- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07585344
Interrupted 'Figure-of-X' Versus Continuous Suturing Technique for Abdominal Wall Closure in Colorectal Laparotomies (X-CLOSURE)
Interrupted 'Figure-of-X' Versus Continuous Suturing Technique for Abdominal Wall Closure in Colorectal Laparotomies: A Comparative Study on the Incidence of Burst Abdomen
This prospective randomized comparative study aims to evaluate whether interrupted figure-of-X fascial closure reduces the incidence of burst abdomen compared with continuous suturing in patients undergoing open colorectal laparotomy. Burst abdomen is a serious postoperative complication associated with increased morbidity, prolonged hospital stay, and reoperation.
A total of 40 adult patients undergoing elective or emergency colorectal laparotomy will be randomized into two groups: interrupted figure-of-X closure or continuous fascial closure. The primary outcome will be the incidence of burst abdomen within 30 days after surgery. Secondary outcomes will include surgical site infection, seroma, hematoma, and length of hospital stay.
The study is being conducted at the Department of General Surgery, Akbar Niazi Teaching Hospital, Islamabad, Pakistan.
Přehled studie
Postavení
Podmínky
Detailní popis
Burst abdomen, also known as abdominal wound dehiscence, is a major postoperative complication following midline laparotomy. It is associated with increased postoperative morbidity, prolonged hospitalization, need for reoperation, and increased mortality. Although several abdominal wall closure techniques are currently practiced, the optimal method for preventing fascial dehiscence remains controversial.
Continuous mass closure is commonly used because of its technical simplicity and shorter operative time. However, interrupted techniques, including interrupted figure-of-X suturing, may distribute tension more evenly across the wound and potentially reduce the risk of fascial disruption. Previous randomized and observational studies have shown inconsistent results regarding superiority of one closure technique over another, particularly in high-risk abdominal surgeries.
This study aims to compare interrupted figure-of-X closure with continuous fascial closure in patients undergoing colorectal laparotomy. The study will be conducted as a prospective, randomized, single-center comparative trial at Akbar Niazi Teaching Hospital, Islamabad, Pakistan.
After informed consent and eligibility assessment, 40 adult patients undergoing elective or emergency open colorectal laparotomy will be randomized in a 1:1 ratio into two groups:
Group A: Interrupted figure-of-X fascial closure Group B: Continuous fascial closure
Randomization will be performed using computer-generated permuted blocks with allocation concealment through sealed opaque envelopes. Surgeons cannot be blinded because of the nature of the intervention; however, postoperative outcome assessors and data analysts will remain blinded to group allocation.
The abdominal fascia in both groups will be closed using slowly absorbable monofilament sutures according to a standardized operative protocol. Operative variables including suture material, bite spacing, operative duration, contamination level, and postoperative wound complications will be recorded.
The primary outcome will be incidence of burst abdomen within 30 days following surgery. Secondary outcomes will include surgical site infection, seroma formation, hematoma, reoperation, and postoperative length of hospital stay.
The findings of this study may help determine a safer and more effective abdominal wall closure technique in colorectal laparotomy patients and may contribute to improved postoperative surgical outcomes in high-risk populations.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Punjab Province
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Islamabad, Punjab Province, Pákistán, 46000
- Islamabad Medical and Dental College
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Adult patients (aged 18 years and above).
- Patients undergoing open laparotomy for histologically confirmed colorectal cancer.
- Elective surgical procedures.
Exclusion Criteria:
- Patients with a previous midline laparotomy within the last 30 days.
- Patients in whom the abdominal wall is planned to be left open or managed with a temporary closure (open abdomen).
- Patients with known connective tissue disorders (e.g., Ehlers-Danlos syndrome) that might impair wound healing.
- Patients with an expected survival of less than 30 days.
- Emergency laparotomies.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: interrupted figure of X SUTURE
Abdominal wall closure performed using the interrupted 'Figure-of-X' suturing technique.
The fascia is closed with interrupted X-shaped sutures using a slowly absorbable monofilament (PDS) or similar material.
Each suture involves taking 1 cm tissue bites from the fascial edges with approximately 1 cm intervals between each 'X' to ensure secure mass closure.
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For the Figure-of-X: Specify the use of a "slowly absorbable monofilament suture" with "1 cm tissue bites and 1 cm spacing" in an interrupted X-pattern. For the Continuous closure: Specify the use of a "single-layer continuous mass closure" with the same suture material and spacing requirements |
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Aktivní komparátor: CONTINUOUS MASS CLOSURE
: Abdominal wall closure performed using the standard continuous (running) suturing technique.
A single-layer continuous mass closure is executed using a slowly absorbable monofilament suture material.
The technique involves continuous stitching with approximately 1 cm tissue bites and 1 cm intervals between each loop to ensure an even distribution of tension across the midline incision.
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The abdominal fascia is closed using a standard single- layer continuous (running) mass closure technique.
A slowly absorbable monofilament suture is used to provide prolonged tensile strength.
The technique follows a continuous suture line with approximately 1 cm tissue bites from the fascial edges and a 1 cm interval between each loop (travel).
The suture is started at one end of the incision and continued to the other, ensuring even tension throughout the length of the midline laparotomy wound.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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THE INCIDENCE OF BURST ABDOMEN
Časové okno: UPTO 30 DAYS POST SURGERY
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The number of participants experiencing postoperative disruption of the musculo-fascial layer (complete wound dehiscence) following midline laparotomy.
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UPTO 30 DAYS POST SURGERY
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Incidence of Surgical Site Infection (SSI)
Časové okno: UPTO 30DAYS POST SURGERY
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Occurrence of infection at the surgical site, categorized as superficial, deep, or organ/space infection according to CDC criteria.
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UPTO 30DAYS POST SURGERY
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Postoperative Seroma and Hematoma Formation
Časové okno: Up to 30 days post-surgery.
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Outcome Measure Description: The occurrence of fluid collection (seroma) or blood collection (hematoma) within the surgical wound.
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Up to 30 days post-surgery.
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Length of Hospital Stay
Časové okno: From date of surgery until date of discharge (approximately 7-14 days).
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The total number of days the participant remains in the hospital starting from the day of surgery until discharge.
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From date of surgery until date of discharge (approximately 7-14 days).
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Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Pooperační komplikace
- Patologické procesy
- Novotvary podle místa
- Novotvary
- Střevní nemoci
- Gastrointestinální novotvary
- Novotvary trávicího systému
- Nemoci trávicího systému
- Gastrointestinální onemocnění
- Střevní novotvary
- Rektální onemocnění
- Onemocnění tlustého střeva
- Patologické stavy, příznaky a symptomy
- Kolorektální novotvary
- Dehiscence chirurgické rány
Další identifikační čísla studie
- CRS-2024-135-8
- 238/IMDC/IREB-2025 (Jiný identifikátor: ISLAMABAD MEDICAL AND DENTAL COLLEGE)
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