Gynecologic CancerNCT03640299
The Safety and Efficacy of Enhanced Recovery After Surgery on Clinical and Immune Outcomes for Gynecological Oncology
A study testing ERAS procedure in people with Gynecologic Cancer, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
Trial summary
The aim of this study is to compare outcomes of enhanced recovery after surgery (ERAS) procedure, involving preoperative, intraoperative and postoperative optimization, with those of conventional treatment procedure in women undergoing laparoscopic surgery for gynecologic cancer or suspected gynecologic cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- ERAS procedure
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 30 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
- Newly pathological diagnosed and suspected gynecologic tumors, including cervical cancer, ovarian cancer, endometrial cancer, fallopian tube cancer, uterine carcinosarcoma, and choriocarcinoma.
- Ages range from 18 to 70.
- body mass index of between 18 and 35.
- American Society of Anesthesiologists (ASA) grading of I to III.
- No history of abdominal surgery and severe organ dysfunction such as heart and lung.
Who cannot join
- Unwillingness to participate.
- Inability to give written informed consent.
- Absolute contraindication for surgery.
- History of other malignancies, radiotherapy and chemotherapy.
- Uncontrollable Cardiovascular and cerebrovascular diseases, diabetes, and liver and kidney dysfunction.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, 201204
Xiaoqing Guo, Doctor, +86-181117203488, Xiaoqing_Guo@tongji.edu.cn
Na Liu, Doctor, +87-15601745699, Na_Liu@tongji.edu.cn
About this study
Official title: Shanghai First Maternity and Infant Hospital
The aim of this study is to compare outcomes of enhanced recovery after surgery (ERAS) procedure, involving preoperative, intraoperative and postoperative optimization, with those of conventional treatment procedure in women undergoing laparoscopic surgery for gynecologic cancer or suspected gynecologic cancer. Investigators hypothesize that those patients randomized to the ERAS protocol will have better recovery status, shorter lengths of hospital stay, without increasing readmission rates and complications, compared with traditional treatment.
Read the detailed description
Over the past two decades, enhanced recovery after surgery (ERAS) has been initiated and developed in colorectal surgery by Kehlet. Studies have demonstrated that ERAS program can reduce length of hospital stay, hospital cost, complications and morbidity and improve the quality of patient recovery in colorectal, urologic, thoracic, orthopedic, and vascular surgeries by randomized trials and meta-analyses. However, the data in gynecologic oncology underwent minimally invasive therapy is scarce. Therefore, the aim of this study is compare outcomes of ERAS procedure with conventional treatment procedure, to provide practical experience and guidance for the treatment of gynecologic cancer in the future.
The study is a single-center randomized control trial (RCT), and 80 cases of gynecological malignancy in Shanghai First Maternity and Infant Hospital from 2018 to 2021 will be enrolled in this research. All patients with a known or suspected gynecologic malignancy scheduled for laparoscopic surgery will be screened for study eligibility. Those eligible for the study will be approached for participation in the study and provided written informed consent. The randomization sequence of group allocation by means of computer-generated random numbers was generated by an independent statistician from Tongji University.
For ERAS group, patients would receive an optimized preoperative, intraoperative and postoperative care, including extensive preoperative counselling, no mechanical bowel preparation, nonselective NSAIDs premedication, no preoperative fasting but with preoperative carbohydrate loading, tailored anaesthesiology, non-opioid pain management, early removal of urinary catheter, early postoperative feeding and mobilization, and postoperative antiemetic and analgesia management. For control group, patients would receive standard conventional procedure. After meeting the discharge criteria, patients would discharge and additionally follow-up in gynecologic oncology clinic at 2 weeks and 6 weeks postoperatively.
Primary outcome measure of the study involves operation length(h), intraoperative blood loss(mL), intraoperative fluid transfusion units(mL), intraoperative urinary volume(mL), intraoperative blood transfusion(mL), postoperative vital signs, Visual Analog Score (VAS) scale, Post Operative Nausea And Vomiting (PONV) status, first exhaust defecation time, ambulation, length of stay, hospitalization expense, albumin and prealbumin, and postoperative complications. Apart from clinical outcomes, the immunological indicators will also be assessed, consist of WBC, neutrophil count (NEUT), C-Reactive Protein (CRP), CD3+ T cells, CD4+ T cells, CD8+ T cells, CD4+/CD8+ T cells preoperatively, and on post-operative day 1(POD1), POD3, POD5. In addition, the anxiety and sleep quality indicators were analyzed by questionnaire preoperatively and POD5.
