Genital Neoplasm Malignant FemaleNCT04201626
Adapted ERAS in Gynecologic Oncology Surgery
A study testing Adapted ERAS in people with Genital Neoplasm Malignant Female, run by Chiang Mai University at 1 site in Thailand.
Trial summary
Background: In recent decades, the new concept of Enhanced Recovery After Surgery (ERAS) program has been well accepted in the fields of gynecologic surgery. Many studies have shown the effectiveness of ERAS protocol in reducing hospital's length of stay, patient's morbidity, and rate of postoperative complications… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Genital Neoplasm Malignant Female
- What is being tested?
- Adapted ERAS
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2020to Feb 2022
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 75 years old
- Diagnosed with gynecologic malignancy of cervix, endometrium, or ovary
- Elective laparotomy surgery
Who cannot join
- Intraoperative accidental injury to urinary or GI organs
- Retain endotracheal intubation after surgery
- Peritoneal drainage for monitoring of bleeding/infection
- Unable to follow oral instructions
- Severe neuromuscular disease
- Preoperative hyperalimentation
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- Neoadjuvant chemotherapy within 3 weeks prior to the procedure
- Previous abdominal/pelvic radiation
- Bowel obstruction
- Emergency operation
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Department of OB-GYN, Faculty of Medicine, Chiang Mai University
Chiang Mai, 50200
Kittipat Charoenkwan, MD, MSc, 66-81-9920845, kittipat.c@cmu.ac.th
Kittipat Charoenkwan, MD, MSc
About this study
Official title: Effectiveness of Adapted Enhanced Recovery After Surgery Protocol in Open Gynecologic Oncology Surgery: A Randomized Controlled Trial
Background: In recent decades, the new concept of Enhanced Recovery After Surgery (ERAS) program has been well accepted in the fields of gynecologic surgery. Many studies have shown the effectiveness of ERAS protocol in reducing hospital's length of stay, patient's morbidity, and rate of postoperative complications while cutting back on health care cost. Thus, standard guidelines such as ACOG has strongly recommended ERAS protocol implementation into each institution. However, institutions have self-limitations on adapting the standard ERAS pathway published from ERAS society due to the demand in resources. The concept of partial implementation of ERAS protocol has been raised and was mentioned in guidelines that ERAS implementation should be individualized to each institution. Nevertheless, the effectiveness of adapted ERAS protocol itself has not been well researched.
Objectives: To examine the effect of partial implementation of ERAS protocol adapted to our institution on patient's recovery (based on hospital length of stay, pain score, time to flatulence, postoperative complications, and re-visits) compared to standard routine care in women diagnosed with gynecologic malignancy (cervix, endometrium, and ovary) undergoing elective open surgery.
Read more
Design: A randomized controlled trial in gynecologic cancers (cervix, endometrium, and ovary) women, age 18-75 years, undergoing elective open gynecologic oncology surgery at Faculty of Medicine, Chiang Mai University hospital. The participants will be randomly assigned into one of two study groups: intervention (adapted ERAS protocol) and control (standard routine care).
For the intervention group, each woman will be brought through the adapted ERAS protocol step by step starting from preoperative counseling and preparation, intraoperative management, and postoperative management standard according to the adapted ERAS protocol. For the control group, each woman will be cared for using routine standard care.
The primary outcome is length of hospital stay.
1.3 Proposed duration 24 Months
- Conditions
- Genital Neoplasm Malignant Female
- Being tested
- Adapted ERAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted ERASProcedure or surgery
Each woman in the intervention group will attend a preoperative counseling session with nurse and doctors. In addition to the standard preoperative counseling, explaining the purpose, process, and the importance of ERAS protocol compliance will be added to the session. Preoperative nutrition and laboratory assessment will be done according to adapted ERAS protocol on that same visit.
During admission, the intervention group participants are provided with care according to adapted ERAS protocol including no bowel preparation, no extended fasting before surgery, balanced intravenous crystalloid, thromboprophylaxis, multimodal pain control reducing opioid usage, multimodal anti-emetics medications, stepping diet up to regular diet within 24 hours, chewing gum for post-operative ileus prevention, early removal of Foley's catheter, and promote early ambulation using care checklist plan.
| Study group | Role | What they receive |
|---|---|---|
| ERAS | Experimental | Not described Receives: Procedure: Adapted ERAS |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Length of hospital stay after surgery
Measured: Through hospital discharge, an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start1 Jun 2020
- Primary completionDec 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Genital Neoplasm Malignant FemaleStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kittipat Charoenkwan, MD, Chiang Mai University
- Investigators
- Kittipat Charoenkwan, MD, MSc, Principal investigator, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201626
- Sponsor's protocol ID
- ERAS_GYNONC 01
- Status last verified
- Jun 2020
- First submitted
- 3 Dec 2019
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chiewhatpong P, Charoenkwan K, Smithiseth K, Lapisatepun W, Lapisatepun P, Phimphilai M, Muangmool T, Cheewakriangkrai C, Suprasert P, Srisomboon J. Effectiveness of enhanced recovery after surgery protocol in open gynecologic oncology surgery: A randomized controlled trial. Int J Gynaecol Obstet. 2022 Nov;159(2):568-576. doi: 10.1002/ijgo.14211. Epub 2022 Apr 21.
