CHASE : aCcelerated 23-Hour erAS Care for Colorectal Surgery

NCT04461275 | Completed DMC

• 1 other identifier: Z20202017
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Throughout the years, there has been a rapid change in the perioperative protocols and procedures surrounding colorectal surgery. Upon the introduction of the Enhanced Recovery After Surgery (ERAS) program in Western countries, an improvement in postoperative outcomes was seen. Nowadays, researchers focus on further improving the current standard ERAS programs enabling an accelerated version hereof. Objective: The aim of this study is to investigate the feasibility and safety of a 23-hour accelerated ERAS protocol (ERAS 2.0) for patients undergoing colorectal surgery compared to a retrospective cohort of patients who followed ERAS 1.0 for colorectal surgery. In this ERAS 2.0 protocol, patients undergoing colorectal surgery will be discharged within 23 hours after surgery. Study design: This study is an investigator-initiated, single-center prospective study. Study population: Patients aged ≥ 18 years ≤ 80 undergoing surgical resection for colorectal pathology that meet the eligibility criteria will be invited to participate in this study. Intervention: Adhering to a strict multidisciplinary and multifaceted ERAS 2.0 protocol, patients receiving elective colorectal surgery will be discharged 23-hours after surgery. Main study parameters/endpoints: Rate of the successful and safe application of the 23-hour accelerated ERAS 2.0 protocol for patients undergoing elective colorectal surgery. Success rate will be measured in readmission rate and safety will be measured with rate of serious adverse events (Clavien Dindo ≥3b). Success rate (feasibility) will also be measured in percentage of patients who were not able to be discharged 23 hours after surgery.

Conditions

Colorectal Cancer; Enhanced Recovery After Surgery

Keywords

Colorectal Cancer; Enhanced Recovery After Surgery; Accelerated Care; Truly Minimally Invasive Surgery

Outcome Measures

Primary Outcomes (1)

• Rate of the successful and safe application of the 23-hour accelerated ERAS 2.0 protocol for patients undergoing elective colorectal surgery.

  Success rate (feasibility) will be measured in readmission rate and safety will be measured with rate of serious adverse events (Clavien Dindo ≥3b).

  30 days

Secondary Outcomes (3)

• • Number of Participants who develop Postoperative Complications within 30 days

  30 day

• • Number of Participants with Postoperative Mortality within 30 days

  30 days

• • Patient satisfaction evaluation by means of a questionnaire to evaluate the patients subjective experience during the duration of this study.

  10 days

Other Outcomes (4)

• • Demographic parameters

  Upon inclusion

• • Disease related demographics

  After surgery and within 14 days after surgery

• • Short Nutritional Assessment Questionnaire (SNAQ)

  Upon inclusion

Study Arms (1)

ERAS 2.0 group

EXPERIMENTAL

Patients included in the ERAS 2.0 group will follow the ERAS 2.0 accelerated care protocol.

Other: ERAS 2.0

Interventions

ERAS 2.0 OTHER

ERAS 2.0 accelerated protocol with adequate fluid management, pain control and truly minimally invasive surgery (intracorporeal anastomosis)

ERAS 2.0 group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent;
• Is ≥ 18 years ≤ 80;
• BMI ≤ 35 kg/m2;
• WHO performance status = 0
• Is diagnosed with (non-complicated) colorectal cancer
• Is scheduled to undergo elective laparoscopic colorectal surgery (ileocecal resection, right or left hemicolectomy, transvers colon resection) with primary anastomosis;
• Primary anastomosis is performed intracorporeally;
• Uncomplicated operation;
• Readily available ambulant care provided by an adult family member for the first 24 hours after discharge;
• Patient is adequately reachable by phone.

You may not qualify if:

• ASA classification ≥ 3;
• Subjects who have limited mobility and/or need to be aided/assisted when mobilizing;
• Subjects with a history of active pulmonary infection, any other active infection, any uncontrolled medical disease
• Subjects with a contraindication for oral NSAIDs;
• Subjects with a contraindication for spinal anesthesia;
• Subjects requiring parenteral nutrition prior to surgery;
• Subjects scheduled to undergo lower rectal resections;
• Subjects receiving an ostomy;
• Subjects who experience complications preoperatively;
• Subjects who are mentally incompetent, challenged or requiring aid with daily life activities.

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (1)

Zuyderland Medical Center

Sittard, Limburg, 6162 BG, Netherlands

Location

Related Publications (6)

• Al-Mazrou AM, Chiuzan C, Kiran RP. Factors influencing discharge disposition after colectomy. Surg Endosc. 2018 Jul;32(7):3032-3040. doi: 10.1007/s00464-017-6013-z. Epub 2017 Dec 27.

  PMID: 29282575 BACKGROUND

• Dobradin A, Ganji M, Alam SE, Kar PM. Laparoscopic colon resections with discharge less than 24 hours. JSLS. 2013 Apr-Jun;17(2):198-203. doi: 10.4293/108680813X13654754535791.

  PMID: 23925012 BACKGROUND

• Chand M, De'Ath HD, Rasheed S, Mehta C, Bromilow J, Qureshi T. The influence of peri-operative factors for accelerated discharge following laparoscopic colorectal surgery when combined with an enhanced recovery after surgery (ERAS) pathway. Int J Surg. 2016 Jan;25:59-63. doi: 10.1016/j.ijsu.2015.11.047. Epub 2015 Nov 30.

  PMID: 26654893 BACKGROUND

• Rossi G, Vaccarezza H, Vaccaro CA, Mentz RE, Im V, Alvarez A, Quintana GO. Two-day hospital stay after laparoscopic colorectal surgery under an enhanced recovery after surgery (ERAS) pathway. World J Surg. 2013 Oct;37(10):2483-9. doi: 10.1007/s00268-013-2155-x.

  PMID: 23881088 RESULT

• Emmanuel A, Chohda E, Botfield C, Ellul J. Accelerated discharge within 72 hours of colorectal cancer resection using simple discharge criteria. Ann R Coll Surg Engl. 2018 Jan;100(1):52-56. doi: 10.1308/rcsann.2017.0149. Epub 2017 Sep 15.

  PMID: 29022790 RESULT

• Levy BF, Scott MJ, Fawcett WJ, Rockall TA. 23-hour-stay laparoscopic colectomy. Dis Colon Rectum. 2009 Jul;52(7):1239-43. doi: 10.1007/DCR.0b013e3181a0b32d.

  PMID: 19571699 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• James van Bastelaar, M.D., PhD

  GE-, Oncologic-surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is an investigator-initiated, single-center prospective feasibility study. This feasibility study will compare 30 consecutive patients following the ERAS 2.0 program to 30 patients of a retrospective cohort who followed the current standard ERAS 1.0 protocol.

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 8, 2020
• Study Start: June 19, 2020
• Primary Completion: August 30, 2021
• Study Completion: September 30, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)