Clinical trial NCT03640299: The Safety and Efficacy of Enhanced Recovery After Surgery on Clinical and Immune Outcomes for Gynecological Oncology
Official title: Shanghai First Maternity and Infant Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecologic Cancer
Keywords: Gynecologic Cancer
Enhanced Recovery After Surgery
Laparoscopic surgery
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total length of hospital stay (days)
timeFrame: Up to 20 days
Secondary outcomes:
measure: Operation Time(h)
timeFrame: The day of surgery
measure: Intraoperative blood loss(mL)
timeFrame: The day of surgery
measure: Intraoperative fluid transfusion units(mL)
timeFrame: The day of surgery
measure: Intraoperative urinary volume(mL)
timeFrame: The day of surgery
measure: Intraoperative blood transfusion(mL)
timeFrame: The day of surgery
measure: Visual Analog Score (VAS) for pain
timeFrame: Up to 5 days after surgery
measure: Post Operative Nausea And Vomiting (PONV) status
timeFrame: Up to 5 days after surgery
measure: Time of off-bed activity per day
timeFrame: 1 week
measure: Distance of off-bed activity per day
timeFrame: 1 week
measure: First exhaust defecation time
timeFrame: Up to 3 days after surgery
measure: Albumin
timeFrame: Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
measure: Prealbumin
timeFrame: Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
measure: WBC
timeFrame: Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
measure: Neutrophil count (NEUT)
timeFrame: Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
measure: C-Reactive Protein (CRP)
timeFrame: Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
measure: CD4+
timeFrame: Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
measure: CD8+
timeFrame: Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
measure: CD4+ / CD8+
timeFrame: Before the operation, on Postoperative Day 1, Postoperative Day 3 and Postoperative Day 5
measure: Hospitalization Expense
timeFrame: Up to 1 month after surgery
measure: Anxiety indicators
timeFrame: Before the operation and Postoperative Day 5
measure: Sleep quality indicators
timeFrame: Before the operation and Postoperative Day 5
measure: Postoperative complications
timeFrame: Up to 1 month after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hospital
state: Shanghai
Study officials:
affiliation: Shanghai First Maternity and Infant Hospital
name: Xiaoqing Guo, Docter
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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(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.
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(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.
citation: Nelson 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.
citation: Chau 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.