Clinical trial NCT01938313: Early Recovery After Surgery (ERAS) Versus Conventional Protocol After Laparoscopic Gastrectomy
Official title: Comparison of ERAS (Early Recovery After Surgery) Protocol With Conventional Protocol After Laparoscopic Gastrectomy: A Prospective Randomized Controlled Trial (Phase II Study))
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: gastric cancer
ERAS (early recovery after surgery)
fast track
laparoscopic gastrectomy
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2013-09-10
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Enhanced Recovery After Surgery (ERAS) programs have been introduced with purposes of reducing the surgical stress response and obtaining optimal recovery after surgery.

Detailed description: There is strong evidence of the usefulness of the ERAS programs in patients undergoing colorectal surgery in terms of significantly reduced postoperative complications and shorter length of hospital stay, compared to the patients of conventional treatment.

However, few studies exist about the implication of ERAS programs in the laparoscopic gastrectomy.

The aim of this study was to compare the recovery rate, morbidity, and quality of life in the patients undergoing laparoscopic gastrectomy for gastric cancer, receiving either ERAS protocol or conventional postoperative cares.

Eligibility criteria: Inclusion Criteria:

* Elective surgery
* American Society of Anesthesiologists (ASA) scores \< 3
* 20 \< Age \< 80
* Gastric cancer, adenocarcinoma, possible to perform laparoscopic distal gastrectomy
* Informed consent
* No other treatment (Radiation, Chemotherapy or Immunotherapy) on this gastric cancer or other type of cancer.
* No systemic inflammatory disease

Exclusion Criteria:

* Emergency operation

Primary outcomes:
measure: Recovering Rate
timeFrame: 4 days after surgery
Secondary outcomes:
measure: Postoperative length of hospital stay
timeFrame: up to 4 weeks after surgery
measure: Time to tolerance of a full diet
timeFrame: up to 1 month after surgery
measure: Time to first bowel motion Time to first bowel motion
timeFrame: up to 7 days after surgery
measure: Complications during the admissionTime to first bowel motion
timeFrame: up to 30 days after surgery
measure: Readmission rate
timeFrame: up to 30 days after surgery
measure: Pain scores based on a visual analog scale the day of surgery and the subsequent 3 days
timeFrame: up to 3 days after surgery
measure: Quality of life
timeFrame: up to 1 month after surgery
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Geynggi
Study officials:
affiliation: Department of Surgery, SNUBH
name: Hyung-Ho Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kang SH, Lee Y, Min SH, Park YS, Ahn SH, Park DJ, Kim HH. Multimodal Enhanced Recovery After Surgery (ERAS) Program is the Optimal Perioperative Care in Patients Undergoing Totally Laparoscopic Distal Gastrectomy for Gastric Cancer: A Prospective, Randomized, Clinical Trial. Ann Surg Oncol. 2018 Oct;25(11):3231-3238. doi: 10.1245/s10434-018-6625-0. Epub 2018 Jul 26.