Early Discharge After Colorectal Surgery (RECUPERA-C)
RECUPERA-C Study: Protocol: Personalised and Controlled Rapid Recovery After Colorectal Surgery
調査の概要
詳細な説明
RECUPERA-C is a prospective observational cohort study conducted within an established Enhanced Recovery After Surgery (ERAS) program. The study will include adult patients undergoing elective major colorectal surgery through a minimally invasive approach.
The study will evaluate a structured early discharge protocol based on predefined clinical and functional criteria. Patients will be assessed during the first 48 hours after surgery to determine whether they meet the conditions considered necessary for safe discharge. These criteria include clinical stability, adequate pain and nausea control, oral intake, gastrointestinal recovery, and functional recovery.
Patients will be followed prospectively for 30 days after surgery. The study will evaluate the proportion of patients meeting the early discharge criteria, the actual early discharge rate, reasons for prolonged hospitalisation, total length of stay, postoperative complications, readmissions, healthcare resource utilisation, and patient satisfaction.
C-reactive protein and neutrophil-to-lymphocyte ratio will be collected as exploratory biomarkers to assess their potential association with postoperative complications and their possible role as complementary tools for risk stratification.
The study will also identify clinical, functional, social, and organisational factors that may limit implementation of the early discharge strategy. The overall aim is to determine whether a structured discharge pathway within an ERAS programme can safely and feasibly reduce hospital stay to 48 hours or less after minimally invasive colorectal surgery.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Julieta Puente-Monserrat, MD
- 電話番号:+34628370371
- メール:juliethpuente27@gmail.com
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Age ≥18 years.
- Elective major colorectal surgery for benign or malignant disease.
- Minimally invasive approach (laparoscopic or robotic).
- ASA physical status I-III.
- Functional independence in basic activities of daily living.
- Adequate home support and the ability to access and return to the hospital if required.
- Adequate understanding of the perioperative plan.
- Written informed consent.
Exclusion Criteria:
- Emergency surgery.
- Significant intraoperative complications.
- Major multivisceral resections.
- New ostomy creation.
- Functional dependence or significant cognitive impairment.
- Decompensation of major comorbidities.
- Anticipated need for postoperative admission to an intensive care unit.
- Social circumstances that may make early discharge unsafe.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
Colorectal Surgery Patients
Adult patients undergoing elective major minimally invasive colorectal surgery.
A structured early discharge pathway (≤48 hours) will be applied based on predefined clinical and functional criteria.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of patients fulfilling all predefined clinical and functional criteria for early discharge (≤48 hours after surgery)
時間枠:Within 48 hours after surgery
|
Proportion of patients fulfilling all predefined clinical and functional criteria for early discharge (≤48 hours after surgery)
|
Within 48 hours after surgery
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Cook EJ, Walsh SR, Farooq N, Alberts JC, Justin TA, Keeling NJ. Post-operative neutrophil-lymphocyte ratio predicts complications following colorectal surgery. Int J Surg. 2007 Feb;5(1):27-30. doi: 10.1016/j.ijsu.2006.05.013. Epub 2006 Jun 27.
- Chung F, Chan VW, Ong D. A post-anesthetic discharge scoring system for home readiness after ambulatory surgery. J Clin Anesth. 1995 Sep;7(6):500-6. doi: 10.1016/0952-8180(95)00130-a.
- Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.
- Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
- Jayne D, Pigazzi A, Marshall H, Croft J, Corrigan N, Copeland J, Quirke P, West N, Rautio T, Thomassen N, Tilney H, Gudgeon M, Bianchi PP, Edlin R, Hulme C, Brown J. Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial. JAMA. 2017 Oct 24;318(16):1569-1580. doi: 10.1001/jama.2017.7219.
- Veldkamp R, Kuhry E, Hop WC, Jeekel J, Kazemier G, Bonjer HJ, Haglind E, Pahlman L, Cuesta MA, Msika S, Morino M, Lacy AM; COlon cancer Laparoscopic or Open Resection Study Group (COLOR). Laparoscopic surgery versus open surgery for colon cancer: short-term outcomes of a randomised trial. Lancet Oncol. 2005 Jul;6(7):477-84. doi: 10.1016/S1470-2045(05)70221-7.
