Enhanced Recovery Versus Standard Care After Emergency Abdominal Surgery in Patients Requiring Emergency Laparotomy
Comparison of Enhanced Recovery Protocol After Surgery Versus Conventional Care in Emergency Laparotomy
This study aims to compare an Enhanced Recovery After Surgery (ERAS) protocol with conventional postoperative care in adults undergoing emergency laparotomy for intestinal obstruction or intestinal perforation.
The main question this study aims to answer is:
• Does the ERAS protocol reduce surgical site infections compared with conventional care after emergency laparotomy?
Researchers will also compare other recovery outcomes between the two groups, including length of hospital stay, occurrence of paralytic ileus (temporary loss of bowel function), time to first bowel movement, and time to start taking fluids by mouth after surgery.
A total of 102 participants will be enrolled and randomly assigned to one of two groups. One group will receive postoperative care according to the ERAS protocol, while the other group will receive conventional postoperative care. All participants will undergo emergency laparotomy using standard surgical and anesthetic techniques.
Participants will:
- Undergo emergency laparotomy for intestinal obstruction or intestinal perforation.
- Receive either ERAS-based postoperative care or conventional postoperative care.
- Be monitored during their hospital stay for recovery and postoperative complications.
- Be assessed for bowel function recovery, ability to tolerate oral fluids, and length of hospital stay.
- Be followed for 30 days after surgery to determine whether a surgical site infection develops.
The researchers hypothesize that patients managed with the ERAS protocol will have a lower frequency of surgical site infections and improved postoperative recovery compared with those receiving conventional care.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Punjab Province
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Muzaffargarh, Punjab Province, 파키스탄, 34200
- Recep Tayyip Erdogan Hospital Muzaffargarh
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- acute intestinal obstruction or intestinal perforation
- planned for emergency laparotomy
Exclusion Criteria:
- Pregnant women
- Patients on chronic steroids
- Chronic obstructive pulmonary disease
- Malignant ulcers confirmed by histopathological examination
- laparoscopic surgeries
- Acute abdominal trauma
- Patients who require postoperative intensive care unit (ICU) care
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: ERAS Protocol Group
Participants undergoing emergency laparotomy will receive postoperative care according to the Enhanced Recovery After Surgery (ERAS) protocol.
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A standardized multimodal perioperative care pathway applied to patients undergoing emergency laparotomy.
The protocol includes pre-defined components for preoperative optimization, intraoperative management, and postoperative care.
Postoperative elements include early mobilization, early initiation of oral fluids and diet, optimized multimodal analgesia, early removal of tubes/drains when appropriate, and structured fluid management.
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활성 비교기: Conventional Care Group
Participants undergoing emergency laparotomy will receive standard postoperative care as routinely practiced in the surgical unit.
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Standard postoperative management routinely practiced in the surgical unit for patients undergoing emergency laparotomy.
Care includes traditional postoperative monitoring, routine analgesia, delayed initiation of oral intake, standard mobilization practices, and conventional fluid and supportive management.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Surgical Site Infection
기간: From enrollment within 30 days postoperatively
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Frequency of surgical site infection (superficial and deep) occurring within 30 days after emergency laparotomy will be assessed and compared between the Enhanced Recovery After Surgery (ERAS) group and the conventional care group.
Surgical site infection will be defined and classified according to standard surgical infection criteria as specified in the study protocol
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From enrollment within 30 days postoperatively
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hospital Stay
기간: From surgery to discharge within 30 days
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Length of hospital stay will be measured in days from the day of surgery until final disposition (discharge or death).
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From surgery to discharge within 30 days
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Paralytic Ileus
기간: From surgery till hospital stay within 30 days postoperatively
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Incidence of postoperative paralytic ileus defined as presence of abdominal distension with absence of bowel sounds on clinical examination (auscultation for at least one minute).
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From surgery till hospital stay within 30 days postoperatively
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Time to First Stool
기간: From surgery till hospital stay until discharge within 30 days postoperatively
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Time (in days) from surgery to passage of first postoperative stool, indicating return of bowel function.
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From surgery till hospital stay until discharge within 30 days postoperatively
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Time to First Fluid Diet
기간: Postoperatively during hospital stay till discharge within 30 days postoperatively
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Time (in days) from surgery to initiation and tolerance of first oral fluid intake postoperatively.
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Postoperatively during hospital stay till discharge within 30 days postoperatively
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공동 작업자 및 조사자
수사관
- 연구 의자: Muhammad I Seerat, FCPS, Recep Tayyip Erdogan Hospital Muzaffargarh
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- U1111-1342-1146
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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Enhanced Recovery After Surgery에 대한 임상 시험
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