Gynecologic DiseaseERASNCT03629626
Enhanced Recovery After Surgery (ERAS) in Gynecological Surgery (ERASGS-01)
A study testing ERAS protocol in people with Gynecologic Disease and Gynecologic Cancer, run by Shandong University at 1 site in China.
Trial summary
Enhanced recovery programs are composed of preoperative, intraoperative and postoperative strategies combined to form a multi-modal pathway. ERAS requires a multidisciplinary team of anesthetists, surgeons and nurses for successful implementation and realization of its advantages.The aim of this study is to compare… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Gynecologic Disease, Gynecologic Cancer
- What is being tested?
- ERAS protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2018to 31 Dec 2021
- Phase
- Interventional
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 and <70 years old
- Patients candidated for elective gynecological surgery for benign pathology
- Patients with diagnosis of gynecological neoplasm and candidated for elective gynecological surgery
- Signed consent form
Who cannot join
- Contraindication to loco-regional anaesthesia
- Patients with ileus or subocclusive condition prior surgery
- Coagulation disorders
- Organ failure or severe disfunction (heart, renal, pulmonary, hepatic)
- Uncontrolled hypertension (>180/95)
- Alcohol or drug abuser (current or previous)
- Psychiatric condition or language barriers
- Planned Intensive Care Recovery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized Trial Comparing ERAS and Conventional Protocol for Perioperative Care of Patients After Gynecological Surgery
Enhanced recovery programs are composed of preoperative, intraoperative and postoperative strategies combined to form a multi-modal pathway. ERAS requires a multidisciplinary team of anesthetists, surgeons and nurses for successful implementation and realization of its advantages.The aim of this study is to compare outcomes of conventional perioperative care with those of an enhanced recovery after surgery (ERAS) perioperative care plan in women undergoing surgery for gynecologic cancer or suspected gynecologic disease.
Read the detailed description
The study design is a two-arm, randomized, controlled trial. The control arm will consist of standard conventional perioperative care. The intervention arm will consist of a protocol-driven ERAS program. The investigators believe that this information will be very useful because although there is a national interest in creating ERAS protocols for gynecology, there currently is very little published on the subject. Investigators hypothesize that those patients randomized to the ERAS protocol will have shorter lengths of hospital stay and complications, without increasing readmission rates. The investigators would like to publish the investigators' results and protocol as a resource for other institutions to adopt.
- Conditions
- Gynecologic Disease, Gynecologic Cancer
- Being tested
- ERAS protocol
- Keywords
- preoperative / intraoperative/ postoperative management
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS protocolProcedure or surgery
preoperative management Optimization of relevant medical uncontrolled situations, avoid fasting, avoid bowel preparation, avoid premedications, nutritional assessment, stop smoking, stop alcohol and appropriate counselling
intraoperative management Multimodal prevention of prophylaxis against nausea and vomiting (PONV) (according to preoperative assessment of Apfel Score) with a combination of multiple antiemetic drugs.
postoperative management Postoperative pain control is obtained with opioid sparing strategies, in order to avoid Post Operative Ileus (POI) and PONV.
It is proposed to chew gum three times daily , fluid therapy, early mobilization, early feeding within 2 hours postoperative for at least 15 minutes and eventually to promote a faster bowel function.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Perioperative (SP) care | No intervention | Conventional Perioperative (SP) care |
| ERAS protocol | Experimental | preoperative / intraoperative/ postoperative management Receives: Procedure: ERAS protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shorter Length Of Hospitalization (LOH)
Total amount of days spent in hospital
Measured: Up to 4 weeks after surgery
Secondary outcomes (12)
Assessment of postoperative pain
Measurement of pain score post-operation will be obtained using clinical data gathered by the care team providing routine clinical care, and asking routine pain score questions. The scale used is the standard 1-10 pain scale, with 1 being no pain or very mild discomfort, and 10 being very severe pain.
Measured: At moment 24 hours after surgery
Presence/Absence of nausea
Treatment for postoperative nausea
Measured: At moment 0, 3, 6, 12 and 24 hours after surgery
Presence/Absence of vomiting
Treatment for postoperative vomiting
Measured: At moment 0, 3, 6, 12 and 24 hours after surgery
Time to flatus
Hours elapsed to event
Measured: Up to 4 weeks after surgery
Time to bowel movement
Hours elapsed to event
Measured: Up to 4 weeks after surgery
Foley catheter removal
Time to Foley catheter removal postoperative
Measured: From 1 to 14days post surgery
Time to drink
Hours elapsed to event
Measured: Up to 4 weeks after surgery
Time to eating
Hours elapsed to event
Measured: Up to 4 weeks after surgery
Time to walking
Hours elapsed to event
Measured: Up to 4 weeks after surgery
Postoperative complications
Rate measurement
Measured: Up to 2 weeks after surgery
Time to adjuvant treatment
Time participant receives adjuvant treatment, if needed (chemotherapy or radiation)
Measured: 60 days
Readmission rates
Readmissions to the hospital
Measured: Up to 21 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 posted14 Aug 2018
- Study start15 Aug 2018
- Primary completion30 Jun 2021
- Study completion31 Dec 2021
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 Gynecologic DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beihua Kong, Shandong University
- Investigators
- Beihua Kong, MD.PhD., Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629626
- Sponsor's protocol ID
- ERASGS-01
- Acronym
- ERAS
- Status last verified
- Apr 2023
- First submitted
- 10 Aug 2018
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xing N, Wang H, Huang Y, Peng J. Enhanced recovery after surgery program alleviates neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio in patients undergoing gynecological surgery. Front Med (Lausanne). 2023 Apr 17;10:1057923. doi: 10.3389/fmed.2023.1057923. eCollection 2023.
