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临床试验/NCT01907542
NCT01907542Unknown不适用

A Randomized Controlled Trial Comparing Stapled Versus Monocryl Sutured Skin Closure for Elective Open Colectomy.

National University Hospital, Singapore2 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
144
试验地点
2
主要终点
Superficial surgical site infection

研究概览

简要总结

Background Stapled skin closure is frequently performed following open colectomies. However, its pain and cosmetic outcomes have been suboptimal. Monocryl sutured skin closure has been shown to be cosmetically superior and does not require removal of the sutures. But its association with wound infection has been questioned Aims This study aims to compare the outcomes using skin stapler or Monocryl suture in the skin closure following open colectomy. Hypotheses We believe Monocryl suture is associated with reduced pain and better cosmesis. Methodology Inclusion criteria: All patients who underwent elective open colectomy for various etiologies Exclusion criteria: i) Emergency laparotomies ii) Patient who require the creation of a stoma After consenting for the trial, patients will be randomized into either the skin stapler or the Monocryl suture group. Randomization is performed using a computer model. To minimize confounders, the pre-operative preparation and antibiotics regime will be standardized. The closure of the fascia and the skin will also be performed by at least a Registrar. The wounds will then be covered with a thick sterile dressing to blind the patient and the research assistant. The wound will only be reviewed on the POD 3. The patient is scheduled to return on POD 14, POD 30, 3 and 6 months post operatively upon discharge. Some of the variables that will be collected for this study include: 1. Time taken for skin closure 2. Superficial surgical site infection 3. Pain score 4. Cosmesis We aim to enrol 72 participants in each group. Importance/Impact to Medicine This study will validate the role of Monocryl suture as an effective method for skin closure following open colectomy. We believe Monocryl sutured closure can potentially change the practice of surgeons worldwide for the benefits of the patients.

详细描述

Methodology All consecutive patients who are scheduled to undergo elective open laparotomy for colecotomies for cancer/diverticular disease would be invited to participate in the study through written consent. These patients would be randomized into 2 arms, stapler skin closure (n= 72) and continuous absorbable skin closure (n= 72). Patients involved in the study would have their skin closure done by an adequately trained surgeon.

Inclusion criteria

  1. Patients having a preoperative diagnosis requiring abdominal surgery through a single incision, open laparotomy technique, determined preoperatively by the attending surgeon.
  2. Age 21 and above, able to understand the information regarding the study.
  3. Agreeable for randomization and signed consent form.
  4. All elective open colonic resections above the level of the peritoneal reflection.

Exclusion criteria

  1. Patients with known allergy to products.
  2. Pregnant women or breast-feeding mothers.
  3. No signed consent form.
  4. Patients who undergo a Low Anterior Resection or with distal resection margins lower than mid rectum.
  5. Patients who require a stoma to be fashioned.
  6. Patients with previous midline laparotomy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients who underwent elective open colectomy for various etiologies

排除标准

  • Emergency laparotomies
  • Patient who require the creation of a stoma

结局指标

主要结局

Superficial surgical site infection

时间窗: up till 6months post-op

次要结局

  • 1. Time taken for skin closure(up till 6months post-op)
  • 2. Pain score(up till 6months post op)
  • 3. Cosmesis(up till 6months post op)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

E Kesavan

Head of Division, Division of Colorectal Surgery

National University Hospital, Singapore

研究点 (2)

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