Surgeon Perception of Gastric Decompression at Time of Gynecologic Laparoscopy, a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Adequate gastric decompression
研究概览
简要总结
The goal of this clinical trial is to test whether it is necessary to decompress the stomach during gynecologic laparoscopy.
The main questions it aims to answer are:
- Is there appropriate visualization during surgery without stomach decompression?
- Can the surgeon tell the stomach is decompressed?
- Is the stomach at risk for injury during surgery?
- How is the patient's postoperative experience affected?
Participants will undergo their planned surgery as usual and will be asked to complete log about their recovery for the first week after surgery.
Researchers will compare patients who have their stomach decompressed during surgery to those who do not undergo stomach decompression to see if it is necessary.
详细描述
Enhanced Recovery After Surgery (ERAS) pathways are a framework for management before, during, and after surgery that has demonstrated several benefits from a cost, complication, and satisfaction standpoint. In the field of gynecologic surgery, the American College of Obstetricians and Gynecologists (ACOG) recommends utilization of these pathways with particular emphasis on the importance of implementation of multiple components together. A literature review of 47 ERAS programs specific to obstetrics and gynecology (requiring at least four individual components of ERAS for inclusion) overall supported its use, however, recommended randomized control trials to evaluate each component of the pathway.
One component of the ERAS pathway includes gastric decompression in the perioperative setting. In 1999, before the advent of ERAS, an anesthesiologist recommended routine use of intraoperative gastric decompression to reduce risk of gastric perforation, citing laparoscopic general surgery anesthesia recommendations from 1993. The general surgery paper highlights the possibility for unintentional gastric distention with mask ventilation prior to anesthesia induction with associated increased risk of trocar injury, however, does not discuss incidence or rates of this phenomena. There is discussion of an association with increased intraabdominal pressure and regurgitation of gastric contents, however, nasogastric decompression is not addressed within this context.
Indications for nasogastric tube use in general include treatment of ileus, administration of medications, enteral nutrition, and stomach lavage. Currently available anesthesia recommendations include routine use of gastric tubes during induction with general endotracheal anesthesia. Importantly, it is noted that gastric drainage or suction does not remove particulate matter or guarantee full emptying. In fact, one study looking at use of nasogastric intubation after induction of anesthesia found that patients who underwent nasogastric intubation had significant gastroesophageal reflux disease in the perioperative period and a reduced ability to clear refluxed acid from the distal esophagus. Several other studies examining the routine placement of a nasogastric tube following abdominal surgery also found that patients who underwent gastric decompression had higher rates of fever, pneumonia, and other pulmonary complications. In these studies, those with a nasogastric tube had lower rates of emesis, but increased patient discomfort, no significant difference in the rates of nausea, and longer time to return of bowel function. One comparative study from the general surgery literature evaluating nasogastric decompression during open abdominal surgeries included a subgroup without placement at all in the perioperative period. This subgroup demonstrated significantly less events of atelectasis, fever, and patient discomfort. Furthermore, the routine use of gastric decompression is not benign, and some evidence suggests the benefits of routinely avoiding nasogastric intubations outweigh the risks.
Data has shown that early post-operative nasogastric tube discontinuation (including prior to transfer to post-anesthesia care) is associated with faster return to bowel function and decreased rates of postoperative ileus, as well as decreased hospital stay and rates of pulmonary complications. While it is commonplace for recommended ERAS diet status leading up to and after surgery in most institutions, (i.e., elimination of mechanical bowel prep, removal of nasogastric decompression prior to extubation), there is no clinical evidence available to date on utilization of intraoperative gastric decompression specifically for gynecologic laparoscopic cases.
Additionally, nasogastric or orogastric tubes may contribute to high costs of the operating room. On average, a nasogastric tube costs on average 4 dollars and seventy-five cents (based on cost for pack of 10) at this institution according to 2023 supply invoices. In 2022, a call to action in the Journal of Minimally Invasive Gynecologic Surgery urged gynecologic surgeons to consider their role in safe and green practices in the operating room. Evaluating use of routine gastric decompression at time of gynecologic surgery is an opportunity to decrease potential costs and environmental impact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
盲法说明
- Patient will masked to group assignment and will be under anesthesia during intervention.
- Surgeon will be masked to group assignment. Placement of the nasogastric or orogastric tube will occur while the surgeon is scrubbing and out of the room. There will be a drape over the face until the surgical drapes are covering the patient to maintain surgeon blinding. Removal of tube will take place prior to undraping the patient to maintain blinding.
- All documents noted group assignment will be in an opaque envelope.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Undergoing gynecologic laparoscopy for the following indications: hysterectomy, adnexal surgery, benign and malignant tumors or disease, diagnostic purposes, lysis of adhesions, and pelvic pain.
- •Surgery being performed by gynecologic surgeon with or without minimally invasive gynecologist certification, gynecologic oncologists, urogynecologists, and reproductive endocrinologists.
排除标准
- •Entry sites other than umbilical
- •Planned or high suspicion for bowel surgery
- •Anticipated surgical time >4 hours
- •Known diagnosis of gastric reflux disease or peptic ulcer disease
- •Prior history of gastric or esophageal surgery excluding endoscopy
- •Day of surgery emesis events
- •Difficult intubation determined by anesthesia
- •Intrauterine pregnancy
- •Chronic lung disease
- •Individuals with smoking history.
- •Individuals who do not speak English due to limitations in ability to reliably obtain informed consent in their primary language.
结局指标
主要结局
Adequate gastric decompression
时间窗: At time of surgery
The primary endpoint is the percentage of cases rated as adequate decompression by the surgeon.
Gastric injury
时间窗: Up to six weeks post-operatively
The primary safety endpoint is the estimated negligible rate of gastric injury.
次要结局
- Entry proximity(At time of surgery)
- Post-operative experience questionnaire(First 7 days after surgery)
- Presence of gastric decompression tube(At time of surgery)
- Gastric injury risk assessment(At time of surgery)
- Degree of stomach decompression(At time of surgery)
- Post-operative complications(Up to six weeks post-operatively)
研究者
Magdy Milad, MD
Chief of Minimally Invasive Gynecologic Surgery
Northwestern University