PubMed 37138751Peng J, Dong R, Jiao J, Liu M, Zhang X, Bu H, Dong P, Zhao S, Xing N, Feng S, Yang X, Kong B. Enhanced Recovery After Surgery Impact on the Systemic Inflammatory Response of Patients Following Gynecological Oncology Surgery: A Prospective Randomized Study. Cancer Manag Res. 2021 Jun 1;13:4383-4392. doi: 10.2147/CMAR.S294718. eCollection 2021.
PubMed 34103993
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Trial Comparing ERAS and Conventional Protocol for Perioperative Care of Patients After Gynecological Surgery
- ClinicalTrials.gov ID
- NCT03629626
- Acronym / sponsor ID
- ERAS / ERASGS-01
- Conditions
- Gynecologic Disease, Gynecologic Cancer
- Keywords
- preoperative / intraoperative/ postoperative management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 Aug 2018 (actual)
- 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.
Enhanced recovery programs are composed of preoperative, intraoperative and postoperative strategies combined to form a multi-modal pathway. ERAS requires a multidisciplinary team of anesthetists, surgeons and nurses for successful implementation and realization of its advantages.The aim of this study is to compare outcomes of conventional perioperative care with those of an enhanced recovery after surgery (ERAS) perioperative care plan in women undergoing surgery for gynecologic cancer or suspected gynecologic disease.
Detailed description
The study design is a two-arm, randomized, controlled trial. The control arm will consist of standard conventional perioperative care. The intervention arm will consist of a protocol-driven ERAS program. The investigators believe that this information will be very useful because although there is a national interest in creating ERAS protocols for gynecology, there currently is very little published on the subject. Investigators hypothesize that those patients randomized to the ERAS protocol will have shorter lengths of hospital stay and complications, without increasing readmission rates. The investigators would like to publish the investigators' results and protocol as a resource for other institutions to adopt.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Perioperative (SP) care | No intervention | –Conventional Perioperative (SP) care |
| ERAS protocol | Experimental | Procedure: ERAS protocolpreoperative / intraoperative/ postoperative management |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 and <70 years old
- Patients candidated for elective gynecological surgery for benign pathology
- Patients with diagnosis of gynecological neoplasm and candidated for elective gynecological surgery
- Signed consent form
Key exclusion criteria (8 listed)
- Contraindication to loco-regional anaesthesia
- Patients with ileus or subocclusive condition prior surgery
- Coagulation disorders
- Organ failure or severe disfunction (heart, renal, pulmonary, hepatic)
- Uncontrolled hypertension (>180/95)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERAS protocolpreoperative management Optimization of relevant medical uncontrolled situations, avoid fasting, avoid bowel preparation, avoid premedications, nutritional assessment, stop smoking, stop alcohol and appropriate counselling intraoperative management Multimodal prevention of prophylaxis against nausea and vomiting (PONV) (according to preoperative assessment of Apfel Score) with a combination of multiple antiemetic drugs. postoperative management Postoperative pain control is obtained with opioid sparing strategies, in order to avoid Post Operative Ileus (POI) and PONV. It is proposed to chew gum three times daily , fluid therapy, early mobilization, early feeding within 2 hours postoperative for at least 15 minutes and eventually to promote a faster bowel function. | Procedure or surgery | ERAS protocol |
Primary outcome
Shorter Length Of Hospitalization (LOH)
Time frame: Up to 4 weeks after surgery
Total amount of days spent in hospital
12 secondary outcomes
Assessment of postoperative pain
Time frame: At moment 24 hours after surgery
Presence/Absence of nausea
Time frame: At moment 0, 3, 6, 12 and 24 hours after surgery
Presence/Absence of vomiting
Time frame: At moment 0, 3, 6, 12 and 24 hours after surgery
Time to flatus
Time frame: Up to 4 weeks after surgery
Time to bowel movement
Time frame: Up to 4 weeks after surgery
Foley catheter removal
Time frame: From 1 to 14days post surgery
Time to drink
Time frame: Up to 4 weeks after surgery
Time to eating
Time frame: Up to 4 weeks after surgery
Time to walking
Time frame: Up to 4 weeks after surgery
Postoperative complications
Time frame: Up to 2 weeks after surgery
Time to adjuvant treatment
Time frame: 60 days
Readmission rates
Time frame: Up to 21 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 25 Apr 2023.
- Derived from this study: PubMed 37138751Xing N, Wang H, Huang Y, Peng J. Enhanced recovery after surgery program alleviates neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio in patients undergoing gynecological surgery. Front Med (Lausanne). 2023 Apr 17;10:1057923. doi: 10.3389/fmed.2023.1057923. eCollection 2023.
- Derived from this study: PubMed 34103993Peng J, Dong R, Jiao J, Liu M, Zhang X, Bu H, Dong P, Zhao S, Xing N, Feng S, Yang X, Kong B. Enhanced Recovery After Surgery Impact on the Systemic Inflammatory Response of Patients Following Gynecological Oncology Surgery: A Prospective Randomized Study. Cancer Manag Res. 2021 Jun 1;13:4383-4392. doi: 10.2147/CMAR.S294718. eCollection 2021.
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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.
Beihua Kong, MD.PhD. principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS protocol in people with Gynecologic Disease and Gynecologic Cancer, run by Shandong University at 1 site in China.
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 4 inclusion and 8 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 25 Apr 2023. 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 China. 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?
Shorter Length Of Hospitalization (LOH) (time frame: Up to 4 weeks after surgery). 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 NCT03629626, 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 25 Apr 2023.