Clinical trial · Interventional
The Safety and Efficacy of Enhanced Recovery After Surgery on Clinical and Immune Outcomes for Gynecological Oncology
Shanghai First Maternity and Infant Hospital
NCT03640299CI-TRIAL-00034527unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ERAS procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ERAS procedure
- description
- 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.
- interventionNames
- Procedure: ERAS procedure
- type
- NO_INTERVENTION
- label
- Traditional treatment procedure
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (8)
- BACKGROUNDKehlet 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
- BACKGROUNDNi 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
- BACKGROUNDVlug 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
- BACKGROUNDWainwright 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
- BACKGROUNDNelson 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
- BACKGROUNDNelson 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.