Effect of Retention versus Conventional midline closure in high-risk Laparotomy (RECON Trial): An open label randomized controlled trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Burst abdomen (BA) (evisceration): BA will be defined as defect in midline fascial closure within 30 days of index surgery. BA will be assessed by clinical evaluation or if uncertain on clinical evaluation then radiological imaging i.e ultrasonography will be performed.
研究概览
简要总结
One of the delayed consequences following the laparotomy due to fascial dehiscence are incisional hernias. The occurrence of incisional hernias one-year post-surgery ranges from 9% to 20%, but may exceed 35% to 40 % in patients with risk factors. This signifies a significant health and social issue. An incisional hernia frequently correlates with discomfort and restrictions in occupational activities. Despite the limited consensus among surgeons regarding treatment strategies for incisional hernias, these conditions frequently necessitate surgical intervention, accompanied by associated perioperative risks. An early postoperative fascial dehiscence results in the development of a ruptured abdomen. The research indicates that the reoperation rate for a burst abdomen ranges from 1% to 3%.
The European Hernia Society guidelines advocate for a continuous suture utilizing a slowly absorbable monofilament thread in the ’small bites’ technique (stitch distance from the fascia edge 5–8 mm, inter-stitch distance 5 mm) with a suture-to-wound length ratio of no less than 4:1 for the closure of elective midline laparotomies.
No specific suturing approach can be recommended for the closure of laparotomies in emergency procedures, which carry a heightened risk of wound dehiscence, abdominal rupture, and therefore, incisional hernia, due to insufficient data. The incidence of fascia dehiscence is associated with various risk factors, including hypoalbuminemia, anemia, malnutrition, chronic pulmonary illnesses, and postoperative vomiting and ileus. In such instances, certain studies advocate for the application of supplementary retention sutures to alleviate stress on the fascia suture, hence facilitating improved healing. This approach can diminish the incidence of burst abdomen and hernias, and its application has been proposed as a therapeutic option for addressing fascial dehiscence. However, the European Hernia Society’s guidelines do not endorse the routine application of this fascia closure procedure due to insufficient data. Moreover, these sutures are linked to heightened pain, postoperative discomfort, skin maceration, and wound problems, as they traverse the entire abdominal wall, including the fascia, subcutaneous fat, and skin. This approach has not been widely embraced for routine application. Prophylactic retention sutures may be a viable choice for high-risk patients with several risk factors to prevent fascial dehiscence without significant postoperative sequelae. Nevertheless, projected data are insufficient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who need to undergo a high risk primary midline laparotomy, age 18 years or more who will complete 1 year’s follow-up will be included.
- •Patients included in high risk laparotomy cases will be those who need to undergo an emergency major abdominal operation OR elective major abdominal operation for malignant or inflammatory intra-abdominal diseases OR they had at least one of the following risk factors for postoperative wound failure—coexisting respiratory disease, intraabdominal infection, long-term use of steroids (more than 3 months), obesity, malnutrition, chemotherapy, diabetes, renal insufficiency.
排除标准
- •Pregnant female, patients with serious psychiatric disorder and lack of compliance, poor control of septic source and poor intraperitoneal lavage before closure of abdomen, unable to follow-up 1 year, not giving consent.
- •Patients who undergo re-laparotomy within 30 days of index surgery or died, patients who have had previous abdominal surgery will also be excluded.
结局指标
主要结局
Burst abdomen (BA) (evisceration): BA will be defined as defect in midline fascial closure within 30 days of index surgery. BA will be assessed by clinical evaluation or if uncertain on clinical evaluation then radiological imaging i.e ultrasonography will be performed.
时间窗: Burst abdomen (BA) (evisceration): BA will be defined as defect in midline fascial closure within 30 days of index surgery. BA will be assessed by clinical evaluation or if uncertain on clinical evaluation then radiological imaging i.e ultrasonography will be performed. | Incisional hernia (IH): IH will be assessed in the 1 year of index surgery with clinical examination by an experienced clinician or by imaging with ultrasound/ CT scan by an experienced radiologist. IH will be defined as protrusion of peritoneal sac with content from midline defect.
Incisional hernia (IH): IH will be assessed in the 1 year of index surgery with clinical examination by an experienced clinician or by imaging with ultrasound/ CT scan by an experienced radiologist. IH will be defined as protrusion of peritoneal sac with content from midline defect.
时间窗: Burst abdomen (BA) (evisceration): BA will be defined as defect in midline fascial closure within 30 days of index surgery. BA will be assessed by clinical evaluation or if uncertain on clinical evaluation then radiological imaging i.e ultrasonography will be performed. | Incisional hernia (IH): IH will be assessed in the 1 year of index surgery with clinical examination by an experienced clinician or by imaging with ultrasound/ CT scan by an experienced radiologist. IH will be defined as protrusion of peritoneal sac with content from midline defect.
次要结局
- Surgical site infection will be defined by using CDC guideline within 30 days of index surgery(3 days post-operatively, 1 week, 2 weeks, 3 weeks, 4 weeks)
- Wound complication will be defined by using Southampton Scoring Systems within the 30 days of index surgery.(3 days post-operatively, 1 week, 2 weeks, 3 weeks, 4 weeks)
- Post operative pain will be assessed with VAS (visual analogue scale) on day 1, 3, 7 ,14.(post-operative day 1,3,7 and 14)
- Postoperative complication will be assessed with Clavien Dindo classification(3 days post-operatively, 1 week, 2 weeks, 3 weeks, 4 weeks)
研究者
Dr Ravi Gupta
All India Institute of Medical Sciences Gorakhpur