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

NCT03640299 | Unknown

• 1 other identifier: ERAS GYNMT LSC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer

Keywords

Gynecologic Cancer; Enhanced Recovery After Surgery; Laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• Total length of hospital stay (days)

  Total length of hospital stay (days)

  Up to 20 days

Secondary Outcomes (22)

• Operation Time(h)

  The day of surgery

• Intraoperative blood loss(mL)

  The day of surgery

• Intraoperative fluid transfusion units(mL)

  The day of surgery

• Intraoperative urinary volume(mL)

  The day of surgery

• Intraoperative blood transfusion(mL)

  The day of surgery

Study Arms (2)

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.

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.

Interventions

ERAS procedure PROCEDURE

Optimized preoperative, intraoperative and postoperative procedures.

ERAS procedure

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai First Maternity and Infant Hospital: lead

Study Sites (1)

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, 201204, China

Location

Related Publications (8)

• 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.

  PMID: 9175983 BACKGROUND

• 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.

  PMID: 26290648 BACKGROUND

• 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.

  PMID: 21597360 BACKGROUND

• 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.

  PMID: 27036606 BACKGROUND

• 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.

  PMID: 26603969 BACKGROUND

• 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.

  PMID: 26757238 BACKGROUND

• 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.

  PMID: 28947172 BACKGROUND

• 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.

  PMID: 35289396 DERIVED

Study Officials

• Xiaoqing Guo, Docter

  Shanghai First Maternity and Infant Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoqing Guo, Docter

CONTACT

+86-18017203488; Xiaoqing_Guo@tongji.edu.cn

Na Liu, Docter

CONTACT

+86-15701745699; Na_Liu@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2018
• First Posted: August 21, 2018
• Study Start: August 30, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 23, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)