Effect of Oral Laxative Use Before Colorectal Surgery on Intraoperative Surgical Difficulty (OLAX-CRC)
10 de septiembre de 2026 actualizado por: IBRAHIM DOGAN, Van Training and Research Hospital
This prospective randomized pilot study will evaluate whether the use of an oral laxative before elective laparoscopic colorectal surgery affects small-bowel diameter and intraoperative surgical difficulty.
Adult patients scheduled for elective laparoscopic colorectal resection will be randomly assigned to receive either oral laxative plus rectal enema preparation or rectal enema preparation alone.
During surgery, the diameters of the jejunum and ileum will be measured using a standardized method.
The study will also compare operative difficulty, bowel manipulation time, operation duration, need for additional ports, conversion to open surgery, intraoperative complications, blood loss, and early postoperative outcomes between the two groups.
The findings may help clarify whether oral laxative use influences intraoperative conditions during laparoscopic colorectal surgery.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
Mechanical bowel preparation is commonly used before elective colorectal surgery. Although its effects on postoperative outcomes have been widely investigated, limited evidence is available regarding the effect of oral laxatives on intraoperative small-bowel distension and technical difficulty during laparoscopic colorectal surgery. Increased intraluminal fluid following oral laxative administration may lead to small-bowel distension, potentially impairing surgical exposure and increasing the need for bowel manipulation.
In this study, small-bowel diameter will be assessed intraoperatively using a standardized measurement method after laparoscopic access and establishment of pneumoperitoneum. Jejunal diameter will be measured approximately 50 cm distal to the ligament of Treitz, and ileal diameter approximately 20 cm proximal to the ileocecal valve. Measurements will be performed in the transverse plane without applying mesenteric tension and, when feasible, the mean of two measurements will be recorded. At the end of the operation, the operating surgeon will assess overall operative difficulty using a Likert-type scale ranging from very easy to very difficult. This pilot study is intended to provide preliminary evidence for the design of future adequately powered studies and to support the evaluation of current bowel-preparation practices.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: İbrahim Doğan
- Número de teléfono: +905313884966
- Correo electrónico: dogan_203@hotmail.com
Ubicaciones de estudio
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Van
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Van, Van, Turquía (Türkiye), 65300
- Reclutamiento
- University of Health Sciences Türkiye, Van Training and Research Hospital
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Contacto:
- İbrahim Doğan
- Número de teléfono: +905313884966
- Correo electrónico: dogan_203@hotmail.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age 18 years or older
- Scheduled for elective laparoscopic colorectal resection
- American Society of Anesthesiologists (ASA) physical status I-III
- Able and willing to provide written informed consent
Exclusion Criteria:
- Requirement for emergency surgery
- Mechanical intestinal obstruction, gastrointestinal perforation, or generalized peritonitis
- Anticipated extensive intra-abdominal adhesions
- Active inflammatory bowel disease
- Pregnancy
- Serious systemic disease constituting a contraindication to oral laxative use
- Inability to perform standardized intraoperative small-bowel diameter measurements
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Oral Laxative Plus Rectal Enema
Participants assigned to this arm will receive preoperative bowel preparation consisting of an oral laxative combined with a rectal enema before elective laparoscopic colorectal surgery.
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Participants assigned to the experimental arm will receive an oral laxative as part of preoperative mechanical bowel preparation, in addition to a rectal enema, before elective laparoscopic colorectal surgery.
The oral laxative will be administered according to the institution's standard preoperative bowel preparation protocol.
Participants in both study arms will receive a rectal enema as part of preoperative bowel preparation before elective laparoscopic colorectal surgery.
Participants in the comparator arm will receive the rectal enema without an oral laxative.
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Comparador activo: Rectal Enema Alone
Participants assigned to this arm will receive preoperative bowel preparation consisting of a rectal enema alone, without an oral laxative, before elective laparoscopic colorectal surgery.
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Participants in both study arms will receive a rectal enema as part of preoperative bowel preparation before elective laparoscopic colorectal surgery.
Participants in the comparator arm will receive the rectal enema without an oral laxative.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Intraoperative Jejunal Diameter
Periodo de tiempo: Intraoperatively, after laparoscopic access and establishment of pneumoperitoneum
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Jejunal diameter will be measured in centimeters approximately 50 cm distal to the ligament of Treitz, in the transverse plane, under standard pneumoperitoneum pressure and without applying mesenteric tension.
When feasible, two measurements will be obtained and their mean will be recorded.
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Intraoperatively, after laparoscopic access and establishment of pneumoperitoneum
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Intraoperative Ileal Diameter
Periodo de tiempo: Intraoperatively, after laparoscopic access and establishment of pneumoperitoneum
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Ileal diameter will be measured in centimeters approximately 20 cm proximal to the ileocecal valve, in the transverse plane, under standard pneumoperitoneum pressure and without applying mesenteric tension.