For statistical analyses, categorical variables were described using counts and frequencies, and quantitative variables were described using mean, medians and ranges. Patients' characteristics and distribution were compared with MannWhitney U and χ2 tests. The level of statistical significance was set at P< 0.05. Statistical analyses were carried out with the SPSS 20.0.
- Conditions
- Gynecologic Cancer
- Being tested
- ERAS procedure
- Keywords
- Gynecologic Cancer, Enhanced Recovery After Surgery, Laparoscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS procedureProcedure or surgery
Optimized preoperative, intraoperative and postoperative procedures.
| Study group | Role | What they receive |
|---|---|---|
| ERAS procedure | Experimental | In this arm, ERAS perioperative cares patients planned to undergoing laparoscopic surgery, following the ERAS protocols.
Extensive preoperative counselling and education by surgeon and anesthetists.
No Bowel preparation.
6 h fast for solid food and carbohydrate loading with clear fuilds 2h before surgery.
Oral nonselective NSAIDs premedication.
Total Intravenous Anesthesia via TCI, wound infiltration and the transversus abdominis plane (TAP).
Minimally invasive surgery.
Maintenance of normothermia.
Avoidance of surgical drains and nasogastric tubes.
Nonselective NSAIDs postoperative medication.
Postoperative nausea and vomiting active control.
Early oral feeding and ambulation.
VTE prophylaxis postoperative. Receives: Procedure: ERAS procedure |
| Traditional treatment procedure | No intervention | In this arm, control patients planned to undergoing laparoscopic surgery, following the traditional treatment protocols. Conventional preoperative visits and education. Mechanical bowel preparation. Fasting overnight, and no fluids before surgery. No oral nonselective NSAIDs premedication. Continuous epidural anesthesia is administered before surgery. Sevoflurane and sufentanil maintain the depth of anesthesia. Minimally invasive surgery. No maintenance of normothermia. Drainage tube insertion if needed. Postoperative patient-controlled intravenous analgesia. Postoperative Nausea Control if needed. Conventional oral feeding and mobilization. No bowel routine. VTE prophylaxis postoperative. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total length of hospital stay (days)
Total length of hospital stay (days)
Measured: Up to 20 days
Secondary outcomes (22)
Operation Time(h)
Operation Time(h)
Measured: The day of surgery
Intraoperative blood loss(mL)
Blood loss during the operation
Measured: The day of surgery
Intraoperative fluid transfusion units(mL)
Fluid transfusion units during the operation
Measured: The day of surgery
Intraoperative urinary volume(mL)
Urinary volume during the operation
Measured: The day of surgery
Intraoperative blood transfusion(mL)
Urinary volume during the operation
Measured: The day of surgery
Visual Analog Score (VAS) for pain
Visual Analog Score (VAS) for pain
Measured: Up to 5 days after surgery
Post Operative Nausea And Vomiting (PONV) status
Post Operative Nausea And Vomiting (PONV) status
Measured: Up to 5 days after surgery
Time of off-bed activity per day
Postoperative activity
Measured: 1 week
Distance of off-bed activity per day
Postoperative activity
Measured: 1 week
First exhaust defecation time
Bowel function recovery
Measured: Up to 3 days after surgery
Albumin
Nutritional indicators
Measured: Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
Prealbumin
Nutritional indicators
Measured: Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
WBC
Immunological indicators
Measured: Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
Neutrophil count (NEUT)
Immunological indicators
Measured: Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
C-Reactive Protein (CRP)
Immunological indicators
Measured: Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
CD4+
Immunological indicators
Measured: Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
CD8+
Immunological indicators
Measured: Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
CD4+ / CD8+
Immunological indicators
Measured: Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
Hospitalization Expense
Medical expense
Measured: Up to 1 month after surgery
Anxiety indicators
Anxiety index were tested by questionnaire of self-rating anxiety scale(SAS) on preoperation and Postoperative Day 5
Measured: Before the operation and Postoperative Day 5
Sleep quality indicators
Sleep quality index were tested by questionnaire of Pittsburgh sleep quality index(PSQI) on preoperation and Postoperative Day 5
Measured: Before the operation and Postoperative Day 5
Postoperative complications
Postoperative complications
Measured: Up to 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start30 Aug 2018 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Gynecologic CancerStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoqing Guo, Docter, Principal investigator, Shanghai First Maternity and Infant Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640299
- Sponsor's protocol ID
- ERAS GYNMT LSC
- Status last verified
- Aug 2018
- First submitted
- 8 Jul 2018
- Last updated
- 23 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. doi: 10.1093/bja/78.5.606.
