The Safety and Efficacy of Enhanced Recovery After Surgery on Clinical and Immune Outcomes for Gynecological Oncology

Gynecologic Cancer Clinical Trial

Official title:

Shanghai First Maternity and Infant Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03640299
• Other study ID #: ERAS GYNMT LSC
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 30, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2018
• Source: Shanghai First Maternity and Infant Hospital
• Contact: Xiaoqing Guo, Docter
• Phone: +86-18017203488
• Email: Xiaoqing_Guo[@]tongji.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

Procedure:
• ERAS procedure
Optimized preoperative, intraoperative and postoperative procedures.

Locations

Country	Name	City	State
China	Shanghai First Maternity and Infant Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai First Maternity and Infant Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. Review. — View Citation

Nelson 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®) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3. — View Citation

Nelson 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®) Society recommendations--Part I. Gynecol Oncol. 2016 Feb;140(2):313-22. doi: 10.1016/j.ygyno.2015.11.015. Epub 2015 Nov 18. — View Citation

Nelson G, Dowdy SC, Lasala J, Mena G, Bakkum-Gamez J, Meyer LA, Iniesta MD, Ramirez PT. Enhanced recovery after surgery (ERAS®) 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. — View Citation

Ni 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. Review. — View Citation

Vlug 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. — View Citation

Wainwright 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total length of hospital stay (days)	Total length of hospital stay (days)	Up to 20 days
Secondary	Operation Time(h)	Operation Time(h)	The day of surgery
Secondary	Intraoperative blood loss(mL)	Blood loss during the operation	The day of surgery
Secondary	Intraoperative fluid transfusion units(mL)	Fluid transfusion units during the operation	The day of surgery
Secondary	Intraoperative urinary volume(mL)	Urinary volume during the operation	The day of surgery
Secondary	Intraoperative blood transfusion(mL)	Urinary volume during the operation	The day of surgery
Secondary	Visual Analog Score (VAS) for pain	Visual Analog Score (VAS) for pain	Up to 5 days after surgery
Secondary	Post Operative Nausea And Vomiting (PONV) status	Post Operative Nausea And Vomiting (PONV) status	Up to 5 days after surgery
Secondary	Time of off-bed activity per day	Postoperative activity	1 week
Secondary	Distance of off-bed activity per day	Postoperative activity	1 week
Secondary	First exhaust defecation time	Bowel function recovery	Up to 3 days after surgery
Secondary	Albumin	Nutritional indicators	Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
Secondary	Prealbumin	Nutritional indicators	Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
Secondary	WBC	Immunological indicators	Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
Secondary	Neutrophil count (NEUT)	Immunological indicators	Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
Secondary	C-Reactive Protein (CRP)	Immunological indicators	Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
Secondary	CD4+	Immunological indicators	Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
Secondary	CD8+	Immunological indicators	Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
Secondary	CD4+ / CD8+	Immunological indicators	Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
Secondary	Hospitalization Expense	Medical expense	Up to 1 month after surgery
Secondary	Anxiety indicators	Anxiety index were tested by questionnaire of self-rating anxiety scale(SAS) on preoperation and Postoperative Day 5	Before the operation and Postoperative Day 5
Secondary	Sleep quality indicators	Sleep quality index were tested by questionnaire of Pittsburgh sleep quality index(PSQI) on preoperation and Postoperative Day 5	Before the operation and Postoperative Day 5
Secondary	Postoperative complications	Postoperative complications	Up to 1 month after surgery