- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Punjab Province
-
Islamabad, Punjab Province, Paquistão, 46000
- Islamabad Medical and Dental College
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
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 |
|
Comparador Ativo: 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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
THE INCIDENCE OF BURST ABDOMEN
Prazo: UPTO 30 DAYS POST SURGERY
|
The number of participants experiencing postoperative disruption of the musculo-fascial layer (complete wound dehiscence) following midline laparotomy.
|
UPTO 30 DAYS POST SURGERY
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of Surgical Site Infection (SSI)
Prazo: UPTO 30DAYS POST SURGERY
|
Occurrence of infection at the surgical site, categorized as superficial, deep, or organ/space infection according to CDC criteria.
|
UPTO 30DAYS POST SURGERY
|
|
Postoperative Seroma and Hematoma Formation
Prazo: Up to 30 days post-surgery.
|
Outcome Measure Description: The occurrence of fluid collection (seroma) or blood collection (hematoma) within the surgical wound.
|
Up to 30 days post-surgery.
|
|
Length of Hospital Stay
Prazo: From date of surgery until date of discharge (approximately 7-14 days).
|
The total number of days the participant remains in the hospital starting from the day of surgery until discharge.
|
From date of surgery until date of discharge (approximately 7-14 days).
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Complicações pós-operatórias
- Processos Patológicos
- Neoplasias por local
- Neoplasias
- Doenças Intestinais
- Neoplasias gastrointestinais
- Neoplasias do Aparelho Digestivo
- Doenças do aparelho digestivo
- Doenças Gastrointestinais
- Neoplasias Intestinais
- Doenças retais
- Doenças do cólon
- Condições Patológicas, Sinais e Sintomas
- Neoplasias Colorretais
- Deiscência da Ferida Cirúrgica
Outros números de identificação do estudo
- CRS-2024-135-8
- 238/IMDC/IREB-2025 (Outro identificador: ISLAMABAD MEDICAL AND DENTAL COLLEGE)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Câncer colorretal
-
Rene MantkeTechnische Universität DresdenRecrutamentoComplicações Pós-Operatórias do Cancro ColorectalAlemanha
-
Chinese PLA General HospitalAinda não está recrutandoTratamento para Cancro Colorectal Avançado | Tratamento para Cancro do Pâncreas Avançado
-
HepaRegeniX GmbHRecrutamentoRessecção Hepática | Metástases Hepáticas de Carcinoma ColorectalEstados Unidos, Israel
-
King's College LondonNational Cancer Institute (NCI); Cancer Research UK; National Cancer Institute... e outros colaboradoresAinda não está recrutandoMecanismos Relacionados com o Microbioma Ligados ao Cancro Colorectal de Início PrecoceReino Unido
-
Daping Hospital and the Research Institute of Surgery...Ainda não está recrutandoLdrt | Metástase Peritoneal de Cancro Gástrico e ColorectalChina
-
Sohag UniversityInscrevendo-se por convite
-
Turku University HospitalLounais-Suomen SyöpäyhdistysAinda não está recrutandoSobrevivente de cancerFinlândia
-
Istanbul Aydın UniversityConcluído
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)RetiradoSobrevivente de cancerEstados Unidos
-
University of Alabama at BirminghamNational Cancer Institute (NCI); Auburn UniversityConcluído