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Interrupted 'Figure-of-X' Versus Continuous Suturing Technique for Abdominal Wall Closure in Colorectal Laparotomies (X-CLOSURE)

21 de maio de 2026 atualizado por: Islamabad Medical and Dental College

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

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

Intervencional

Inscrição (Real)

40

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Punjab Province
      • Islamabad, Punjab Province, Paquistão, 46000
        • Islamabad Medical and Dental College

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

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

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

7 de novembro de 2025

Conclusão Primária (Real)

5 de abril de 2026

Conclusão do estudo (Real)

15 de maio de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

7 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de maio de 2026

Primeira postagem (Real)

13 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

26 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

To protect participant privacy and maintain the confidentiality of sensitive medical information related to colorectal cancer treatment, individual participant data (IPD) will not be made available for public sharing. Data collected for this study will be used strictly for the purposes outlined in the study protocol and will only be accessible to the research team and institutional oversight committees. Aggregate results and study outcomes will be shared through peer-reviewed publications and conference presentations.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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 .

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