Wound complications, increased hospital stays and post-operative morbidity are all common following abdominal surgery. Abdominal closure complications are strongly associated with the closure technique and material used. The traditional closure technique used by surgeons is placing the wide and large stitches. A randomized controlled trial done in Sweden described a new closure technique in surgeries by placing the stitches closer to each other by using narrow. The results showed lower incidence of wound infections, hernias, and wound rupture. However, the study provides low quality evidence on the benefits of this new technique since it has numerous limitations like lack of standardization of suture size, lack of proper randomization, and heterogeneity in patient eligibility which will increase result bias. There is still a need for quality evidence on the effectiveness of this new closing technique procedure at decreasing wound complications after the operation.
In this trial the investigators will compare two techniques in the closure of abdominal wounds in patients undergoing abdominal surgery. The first technique will be the traditional closure technique currently used in abdominal surgery. The second technique will be using the new closure technique. The closure of abdominal wounds with small and close sutures using the new technique is expected to lower the incidence of hernia and wound complications as well as improve the quality of life of the patient. Potential candidates for the study are those who will be undergoing elective midline laparotomy at AUBMC. The patients and assessor of outcomes will be blinded and patients will be randomized to receive either the traditional or new closure operation technique. There are no anticipated risks for those participating in the study. All data and information collected will be kept confidential.
Hypothesis:
Closure of abdominal fascia in elective midline laparotomy incisions with small and close sutures compared to closure with conventional wide and distant sutures results in lower rates of wound rupture, incisional hernia, and wound infection, and improved quality of life.
Significance:
The results of this study will allow surgeons to assess the role of a new abdominal closure technique in decreasing short and long term postoperative complications, for a commonly performed procedure. This trial will generate evidence-based conclusions.
Age 18 years or older
Signed Informed Consent
Undergoing an elective laparotomy through a midline incision
Undergoing a midline laparoscopic procedure (midline laparoscopic extraction site)
Emergency surgery
Laparotomy through an incision other than midline
Previous midline laparotomy
Presence of incisional or ventral hernia at time of laparotomy
Parallel
New closure technique
Procedure/SurgeryIn the intervention arm, an average of two sutures will be placed at each cm length of the wound, thus the number of sutures placed should be equal to at least double the length of the wound in cm.The aim is to have a ratio of 4:1 between the overall lengths of the suture to the length of the wound being closed
Incisional hernia
We will define incisional hernia according to the European Society of Hernia: "any abdominal wall gap with or without bulge in the area of a postoperative scar perceptible or palpable by clinical examination or imaging". (7) Using both clinical exam and imaging if performed, these hernias will be described according to their location along the midline, size of the defect using vertical and transverse measurements, and reducibility of any protruding viscera upon lying down or following gentle pressure by the examining hand. Also, we will collect information whether the hernia is causing any pain, discomfort, decrease in mobility, or any incidence of incarceration where the hernia contents protrude and does not reduce to the abdomen upon gentle pressure.
Fascial dehiscence or evisceration
Fascial dehiscence is defined as gapping of the fascia by at last 1 cm with loosening of the surgical sutures. This presents initially with increased serous fluid drainage from the wound. This may be self-limited or progress to a wider gap with herniation of the abdominal viscera, usually the small bowel or the greater omentum, through the defect. The excessive fluid drainage results in opening of the superficial skin incision in some patients and this necessitates emergency surgery for repeat closure of the abdominal wall.
Intervention rate for wound complications
Intervention includes incision and drainage for a wound infection, evacuation of a hematoma, aspiration of a seroma, or reoperation for a wound dehiscence.
Wound seroma
Wound seroma defined as collection of serous fluid in the subcutaneous space, detected either clinically or by ultra-sound examination. o Wound seroma is an established risk factor for wound infection and further resultant morbidities
Wound infection
Wound infection will be defined according to the Centers of Disease Control CDC criteria for Surgical Site Infection SSI. Wound infection is a well known cause of fascia dehiscence. In addition, fascia closure technique resulting in fascia ischemia will result in deep surgical site infection, which in turn can lead to fascia dehiscence. The Sweden group believe that the wide fascia bite result in higher risk of fascia ischemia and thus delayed fascia healing or higher risk of deep wound (fascia) infection and higher risk of fascia gapping.
Intensity of Pain
Pain will be measured using "0-10 Numeric Pain Rating Scale" on post-operative day (POD) 1, POD 7, and on discharge (if the patient stays less than 7 days). The scale ranges from 0-10, 0 being the minimum score for pain intensity and 10 the maximum score for pain intensity. The values in the pain scale represent the pain level as follows: Zero means no pain at all, 1-3 means mild pain, 4-6 means moderate pain and 7-10 means severe pain.The research assistant will collect information on pain killers given to the patients post-operative. There are no sub scales in this measurement. This information will be taken into consideration when assessing pain intensity.
Quality of Life (QOL)
Quality of life will be measured using the "Short Form (SF-36) Health Survey Questionnaire", which has been validated in the Arabic language. The survey will assess the health related quality of life of the participants. The survey includes eight sections: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Aggregate scores are compiled as a percentage of the total points possible, using the Research ANd Development (RAND) scoring table. The scores from those questions that address each specific area of the functional health status are then averaged together, for a final score within each of the 8 sections measured. All 8 sections are scored in the same way.
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