PubMed 9175983Ni TG, Yang HT, Zhang H, Meng HP, Li B. Enhanced recovery after surgery programs in patients undergoing hepatectomy: A meta-analysis. World J Gastroenterol. 2015 Aug 14;21(30):9209-16. doi: 10.3748/wjg.v21.i30.9209.
PubMed 26290648Vlug MS, Wind J, Hollmann MW, Ubbink DT, Cense HA, Engel AF, Gerhards MF, van Wagensveld BA, van der Zaag ES, van Geloven AA, Sprangers MA, Cuesta MA, Bemelman WA; LAFA study group. Laparoscopy in combination with fast track multimodal management is the best perioperative strategy in patients undergoing colonic surgery: a randomized clinical trial (LAFA-study). Ann Surg. 2011 Dec;254(6):868-75. doi: 10.1097/SLA.0b013e31821fd1ce.
PubMed 21597360Wainwright TW, Immins T, Middleton RG. Enhanced recovery after surgery (ERAS) and its applicability for major spine surgery. Best Pract Res Clin Anaesthesiol. 2016 Mar;30(1):91-102. doi: 10.1016/j.bpa.2015.11.001. Epub 2015 Nov 23.
PubMed 27036606Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for pre- and intra-operative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part I. Gynecol Oncol. 2016 Feb;140(2):313-22. doi: 10.1016/j.ygyno.2015.11.015. Epub 2015 Nov 18. No abstract available.
PubMed 26603969Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3. No abstract available.
PubMed 26757238Nelson G, Dowdy SC, Lasala J, Mena G, Bakkum-Gamez J, Meyer LA, Iniesta MD, Ramirez PT. Enhanced recovery after surgery (ERAS(R)) in gynecologic oncology - Practical considerations for program development. Gynecol Oncol. 2017 Dec;147(3):617-620. doi: 10.1016/j.ygyno.2017.09.023. Epub 2017 Sep 23. No abstract available.
PubMed 28947172Chau JPC, Liu X, Lo SHS, Chien WT, Hui SK, Choi KC, Zhao J. Perioperative enhanced recovery programmes for women with gynaecological cancers. Cochrane Database Syst Rev. 2022 Mar 15;3(3):CD008239. doi: 10.1002/14651858.CD008239.pub5.
PubMed 35289396
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai First Maternity and Infant Hospital
- ClinicalTrials.gov ID
- NCT03640299
- Acronym / sponsor ID
- ERAS GYNMT LSC
- Conditions
- Gynecologic Cancer
- Keywords
- Gynecologic Cancer, Enhanced Recovery After Surgery, Laparoscopic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- 30 Aug 2018 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 21 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.
The aim of this study is to compare outcomes of enhanced recovery after surgery (ERAS) procedure, involving preoperative, intraoperative and postoperative optimization, with those of conventional treatment procedure in women undergoing laparoscopic surgery for gynecologic cancer or suspected gynecologic cancer. Investigators hypothesize that those patients randomized to the ERAS protocol will have better recovery status, shorter lengths of hospital stay, without increasing readmission rates and complications, compared with traditional treatment.
Detailed description
Over the past two decades, enhanced recovery after surgery (ERAS) has been initiated and developed in colorectal surgery by Kehlet. Studies have demonstrated that ERAS program can reduce length of hospital stay, hospital cost, complications and morbidity and improve the quality of patient recovery in colorectal, urologic, thoracic, orthopedic, and vascular surgeries by randomized trials and meta-analyses. However, the data in gynecologic oncology underwent minimally invasive therapy is scarce. Therefore, the aim of this study is compare outcomes of ERAS procedure with conventional treatment procedure, to provide practical experience and guidance for the treatment of gynecologic cancer in the future.
