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临床试验/CTRI/2024/09/073802
CTRI/2024/09/073802招募中不适用

Intra-Abdominal Pressure Measurement as Predictor of Postoperative Wound Complications in the Patients Undergoing Emergency Laparotomy: A Prospective Observational Study

All India Institute of Medical Sciences AIIMS1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年9月26日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
Relationship between IAP and postoperative wound healing in patients undergoing emergency laparotomy

研究概览

简要总结

Detailed information regarding the patient’s demographics (age, gender, and body mass index), hemodynamic status at admission, and clinical and biochemical evidence of organ failure will be noted. The operative details (intra-operative findings, type of operative procedure, duration of surgery, drain placement, and skin closure method), postoperative diagnosis, and postoperative wound complications (infection, dehiscence, development of incisional hernia) will be recorded. Measurement of intra-abdominal pressure: Non-invasive measurement of IAP in the form of intra-vesicular pressure will be carried out.

Measurement of intra-abdominal pressure: Non-invasive measurement of IAP in the form of intra-vesicular pressure will be carried out. Each patient was catheterised with a 15 Fr Foley catheter and the bladder will be emptied of urine. Then, 50 ml of saline was instilled into the bladder, and the catheter tubing will be clamped. After one minute, intra-vesicular pressure was measured with a saline manometer at full expiration, with the patient lying in the supine position and relaxed abdominal muscles. Zero reference level will be taken at the mid-axillary line level. A conversion factor of 1.36 was used to convert the measured pressure in centimetres into mm Hg. Intra-abdominal pressure will be measured soon after admission, after completion of the operation, and subsequently at an interval of 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours in the postoperative period. The presence of IAH will be categorized into four grades; Grade 1 (lAP 12 - 15 mm Hg), Grade 2 (lAP 16 - 20 mm Hg), Grade 3 (lAP 21- 25 mm Hg) and Grade 4 (lAP > 25 mm Hg) as per WSACS guideline. The acute physiology and chronic health evaluation (APACHE) ll score will be calculated at the time of admission and 72 hours after laparotomy in all the patients. The abdominal wound complications will be identified according to guidelines recommended by the Centre for Disease Control and Prevention (CDC) for diagnosis of surgical site infections. Wound infection or superficial surgical site infection will be considered when the depth of infection will be confined to the skin, and subcutaneous tissue and wound dehiscence are defined as the separation of the abdominal musculoaponeurotic layers. Complete epithelisation in open wounds and the absence of signs of dehiscence after suture removal in sutured wounds will be considered adequate wound healing. The patients will be discharged when their oral feeding will be considered sufficient to meet daily nutritional requirements, the absence of fever for 48 hours, and a healing abdominal wound can be managed at the residence of the patient. Epithelialization is an essential component of wound healing used as a defining parameter of its success. ln the absence of re-epithelialization, a wound cannot be considered healed.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Patients who underwent emergency laparotomy through a midline incision.

排除标准

  • 1.Patients with a history of prior abdominal surgery 2.Failed attempt at Foley catheterisation at admission 3.Trauma to urinary bladder 4.in whom the abdomen is not closed intentionally for a second look laparotomy.

结局指标

主要结局

Relationship between IAP and postoperative wound healing in patients undergoing emergency laparotomy

时间窗: IAP at admission, after completion of operation, and subsequently at an interval of 6 hours, 12 hours, 24 hours, 48 hours and 72 hours

次要结局

  • 1.Relationship between IAP & different procedures in emergency laparotomies with respect to wound healing(2.Relationship between IAP & different pathologies in emergency laparotomies with respect to wound healing)

研究者

发起方
All India Institute of Medical Sciences AIIMS
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Ashok Kumar Sahoo

All India Institute of Medical Sciences (AIIMS)

研究点 (1)

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