ERAS in Laparoscopic Surgery for Colorectal Cancer: Risk Factors for Delayed Recovery

NCT ID: NCT02527967

Last Updated: 2015-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

143 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-02-28

Brief Summary

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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

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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

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Colonic Neoplasms Laparoscopy Perioperative Care

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1 (≤4 days)

Group 1 consisted of patients whose hospital stay was shorter or equal to the target LOS (≤ 4 days).

No interventions assigned to this group

Group 1 (>4 days)

In group 2 were patients whose hospital stay was longer than 4 days.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* colorectal cancer
* laparoscopic resection
* perioperative care according to ERAS principles

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jagiellonian University

OTHER

Sponsor Role lead

Responsible Party

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Michał Pędziwiatr

Michał Pędziwiatr, MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michał Pędziwiatr, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

2nd Department of Surgery, Jagiellonian University, Krakow, Poland

Locations

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2nd Department of General Surgery

Krakow, , Poland

Site Status

Countries

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Poland

References

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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.

Reference Type BACKGROUND
PMID: 23052794 (View on PubMed)

Nygren 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.

Reference Type BACKGROUND
PMID: 23062720 (View on PubMed)

Other Identifiers

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JagiellonianU-02

Identifier Type: -

Identifier Source: org_study_id

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