When feasible, two measurements will be obtained and their mean will be recorded.
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Intraoperatively, after laparoscopic access and establishment of pneumoperitoneum
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Operative Difficulty Score
Periodo de tiempo: At the end of surgery, on the day of the procedure
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Overall operative difficulty will be assessed by the operating surgeon at the end of the procedure using a 5-point Likert scale: 1 = very easy, 2 = easy, 3 = moderate, 4 = difficult, and 5 = very difficult.
Higher scores indicate greater operative difficulty.
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At the end of surgery, on the day of the procedure
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Estimated Intraoperative Blood Loss
Periodo de tiempo: Intraoperatively, on the day of surgery
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The estimated volume of blood lost during surgery, as recorded in the operative and anesthesia records.
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Intraoperatively, on the day of surgery
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Incidence of Intraoperative Serosal Injury
Periodo de tiempo: Intraoperatively, on the day of surgery
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The number of participants who experience an unintended serosal injury during surgery, as documented in the operative record.
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Intraoperatively, on the day of surgery
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Incidence of Intraoperative Organ Injury
Periodo de tiempo: Intraoperatively, on the day of surgery
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The number of participants who experience an unintended injury to an intra-abdominal organ during surgery, as documented in the operative record.
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Intraoperatively, on the day of surgery
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Incidence of Intraoperative Bleeding Requiring Intervention
Periodo de tiempo: Intraoperatively, on the day of surgery
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The number of participants who experience intraoperative bleeding requiring an additional hemostatic intervention beyond routine surgical hemostasis.
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Intraoperatively, on the day of surgery
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Requirement for an Additional Laparoscopic Port
Periodo de tiempo: Intraoperatively, on the day of surgery
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The number of participants in whom placement of at least one additional laparoscopic port beyond the planned port configuration is required to complete the procedure.
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Intraoperatively, on the day of surgery
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Conversion From Laparoscopic to Open Surgery
Periodo de tiempo: Intraoperatively, on the day of surgery
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The number of participants whose planned laparoscopic procedure is converted to an open surgical approach.
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Intraoperatively, on the day of surgery
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Incidence of Any Postoperative Complication Within 30 Days
Periodo de tiempo: From the day of surgery through postoperative day 30
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The number of participants who experience at least one surgery-related postoperative complication within 30 days after surgery.
Each participant will be counted once, regardless of the number of complications experienced.
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From the day of surgery through postoperative day 30
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Incidence of Anastomotic Leakage Within 30 Days
Periodo de tiempo: From the day of surgery through postoperative day 30
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The number of participants who develop an anastomotic leak within 30 days after surgery, as documented by clinical, radiological, endoscopic, operative, or drainage findings.
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From the day of surgery through postoperative day 30
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Incidence of Surgical Site Infection Within 30 Days
Periodo de tiempo: From the day of surgery through postoperative day 30
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The number of participants who develop a surgical site infection within 30 days after surgery, including superficial incisional, deep incisional, or organ/space infection.
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From the day of surgery through postoperative day 30
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Incidence of Postoperative Ileus Within 30 Days
Periodo de tiempo: From the day of surgery through postoperative day 30
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The number of participants who develop postoperative ileus within 30 days after surgery, as documented in the medical record based on delayed recovery or interruption of gastrointestinal function.
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From the day of surgery through postoperative day 30
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Time Required for Bowel Manipulation and Displacement
Periodo de tiempo: Intraoperatively, on the day of surgery
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The time required to manipulate the bowel and displace it from the operative field during surgery.
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Intraoperatively, on the day of surgery
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Time Required for Intraoperative Bowel Diameter Measurements
Periodo de tiempo: Intraoperatively, on the day of surgery
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The time required to perform intraoperative measurements of the jejunal and ileal diameters.
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Intraoperatively, on the day of surgery
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Time Required to Complete the Anastomosis
Periodo de tiempo: Intraoperatively, on the day of surgery
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The time from initiation of anastomosis construction to completion of the anastomosis during surgery.
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Intraoperatively, on the day of surgery
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Total Operation Time
Periodo de tiempo: Intraoperatively, on the day of surgery
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The total duration of the surgical procedure, defined as the time from skin incision to completion of skin closure.
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Intraoperatively, on the day of surgery
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
22 de mayo de 2026
Finalización primaria (Estimado)
22 de mayo de 2027
Finalización del estudio (Estimado)
22 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
5 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de septiembre de 2026
Publicado por primera vez (Actual)
15 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026/05-02
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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