Nasogastric Tube After Laparoscopic Heller-Dor Myotomy
Nasogastric Tube After Laparoscopic Heller-Dor Myotomy: do You Really Need it?
The goal of this prospective observational study is to evaluate the role of nasogastric tube (NGT) in patients with achalasia underwent to Heller-Dor laparoscopic. The main question it aims to answer are:
• If it is possible to remove NGT at the end of surgery. Participants will be dived in two groups: the first one with NGT after surgery and second one without NGT (noNGT).
If there is a comparison group: Researchers will compare group NGT and group noNGT to see if routine placement of NGT is useless.
연구 개요
상세 설명
Achalasia is a rare disease characterized by dysfunction of low oesophageal sphincter. This disease is divided according to Chicago classification into three subtypes.
Laparoscopic Heller - Dor is a important treatment of types I and II Achalasia. There are several studies evaluating the NGT in colorectal, hepatic, urologic, thoracic, otorhinolaryngology, gastric and esophageal surgery. Its use in postoperative period in achalasic patients is not yet clear.
Historically, NGT has been used to reduce gastric distention, nausea, vomiting and chest pain.
The aim of our study is to value the role of NGT for this surgery. We prospectively enrolled achalasic patients undergoing laparoscopic Heller -Dor .
The NGT group and noNGT were compared in terms of perioperative outcomes.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Napoli, 이탈리아, 800131
- AOU. policlinico, Federico II
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- patients with achalasia of type I and II
- patients undergoing laparoscopic Heller-Dor
- patients older than 18 years
- both sexes
Exclusion Criteria:
- pregnant patients;
- patients a history of abdominal surgery;
- body mass index (BMI) >40;
- American Society of Anesthesiology (ASA) score >4;
- megaesophagus;
- III type Achalasia;
- previously treated for this disease.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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with NGT
In these patients, the nasogastric tube remains after surgery.
It was removed after x-ray test.
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The intervention consists in removing or not the nasogastric tube at the end of the surgery.
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noNGT
In these patients, NGT was removed at the end of surgery.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Nausea
기간: in the first postoperative day
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clinically evaluating the presence or absence
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in the first postoperative day
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vomiting
기간: in the first postoperative day
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clinically evaluating the presence or absence
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in the first postoperative day
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chest pain
기간: in the first postoperative day
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clinically evaluating the presence or absence
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in the first postoperative day
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Length of stay
기간: from the first postoperative day to the third postoperative day
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days of hospitalization from first postoperative day
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from the first postoperative day to the third postoperative day
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First flatus
기간: from the first postoperative day to the third postoperative day
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on which postoperative day the patient had the first flatus.
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from the first postoperative day to the third postoperative day
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Intake liquid diet
기간: from the first postoperative day to the third postoperative day
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when the patient starts drinking
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from the first postoperative day to the third postoperative day
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반고형식 섭취(일)
기간: from the first postoperative day to the third postoperative day
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환자가 식사를 시작하면
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from the first postoperative day to the third postoperative day
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postoperative complications
기간: from the first postoperative day to the third postoperative day
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Based on Clavien-Dindo classification
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from the first postoperative day to the third postoperative day
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Hoshino M, Omura N, Yano F, Tsuboi K, Kashiwagi H, Yanaga K. Immunohistochemical study of the muscularis externa of the esophagus in achalasia patients. Dis Esophagus. 2013 Jan;26(1):14-21. doi: 10.1111/j.1442-2050.2011.01318.x. Epub 2012 Feb 6.
- Andolfi C, Fisichella PM. Meta-analysis of clinical outcome after treatment for achalasia based on manometric subtypes. Br J Surg. 2019 Mar;106(4):332-341. doi: 10.1002/bjs.11049. Epub 2019 Jan 28.
- Arcerito M, Jamal MM, Perez MG, Kaur H, Sundahl A, Moon JT. Esophageal Achalasia: From Laparoscopic to Robotic Heller Myotomy and Dor Fundoplication. JSLS. 2022 Jul-Sep;26(3):e2022.00027. doi: 10.4293/JSLS.2022.00027.
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
기타 연구 ID 번호
- 292/190
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Patients Number Length of stay (day) First flatus (day) Intake liquid diet (day) Intake semi-solid diet (day) Intraoperative complications
Postoperative complications:
- Grade I
- Grade II
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비위관에 대한 임상 시험
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