PubMed 35396709
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Adapted Enhanced Recovery After Surgery Protocol in Open Gynecologic Oncology Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04201626
- Acronym / sponsor ID
- ERAS_GYNONC 01
- Conditions
- Genital Neoplasm Malignant Female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 17 Dec 2019 (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.
Background: In recent decades, the new concept of Enhanced Recovery After Surgery (ERAS) program has been well accepted in the fields of gynecologic surgery. Many studies have shown the effectiveness of ERAS protocol in reducing hospital's length of stay, patient's morbidity, and rate of postoperative complications while cutting back on health care cost. Thus, standard guidelines such as ACOG has strongly recommended ERAS protocol implementation into each institution. However, institutions have self-limitations on adapting the standard ERAS pathway published from ERAS society due to the demand in resources. The concept of partial implementation of ERAS protocol has been raised and was mentioned in guidelines that ERAS implementation should be individualized to each institution. Nevertheless, the effectiveness of adapted ERAS protocol itself has not been well researched.
Objectives: To examine the effect of partial implementation of ERAS protocol adapted to our institution on patient's recovery (based on hospital length of stay, pain score, time to flatulence, postoperative complications, and re-visits) compared to standard routine care in women diagnosed with gynecologic malignancy (cervix, endometrium, and ovary) undergoing elective open surgery.
Design: A randomized controlled trial in gynecologic cancers (cervix, endometrium, and ovary) women, age 18-75 years, undergoing elective open gynecologic oncology surgery at Faculty of Medicine, Chiang Mai University hospital. The participants will be randomly assigned into one of two study groups: intervention (adapted ERAS protocol) and control (standard routine care).
For the intervention group, each woman will be brought through the adapted ERAS protocol step by step starting from preoperative counseling and preparation, intraoperative management, and postoperative management standard according to the adapted ERAS protocol. For the control group, each woman will be cared for using routine standard care.
The primary outcome is length of hospital stay.
1.3 Proposed duration 24 Months
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS | Experimental | Procedure: Adapted ERAS |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 - 75 years old
- Diagnosed with gynecologic malignancy of cervix, endometrium, or ovary
- Elective laparotomy surgery
Key exclusion criteria (10 listed)
- Intraoperative accidental injury to urinary or GI organs
- Retain endotracheal intubation after surgery
- Peritoneal drainage for monitoring of bleeding/infection
- Unable to follow oral instructions
- Severe neuromuscular disease
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 |
|---|---|---|
| Adapted ERASEach woman in the intervention group will attend a preoperative counseling session with nurse and doctors. In addition to the standard preoperative counseling, explaining the purpose, process, and the importance of ERAS protocol compliance will be added to the session. Preoperative nutrition and laboratory assessment will be done according to adapted ERAS protocol on that same visit. During admission, the intervention group participants are provided with care according to adapted ERAS protocol including no bowel preparation, no extended fasting before surgery, balanced intravenous crystalloid, thromboprophylaxis, multimodal pain control reducing opioid usage, multimodal anti-emetics medications, stepping diet up to regular diet within 24 hours, chewing gum for post-operative ileus prevention, early removal of Foley's catheter, and promote early ambulation using care checklist plan. | Procedure or surgery | ERAS |
Primary outcome
Length of hospital stay
Time frame: Through hospital discharge, an average of 5 days
Length of hospital stay after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Derived from this study: PubMed 35396709Chiewhatpong P, Charoenkwan K, Smithiseth K, Lapisatepun W, Lapisatepun P, Phimphilai M, Muangmool T, Cheewakriangkrai C, Suprasert P, Srisomboon J. Effectiveness of enhanced recovery after surgery protocol in open gynecologic oncology surgery: A randomized controlled trial. Int J Gynaecol Obstet. 2022 Nov;159(2):568-576. doi: 10.1002/ijgo.14211. Epub 2022 Apr 21.
- Individual participant dataSharing planned: No
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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.
Kittipat Charoenkwan, MD, MSc principal investigator
Chiang Mai 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 Adapted ERAS in people with Genital Neoplasm Malignant Female, run by Chiang Mai University at 1 site in Thailand.
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 10 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: status not confirmed, as of the sponsor's last update on 29 Jun 2020. 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kittipat Charoenkwan, MD, MSc (+66-81-9920845, kittipat.c@cmu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: Through hospital discharge, an average of 5 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 NCT04201626, which also lists 1 linked publication.
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 29 Jun 2020.