Single Versus Double Stapling and Two Purse-String Techniques in Rectal Cancer Surgery
Single Vs Double Stapling Technique & Intracorporeal Vs Transanal Purse-String in Low Anterior Resection for Rectal Cancer: An Adjusted Comparative RCT Evaluating Anastomotic Leak, Oncological and Patient-Reported Outcomes
This study compares ways of joining the bowel after surgery for rectal cancer. It aims to find out whether using a single-stapling technique leads to fewer bowel leaks than using a double-stapling technique. It also compares two ways of placing the closing stitch used in the single-stapling technique.
The study will include 124 adults having planned surgery to remove rectal cancer while preserving the anus. After removing the affected part of the rectum, the surgeon joins the remaining bowel. A leak can occur if this join does not heal properly.
Participants will be assigned by chance during surgery to one of two techniques:
Double stapling: the surgeon closes the remaining rectum with a straight stapler, then uses a circular stapler to join the bowel.
Single stapling: the surgeon closes the remaining rectum with a drawstring-like stitch, then uses a circular stapler to join the bowel.
Participants assigned to single stapling will have a second assignment by chance. The surgeon will place the closing stitch either from inside the abdomen or through the anus.
The main outcome is a bowel leak that requires treatment within 30 days after surgery. Researchers will also compare other complications, recovery, findings from the removed cancer tissue, and whether the cancer returns locally during the first year.
Participants will be followed for 12 months after surgery. They will complete questionnaires about bowel function, bowel control, and quality of life at 6 and 12 months.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This prospective, single-center randomized controlled trial will be conducted at the Colorectal Unit, Surgery Department, Faculty of Medicine, Alexandria University, Alexandria, Egypt. It will compare single-stapled and double-stapled anastomoses following low anterior resection with total mesorectal excision for rectal adenocarcinoma. Within the single-stapling group, a second randomized comparison will evaluate intracorporeal versus transanal placement of the rectal stump purse-string suture.
The study addresses whether avoiding the intersection between linear and circular staple lines influences anastomotic healing. It will also examine whether the route of purse-string placement affects surgical outcomes, pathological measures of oncological resection, and patient-reported bowel function and quality of life.
Randomization will take place intraoperatively after the surgeon confirms curative resectability and technical feasibility of the allocated approaches. Participants will first be randomized in a 1:1 ratio to single stapling or double stapling. Participants allocated to single stapling will then undergo a second 1:1 randomization to intracorporeal or transanal purse-string placement. The planned allocation is therefore 62 participants to double stapling, 31 to single stapling with an intracorporeal purse-string, and 31 to single stapling with a transanal purse-string.
An independent statistician will prepare the computer-generated randomization sequence. Allocation will be concealed using sequentially numbered, sealed, opaque envelopes until intraoperative randomization. Operating surgeons cannot be blinded. Outcome assessors, including imaging assessors, pathologists, and research staff administering patient-reported outcome questionnaires, will be blinded to allocation. Participants will remain blinded where feasible.
Experienced colorectal surgeons will perform standardized total mesorectal excision. In the double-stapling group, the rectum will be divided and closed with a linear stapler before creation of the anastomosis with a circular stapler. In the single-stapling groups, the rectum will be divided without a linear stapler, and the open rectal stump will be closed with an intracorporeal or transanal purse-string before circular stapling. A defunctioning stoma may be created at the operating surgeon's discretion according to clinical risk factors, and its use will be recorded.
Anastomotic leaks will be defined and graded using the International Study Group of Rectal Cancer classification. The primary comparison will assess clinically significant leaks requiring active treatment without relaparotomy or requiring relaparotomy, corresponding to Grade B or Grade C, within 30 days after surgery. Other postoperative complications will be classified using the Clavien-Dindo system.
Follow-up will assess postoperative recovery, anastomotic complications, pathological resection findings, and local recurrence through one year. Bowel function, fecal continence, and quality of life will be assessed using the Low Anterior Resection Syndrome score, Wexner incontinence score, and European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire at 6 and 12 months after surgery.
The sample size is based on the primary comparison between the combined single-stapling group and the double-stapling group. The primary analysis will follow the intention-to-treat principle, with a supplementary per-protocol analysis. Prespecified adjusted analyses will account for relevant clinical and operative factors. The intracorporeal versus transanal purse-string comparison will be analyzed separately within participants randomized to single stapling.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ahmed Mohi eldein, PhD
- Número de teléfono: +201281362223
- Correo electrónico: Ahmed.eldaoushy@alexmed.edu.eg
Ubicaciones de estudio
-
-
-
Alexandria, Egipto
- Reclutamiento
- Alexandria University
-
Contacto:
- Waleed Elshazly, Prof
- Número de teléfono: +21223493268
- Correo electrónico: wshazly@gmail.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age 18-80 years.
- Histologically confirmed rectal adenocarcinoma, with the tumor located within 16 cm of the anal verge, measured by rigid proctoscopy or magnetic resonance imaging.
- Candidate for elective sphincter-preserving low anterior resection with total mesorectal excision.
- American Society of Anesthesiologists (ASA) physical status classification I-III.
- Ability to provide written informed consent.
Exclusion Criteria:
- Locally advanced disease unsuitable for curative resection or metastatic disease (M1).