The study is a single-center randomized control trial (RCT), and 80 cases of gynecological malignancy in Shanghai First Maternity and Infant Hospital from 2018 to 2021 will be enrolled in this research. All patients with a known or suspected gynecologic malignancy scheduled for laparoscopic surgery will be screened for study eligibility. Those eligible for the study will be approached for participation in the study and provided written informed consent. The randomization sequence of group allocation by means of computer-generated random numbers was generated by an independent statistician from Tongji University.
For ERAS group, patients would receive an optimized preoperative, intraoperative and postoperative care, including extensive preoperative counselling, no mechanical bowel preparation, nonselective NSAIDs premedication, no preoperative fasting but with preoperative carbohydrate loading, tailored anaesthesiology, non-opioid pain management, early removal of urinary catheter, early postoperative feeding and mobilization, and postoperative antiemetic and analgesia management. For control group, patients would receive standard conventional procedure. After meeting the discharge criteria, patients would discharge and additionally follow-up in gynecologic oncology clinic at 2 weeks and 6 weeks postoperatively.
Primary outcome measure of the study involves operation length(h), intraoperative blood loss(mL), intraoperative fluid transfusion units(mL), intraoperative urinary volume(mL), intraoperative blood transfusion(mL), postoperative vital signs, Visual Analog Score (VAS) scale, Post Operative Nausea And Vomiting (PONV) status, first exhaust defecation time, ambulation, length of stay, hospitalization expense, albumin and prealbumin, and postoperative complications. Apart from clinical outcomes, the immunological indicators will also be assessed, consist of WBC, neutrophil count (NEUT), C-Reactive Protein (CRP), CD3+ T cells, CD4+ T cells, CD8+ T cells, CD4+/CD8+ T cells preoperatively, and on post-operative day 1(POD1), POD3, POD5. In addition, the anxiety and sleep quality indicators were analyzed by questionnaire preoperatively and POD5.
For statistical analyses, categorical variables were described using counts and frequencies, and quantitative variables were described using mean, medians and ranges. Patients' characteristics and distribution were compared with MannWhitney U and χ2 tests. The level of statistical significance was set at P< 0.05. Statistical analyses were carried out with the SPSS 20.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS procedure | Experimental | Procedure: ERAS procedureIn this arm, ERAS perioperative cares patients planned to undergoing laparoscopic surgery, following the ERAS protocols. Extensive preoperative counselling and education by surgeon and anesthetists. No Bowel preparation. 6 h fast for solid food and carbohydrate loading with clear fuilds 2h before surgery. Oral nonselective NSAIDs premedication. Total Intravenous Anesthesia via TCI, wound infiltration and the transversus abdominis plane (TAP). Minimally invasive surgery. Maintenance of normothermia. Avoidance of surgical drains and nasogastric tubes. Nonselective NSAIDs postoperative medication. Postoperative nausea and vomiting active control. Early oral feeding and ambulation. VTE prophylaxis postoperative. |
| Traditional treatment procedure | No intervention | –In this arm, control patients planned to undergoing laparoscopic surgery, following the traditional treatment protocols. Conventional preoperative visits and education. Mechanical bowel preparation. Fasting overnight, and no fluids before surgery. No oral nonselective NSAIDs premedication. Continuous epidural anesthesia is administered before surgery. Sevoflurane and sufentanil maintain the depth of anesthesia. Minimally invasive surgery. No maintenance of normothermia. Drainage tube insertion if needed. Postoperative patient-controlled intravenous analgesia. Postoperative Nausea Control if needed. Conventional oral feeding and mobilization. No bowel routine. VTE prophylaxis postoperative. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly pathological diagnosed and suspected gynecologic tumors, including cervical cancer, ovarian cancer, endometrial cancer, fallopian tube cancer, uterine carcinosarcoma, and choriocarcinoma.
- Ages range from 18 to 70.
- body mass index of between 18 and 35.
- American Society of Anesthesiologists (ASA) grading of I to III.
- No history of abdominal surgery and severe organ dysfunction such as heart and lung.
Key exclusion criteria (5 listed)
- Unwillingness to participate.
- Inability to give written informed consent.
- Absolute contraindication for surgery.
- History of other malignancies, radiotherapy and chemotherapy.
- Uncontrollable Cardiovascular and cerebrovascular diseases, diabetes, and liver and kidney dysfunction.
