Randomized, Controlled, Prospective Trial to Prevent Parastomal Hernia
Randomized, Controlled, Prospective Trial to Prevent Parastomal Hernia
Background: The prevalence of terminal parastomal hernia (PH) after colostomy placement may be as high as 50%. The effect of the PH may range from discomfort to life-threatening complications. Surgical procedures for repairing PH are difficult to perform and present a high-failure rate.
Objective: To reduce the incidence of PH by implanting a lightweight mesh in the sublay position.
Material and Methods: Randomized, controlled, prospective study. Patients were scheduled for permanent end colostomy surgery to treat cancer of the lower third of the rectum, performed by the same colorectal surgery team. An Ultrapro lightweight mesh was inserted in the sublay position in the study group. Using simple randomization, the sample size required was estimated to be 27 per group. Patients were followed-up clinically and radiologically with abdominal computed tomography by an independent clinician and a radiologist who were all blind to the aims of the study, 1 month and every 6 months after surgery.
Results: The groups were homogeneous in terms of their clinical and demographic characteristics. Surgical time and postoperative morbidity were similar in the 2 groups. Mortality was 0. No mesh intolerance was reported. In the clinical follow-up (median: 29 months, range: 13-49), 11/27 (40.7%) hernias were recorded in the control group compared with 4/27 (14.8%) in the study group (P = 0.03). Abdominal computed tomography identified 14/27 (44.4%) hernias in the control group compared with 6/27 (22.2%) in the study group (P = 0.08).
Conclusions: Parastomal placement of a mesh reduces the appearance of PH. The technique is safe, well-tolerated, and does not increase morbidity rates.
A parastomal hernia (PH) is an incisional hernia related to an abdominal wall stoma. A certain degree of PH is considered to be almost inevitable after the formation of the stoma. The opening of the fascia and the pericolostomy tissue can be identified and assessed by digital exploration. Many PH are asymptomatic, but they may create problems ranging from discomfort to life-threatening complications such as perforation, occlusion, or strangulation.
The prevalence of PH ranges widely according to the follow-up time and the type of colostomy. In end colostomy, it varies from 4% to 50% and in loop colostomy between 0% and 30.8%. Most PH develop within the first few years of the creation of the colostomy, but some appear as long as 20 years afterward.
The repair of the PH with a mesh has produced mixed results. The placement of meshes in the intraperitoneal position has achieved low recurrence rates, but serious complications have also been reported, such as the formation of extensive adhesions that may cause intestinal occlusion.
Recent publications have reported that the use of a large-pore lightweight mesh with a low polypropylene content and a high proportion of absorbable material is associated with a low degree of inflammatory reaction. This type of mesh has been used in PH repair, with satisfactory results. The placement of a mesh in the sublay position presents 2 advantages: first, it avoids direct contact between the prosthesis and the intestinal loops, thus avoiding adhesions; second, the intraabdominal pressure keeps the mesh in position and increases its effectiveness.
The high prevalence of PH, and the difficulty of its repair and the low success rates mean that the best solution is to prevent its appearance from the very beginning. The results of Janes et al in a randomized, controlled, prospective study with the insertion of a lightweight mesh at the same time as the colostomy to prevent hernia obtained very positive results. However, as their series of patients was not homogeneous (it included patients receiving urgent and scheduled surgery and presenting different types of pathology), their findings need to be confirmed.
We hypothesized that in a broad sample of homogeneous patients undergoing permanent colostomy the addition of a new large-pore lightweight mesh low in nonabsorbable material in the sublay position would be well tolerated, would reduce the incidence of PH, and would present a minimal rate of complications. The objective was to assess the tolerance of these meshes and to determine the reduction in the incidence of PH after their placement.
Abstract and Introduction
Abstract
Background: The prevalence of terminal parastomal hernia (PH) after colostomy placement may be as high as 50%. The effect of the PH may range from discomfort to life-threatening complications. Surgical procedures for repairing PH are difficult to perform and present a high-failure rate.
Objective: To reduce the incidence of PH by implanting a lightweight mesh in the sublay position.
Material and Methods: Randomized, controlled, prospective study. Patients were scheduled for permanent end colostomy surgery to treat cancer of the lower third of the rectum, performed by the same colorectal surgery team. An Ultrapro lightweight mesh was inserted in the sublay position in the study group. Using simple randomization, the sample size required was estimated to be 27 per group. Patients were followed-up clinically and radiologically with abdominal computed tomography by an independent clinician and a radiologist who were all blind to the aims of the study, 1 month and every 6 months after surgery.
Results: The groups were homogeneous in terms of their clinical and demographic characteristics. Surgical time and postoperative morbidity were similar in the 2 groups. Mortality was 0. No mesh intolerance was reported. In the clinical follow-up (median: 29 months, range: 13-49), 11/27 (40.7%) hernias were recorded in the control group compared with 4/27 (14.8%) in the study group (P = 0.03). Abdominal computed tomography identified 14/27 (44.4%) hernias in the control group compared with 6/27 (22.2%) in the study group (P = 0.08).
Conclusions: Parastomal placement of a mesh reduces the appearance of PH. The technique is safe, well-tolerated, and does not increase morbidity rates.
Introduction
A parastomal hernia (PH) is an incisional hernia related to an abdominal wall stoma. A certain degree of PH is considered to be almost inevitable after the formation of the stoma. The opening of the fascia and the pericolostomy tissue can be identified and assessed by digital exploration. Many PH are asymptomatic, but they may create problems ranging from discomfort to life-threatening complications such as perforation, occlusion, or strangulation.
The prevalence of PH ranges widely according to the follow-up time and the type of colostomy. In end colostomy, it varies from 4% to 50% and in loop colostomy between 0% and 30.8%. Most PH develop within the first few years of the creation of the colostomy, but some appear as long as 20 years afterward.
The repair of the PH with a mesh has produced mixed results. The placement of meshes in the intraperitoneal position has achieved low recurrence rates, but serious complications have also been reported, such as the formation of extensive adhesions that may cause intestinal occlusion.
Recent publications have reported that the use of a large-pore lightweight mesh with a low polypropylene content and a high proportion of absorbable material is associated with a low degree of inflammatory reaction. This type of mesh has been used in PH repair, with satisfactory results. The placement of a mesh in the sublay position presents 2 advantages: first, it avoids direct contact between the prosthesis and the intestinal loops, thus avoiding adhesions; second, the intraabdominal pressure keeps the mesh in position and increases its effectiveness.
The high prevalence of PH, and the difficulty of its repair and the low success rates mean that the best solution is to prevent its appearance from the very beginning. The results of Janes et al in a randomized, controlled, prospective study with the insertion of a lightweight mesh at the same time as the colostomy to prevent hernia obtained very positive results. However, as their series of patients was not homogeneous (it included patients receiving urgent and scheduled surgery and presenting different types of pathology), their findings need to be confirmed.
We hypothesized that in a broad sample of homogeneous patients undergoing permanent colostomy the addition of a new large-pore lightweight mesh low in nonabsorbable material in the sublay position would be well tolerated, would reduce the incidence of PH, and would present a minimal rate of complications. The objective was to assess the tolerance of these meshes and to determine the reduction in the incidence of PH after their placement.