- Alsharqawi N, Alhashemi M, Kaneva P, Baldini G, Fiore JF Jr, Feldman LS, Lee L. Validity of the I-FEED score for postoperative gastrointestinal function in patients undergoing colorectal surgery. Surg Endosc. 2020 May;34(5):2219-2226. doi: 10.1007/s00464-019-07011-6. Epub 2019 Jul 30.
- Pajaron-Guerrero M, Fernandez-Miera MF, Duenas-Puebla JC, Cagigas-Fernandez C, Allende-Mancisidor I, Cristobal-Poch L, Gomez-Fleitas M, Manzano-Peral MA, Gonzalez-Fernandez CR, Aguilera-Zubizarreta A, Sanroma-Mendizabal P; Hospital Valdecilla ERAS Study Group. Early Discharge Programme on Hospital-at-Home Evaluation for Patients with Immediate Postoperative Course after Laparoscopic Colorectal Surgery. Eur Surg Res. 2017;58(5-6):263-273. doi: 10.1159/000479004. Epub 2017 Aug 9.
- van Outersterp L, Laurijs SHH, Amraoui YE, Peeters AE, Verdaasdonk EEG. Monitoring early discharge after laparoscopic colon surgery: an interventional study. Surg Endosc. 2025 Jun;39(6):3654-3661. doi: 10.1007/s00464-025-11716-2. Epub 2025 Apr 29.
- Leenen JPL, Ardesch V, Patijn G. Remote Home Monitoring of Continuous Vital Sign Measurements by Wearables in Patients Discharged After Colorectal Surgery: Observational Feasibility Study. JMIR Perioper Med. 2023 May 5;6:e45113. doi: 10.2196/45113.
- Dos Santos BDN, Beruti C, Azevedo J, Herrando I, Vieira P, Domingos H, Heald R, Fernandez L, Parvaiz A. Using inflammatory parameters for safe and early discharge after minimally invasive colorectal surgery for colorectal cancer. Tech Coloproctol. 2025 Apr 7;29(1):97. doi: 10.1007/s10151-025-03134-2.
- Adamina M, Warschkow R, Naf F, Hummel B, Rduch T, Lange J, Steffen T. Monitoring c-reactive protein after laparoscopic colorectal surgery excludes infectious complications and allows for safe and early discharge. Surg Endosc. 2014 Oct;28(10):2939-48. doi: 10.1007/s00464-014-3556-0. Epub 2014 May 23.
- Warschkow R, Beutner U, Steffen T, Muller SA, Schmied BM, Guller U, Tarantino I. Safe and early discharge after colorectal surgery due to C-reactive protein: a diagnostic meta-analysis of 1832 patients. Ann Surg. 2012 Aug;256(2):245-50. doi: 10.1097/SLA.0b013e31825b60f0.
- Buscail E, Duchalais E. Unplanned re-hospitalizations after colorectal surgery. J Visc Surg. 2025 Aug;162(4S):S39-S45. doi: 10.1016/j.jviscsurg.2025.06.009. Epub 2025 Aug 5.
- McLemore EC, Lee L, Hedrick TL, Rashidi L, Askenasy EP, Popowich D, Sylla P. Same day discharge following elective, minimally invasive, colorectal surgery : A review of enhanced recovery protocols and early outcomes by the SAGES Colorectal Surgical Committee with recommendations regarding patient selection, remote monitoring, and successful implementation. Surg Endosc. 2022 Nov;36(11):7898-7914. doi: 10.1007/s00464-022-09606-y. Epub 2022 Sep 21.
- Yu ZH, Wang LM, Chan LY, You JF, Lin GP. Accelerated enhanced recovery after colorectal surgery with early discharge: A systematic review and meta-analysis. Langenbecks Arch Surg. 2026 Feb 27;411(1):104. doi: 10.1007/s00423-026-03977-9.
- Tavernier C, Flaris AN, Passot G, Glehen O, Kepenekian V, Cotte E. Assessing Criteria for a Safe Early Discharge After Laparoscopic Colorectal Surgery. JAMA Surg. 2022 Jan 1;157(1):52-58. doi: 10.1001/jamasurg.2021.5551.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- RECUPERA-C
- 2025/431 (その他の識別子:Comité de Ética de la Investigación con medicamentos (CEIm) del Hospital Clínico Universitario de Valencia)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。