- Emergency surgery for obstruction or perforation.
- Previous pelvic radiotherapy for conditions other than the current rectal cancer.
- Planned abdominoperineal resection or Hartmann's procedure.
- Coagulopathy or contraindication to the use of surgical stapling devices.
- Inability to complete follow-up questionnaires.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Double-Stapling Technique (DST)
Participants will undergo low anterior resection with total mesorectal excision, followed by rectal transection and closure using a linear stapler. A transanally introduced circular stapler will then be used to create the colorectal or coloanal anastomosis. Planned enrollment is 62 participants. |
Following low anterior resection with total mesorectal excision, a linear stapler will be used to transect and close the rectal stump. A circular stapler introduced through the anus will then be used to construct the colorectal or coloanal anastomosis.
Otros nombres:
|
|
Experimental: Single-Stapling With Intracorporeal Purse-String (SST-IC)
Participants will undergo low anterior resection with total mesorectal excision. The rectum will be transected without a linear stapler, and a manual purse-string suture will be placed intracorporeally to close the open rectal stump. A transanally introduced circular stapler will then be used to create the colorectal or coloanal anastomosis. Planned enrollment is 31 participants. |
Following low anterior resection with total mesorectal excision, the rectum will be transected using scissors or an energy device without linear stapling. A manual intracorporeal purse-string suture will be placed around the open rectal stump. A circular stapler introduced through the anus will then be used to construct the colorectal or coloanal anastomosis.
Otros nombres:
|
|
Experimental: Single-Stapling With Transanal Purse-String (SST-TA)
Participants will undergo low anterior resection with total mesorectal excision. The rectum will be transected abdominally without a linear stapler, and a purse-string suture will be placed through the anus to close the open rectal stump. A transanally introduced circular stapler will then be used to create the colorectal or coloanal anastomosis. Planned enrollment is 31 participants. |
Following low anterior resection with total mesorectal excision, the rectum will be transected abdominally without linear stapling. A purse-string suture will be placed transanally around the open rectal stump. A circular stapler introduced through the anus will then be used to construct the colorectal or coloanal anastomosis.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Clinically Significant Anastomotic Leak Within 30 Days
Periodo de tiempo: Within 30 days after surgery
|
Percentage of participants with an anastomotic leak classified as Grade B or Grade C according to the International Study Group of Rectal Cancer classification. Grade B requires active treatment without relaparotomy, and Grade C requires relaparotomy. The primary comparison will be between the combined single-stapling group and the double-stapling group. |
Within 30 days after surgery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Postoperative Complications According to the Clavien-Dindo Classification
Periodo de tiempo: Within 30 and 90 days after surgery
|
Percentage of participants experiencing postoperative complications, with severity classified using the Clavien-Dindo system. Complications will be assessed cumulatively at 30 and 90 days after surgery, and the highest complication grade experienced by each participant will be recorded at each assessment. |
Within 30 and 90 days after surgery
|
|
Operative Time
Periodo de tiempo: During the index operation
|
Duration of the surgical procedure, measured in minutes. |
During the index operation
|
|
Estimated Intraoperative Blood Loss
Periodo de tiempo: During the index operation
|
Estimated volume of blood lost during the surgical procedure, measured in milliliters. |
During the index operation
|
|
Conversion From Minimally Invasive to Open Surgery
Periodo de tiempo: During the index operation
|
Percentage of participants whose planned minimally invasive procedure is converted to open surgery. The denominator will include participants in whom a minimally invasive approach was initially attempted. |
During the index operation
|
|
Postoperative Length of Hospital Stay
Periodo de tiempo: From surgery to up to 10 weeks
|
Number of days from the index operation to discharge from the index hospital admission. |
From surgery to up to 10 weeks
|
|
Bowel Function Assessed Using the Low Anterior Resection Syndrome Score
Periodo de tiempo: At 6 and 12 months after surgery
|
Bowel function will be assessed using the five-item Low Anterior Resection Syndrome (LARS) score. Total scores range from 0 to 42, with higher scores indicating worse bowel dysfunction. Scores of 0-20 indicate no LARS, 21-29 indicate minor LARS, and 30-42 indicate major LARS. Scores will be evaluated separately at each assessment. |
At 6 and 12 months after surgery
|
|
Fecal Incontinence Assessed Using the Wexner Incontinence Score
Periodo de tiempo: At 6 and 12 months after surgery
|
Fecal incontinence will be assessed using the Wexner (Cleveland Clinic) Incontinence Score. The five-item score evaluates incontinence to solid stool, liquid stool, and gas, pad use, and lifestyle alteration. Total scores range from 0 to 20, with 0 indicating no incontinence and higher scores indicating more severe incontinence. Scores will be evaluated separately at each assessment. |
At 6 and 12 months after surgery
|
|
Health-Related Quality of Life Assessed Using the EORTC QLQ-C30
Periodo de tiempo: At 6 and 12 months after surgery
|
Health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire. Global health status/quality of life, functional scales, and symptom scales and items will be scored separately according to the scoring manual. Scores range from 0 to 100. Higher global health and functional scores indicate better quality of life or functioning; higher symptom scores indicate worse symptoms. Scores will be evaluated separately at each assessment. |
At 6 and 12 months after surgery
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 0308271
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .