- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07827378
Early Discharge After Colorectal Surgery (RECUPERA-C)
RECUPERA-C Study: Protocol: Personalised and Controlled Rapid Recovery After Colorectal Surgery
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Julieta Puente-Monserrat, MD
- 전화번호: +34628370371
- 이메일: juliethpuente27@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of patients fulfilling all predefined clinical and functional criteria for early discharge (≤48 hours after surgery)
기간: Within 48 hours after surgery
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Proportion of patients fulfilling all predefined clinical and functional criteria for early discharge (≤48 hours after surgery)
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Within 48 hours after surgery
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- RECUPERA-C
- 2025/431 (기타 식별자: Comité de Ética de la Investigación con medicamentos (CEIm) del Hospital Clínico Universitario de Valencia)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .