgery, laparoscopy, minimally invasive surgery, complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although there is evidence for reducing complication rate and improving recovery after the implementation of Enhanced Recovery After Surgery (ERAS) protocols into colorectal surgery, most published papers include patients undergoing open resections. The aim was to analyse factors affecting recovery and length of stay (LOS) in patients after laparoscopic colorectal surgery for cancer combined with ERAS protocol.
Detailed description
All patients were operated using laparoscopic surgery, and the perioperative care was based on pre-established ERAS protocol consisting of 13 pre and intraoperative items. Its principles and criteria for discharge from the hospital were based on the ERAS Society Guidelines.
Investigators analysed which of the factors: gender; age; BMI; ASA (American Society of Anaesthesiologists) physical status; type of surgery (colonic resection vs. rectal resection with total mesorectal excision, TME); stage of cancer; distance between the hospital and place of residence; operative time; intraoperative blood loss significantly prolong LOS (primary length of stay, excluding readmissions). Moreover, the compliance with ERAS protocol and its influence on LOS was analysed.
For the purposes of further analyses the entire group of patients was divided into 2 subgroups depending on the length of their hospital stay. On admission every patient received the information about the target length of stay of 4 days. Group 1 consisted of patients whose hospital stay was shorter or equal to the target LOS (≤ 4 days). In group 2 were patients whose hospital stay was longer than 4 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (≤4 days) | – | –Group 1 consisted of patients whose hospital stay was shorter or equal to the target LOS (≤ 4 days). |
| Group 1 (>4 days) | – | –In group 2 were patients whose hospital stay was longer than 4 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The analysis included prospectively collected data from consecutive patients electively operated for colorectal cancer in the years 2013-2014. All patients were operated using laparoscopic surgery, and the perioperative care was based on pre-established ERAS protocol consisting of 13 items
Key inclusion criteria (3 listed)
- colorectal cancer
- laparoscopic resection
- perioperative care according to ERAS principles
Key exclusion criteria (3 listed)
- Patients submitted initially for open or emergency surgery
- with complex cancer who required multi-organ resection
- patients treated with endoscopic techniques using the hybrid TaTME technique (Transanal Total Mesorectal Excision)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospital length of stay (days)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
3 secondary outcomes
Compliance with ERAS protocol (%)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
Complication rate (%)
Time frame: up to 30 days post surgery
Readmission rate (%)
Time frame: up to 30 days post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
- Background: PubMed 23052794Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available.
- Background: PubMed 23062720Nygren J, Thacker J, Carli F, Fearon KC, Norderval S, Lobo DN, Ljungqvist O, Soop M, Ramirez J; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective rectal/pelvic surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):801-16. doi: 10.1016/j.clnu.2012.08.012. Epub 2012 Sep 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michał Pędziwiatr, MD, PhD principal investigator
2nd Department of Surgery, Jagiellonian University, Krakow, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Neoplasms and Laparoscopy, run by Jagiellonian University at 1 site in Poland.
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 3 inclusion and 3 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 19 Aug 2015. 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 Poland. 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?
Hospital length of stay (days) (time frame: participants will be followed for the duration of hospital stay, an expected average of 4 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 NCT02527967, which also lists 2 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 19 Aug 2015.