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 procedureOptimized preoperative, intraoperative and postoperative procedures. | Procedure or surgery | ERAS procedure |
Primary outcome
Total length of hospital stay (days)
Time frame: Up to 20 days
Total length of hospital stay (days)
22 secondary outcomes
Operation Time(h)
Time frame: The day of surgery
Intraoperative blood loss(mL)
Time frame: The day of surgery
Intraoperative fluid transfusion units(mL)
Time frame: The day of surgery
Intraoperative urinary volume(mL)
Time frame: The day of surgery
Intraoperative blood transfusion(mL)
Time frame: The day of surgery
Visual Analog Score (VAS) for pain
Time frame: Up to 5 days after surgery
Post Operative Nausea And Vomiting (PONV) status
Time frame: Up to 5 days after surgery
Time of off-bed activity per day
Time frame: 1 week
Distance of off-bed activity per day
Time frame: 1 week
First exhaust defecation time
Time frame: Up to 3 days after surgery
Albumin
Time frame: Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
Prealbumin
Time frame: Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
WBC
Time frame: Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
Neutrophil count (NEUT)
Time frame: Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
C-Reactive Protein (CRP)
Time frame: Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
CD4+
Time frame: Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
CD8+
Time frame: Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
CD4+ / CD8+
Time frame: Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
Hospitalization Expense
Time frame: Up to 1 month after surgery
Anxiety indicators
Time frame: Before the operation and Postoperative Day 5
Sleep quality indicators
Time frame: Before the operation and Postoperative Day 5
Postoperative complications
Time frame: Up to 1 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Background: PubMed 9175983Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. doi: 10.1093/bja/78.5.606.
- Background: PubMed 26290648Ni TG, Yang HT, Zhang H, Meng HP, Li B. Enhanced recovery after surgery programs in patients undergoing hepatectomy: A meta-analysis. World J Gastroenterol. 2015 Aug 14;21(30):9209-16. doi: 10.3748/wjg.v21.i30.9209.
- Background: PubMed 21597360Vlug MS, Wind J, Hollmann MW, Ubbink DT, Cense HA, Engel AF, Gerhards MF, van Wagensveld BA, van der Zaag ES, van Geloven AA, Sprangers MA, Cuesta MA, Bemelman WA; LAFA study group. Laparoscopy in combination with fast track multimodal management is the best perioperative strategy in patients undergoing colonic surgery: a randomized clinical trial (LAFA-study). Ann Surg. 2011 Dec;254(6):868-75. doi: 10.1097/SLA.0b013e31821fd1ce.
- Background: PubMed 27036606Wainwright TW, Immins T, Middleton RG. Enhanced recovery after surgery (ERAS) and its applicability for major spine surgery. Best Pract Res Clin Anaesthesiol. 2016 Mar;30(1):91-102. doi: 10.1016/j.bpa.2015.11.001. Epub 2015 Nov 23.
- Background: PubMed 26603969Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for pre- and intra-operative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part I. Gynecol Oncol. 2016 Feb;140(2):313-22. doi: 10.1016/j.ygyno.2015.11.015. Epub 2015 Nov 18. No abstract available.
- Background: PubMed 26757238Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3. No abstract available.
- Background: PubMed 28947172Nelson G, Dowdy SC, Lasala J, Mena G, Bakkum-Gamez J, Meyer LA, Iniesta MD, Ramirez PT. Enhanced recovery after surgery (ERAS(R)) in gynecologic oncology - Practical considerations for program development. Gynecol Oncol. 2017 Dec;147(3):617-620. doi: 10.1016/j.ygyno.2017.09.023. Epub 2017 Sep 23. No abstract available.
- Derived from this study: PubMed 35289396Chau JPC, Liu X, Lo SHS, Chien WT, Hui SK, Choi KC, Zhao J. Perioperative enhanced recovery programmes for women with gynaecological cancers. Cochrane Database Syst Rev. 2022 Mar 15;3(3):CD008239. doi: 10.1002/14651858.CD008239.pub5.
- 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.
Xiaoqing Guo, Docter principal investigator
Shanghai First Maternity and Infant Hospital
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 procedure in people with Gynecologic Cancer, run by Shanghai First Maternity and Infant Hospital 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 5 inclusion and 5 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 23 Aug 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoqing Guo, Docter (+86-18017203488, Xiaoqing_Guo@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total length of hospital stay (days) (time frame: Up to 20 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 NCT03640299, which also lists 8 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 23 Aug 2018.