Preventing Parastomal Hernia Using a Modified Sugarbaker Technique With Composite Mesh During Laparoscopic Abdominoperineal Resection

A Randomized Controlled Trial

Manuel López-Cano, MD; Xavier Serra-Aracil, MD; Laura Mora, MD; José Luis Sánchez-García, MD; Luis Miguel Jiménez-Gómez, MD; Marc Martí, MD; Francesc Vallribera, MD; Domenico Fraccalvieri, MD; Anna Serracant, MD; Esther Kreisler, MD; Sebastiano Biondo, MD; Eloy Espín, MD; Salvador Navarro-Soto, MD; Manuel Armengol-Carrasco, MD

Disclosures

Annals of Surgery. 2016;264(6):923-928. 

In This Article

Methods

Design

A prospective, randomized, parallel-group, and double-blind study was conducted at the Colorectal Surgery Units of 3 tertiary care hospitals in Barcelona, Spain. The objective of the study was to determine whether a mesh was effective in the prevention of a radiologically detected PH when a permanent ostomy is performed through a laparoscopic approach. The study protocol was approved by the Clinical Research and Ethics Committee of the participating centers and all patients gave written informed consent before operation. The study was officially registered under NCT01722565 on clinicaltrials.gov providing additional study information.

Patients

Between January 2012 and January 2014, all consecutive patients scheduled for an elective laparoscopic APR with permanent end sigmoid colostomy to treat cancer of the lower third of the rectum, aged over 18 years, and with a life expectancy of more than 1 year were included in the study, provided that informed consent was obtained. Exclusion criteria were allergy or intolerance to the compounds of the mesh, emergency surgery, nonlaparoscopic approach, prior meshes in the surgical site, life expectancy of less than 1 year, and patient's refusal.

Study Protocol

The control group (without mesh) consisted of patients receiving conventional sigmoid end colostomy. The study group (with mesh) consisted of patients receiving conventional sigmoid end colostomy along with a prosthetic mesh according to the modified Sugarbaker technique.[12] Patients were randomly assigned to one or other group (1 : 1) using a computer-generated list of random numbers generated by an independent statistician. Before operation, randomization was made by a phone call.

Preoperatively, all patients underwent mechanical preparation of the colon and received antibiotic prophylaxis with a single dose of 2 g of amoxicillin-clavulanic acid administered intravenously at induction of anesthesia. The day before surgery, a stomatotherapy nurse marked the ideal site for the colostomy.

The surgical technique was laparoscopic total mesorectal excision as the treatment of patients with very low rectal cancer. Once the resection was completed and the perineal wound was closed, patients randomly assigned to the mesh group had a mesh placed in the intraperitoneal/onlay fashion by a pure laparoscopic approach using a modified Sugarbaker technique. The details of the technique have been previously reported.[12] We used a 15 × 20 cm oval, large-pore lightweight composite mesh (ETHICON PHYSIOMESH Flexible Composite Mesh; ETHICON, Johnson & Johnson Company), composed on a nonabsorbable macroporous polypropylene mesh laminated between 2 polyglecaprone-25 films, with an undyed polydioxanone film that provides the bond between the polyglecaprone-25 film and the polypropylene mesh, and an additional central dyed polydioxanone film marker for orientation purposes. Briefly, the mesh was introduced through the 11 mm trocar and once the mesh was expanded inside the abdominal cavity and maintaining the central marker aligned with the colon, the mesh was fixed to the abdominal wall with a double crown of reabsorbable straps (ETHICON SECURESTRAP; ETHICON, Johnson & Johnson company). Mesh placement time is around 15 minutes.

All patients were operated on by experienced laparoscopic surgeons. The surgical technique was made available to all colorectal surgery units involved in the study. Moreover, homogenization of the procedure among the different centers was made by a demonstration video of the surgical technique carried out by the 2 principal investigators (MLC and XSA) (see video, Supplemental Digital Content 1, http://links.lww.com/SLA/A984, which shows the surgical technique).

The primary variable of the study was the detection of a PH by abdominal computed tomography (CT) at any time over the follow-up period. All patients underwent CT scanning at 12 months after surgery, which is the minimum length of follow-up to assess the development of PH.[14] CT scans were performed in the supine position, with the patient at rest, and with intravenous contrast. Abdominal CT was performed by a radiologist who was blind to the technique used. The presence of PH was assessed according to the classification of Moreno-Matias et al[15] as follows: 0 (normal); I (hernia sac containing stoma loop, Ia: diameter of the hernia sac <5 cm, Ib: diameter of the hernia sac >5 cm); II (sac containing omentum); and III (sac containing a loop other than stoma).

Secondary variables were colostomy- and mesh-related variables. Colostomy-related variables included clinically identified wound dehiscence within 30 days after operation, and prolapse defined as protrusion of the loop or the bowel walls through the stomal opening that may involve the entire wall or only the mucosa. Mesh-related variables included mesh infection defined as a collection in contact with the mesh identified clinically and/or yielding a positive culture within 30 days of operation, and reoperation due to mesh rejection.

Other preoperative and postoperative variables recorded were age, sex, body mass index (BMI), risk factors for PH such as BMI >25 kg/m2, smoking habit, American Society of Anesthesiologists (ASA) physical status classification, diabetes mellitus, history of other hernias, prostatism, and chronic obstructive pulmonary disease (COPD),[16] duration of operation, length of stay, postoperative ileus, type of APR (conventional, intersphincteric), cancer stage (I, II, III, IV), neoadjuvant and adjuvant therapy, distance from the anal verge of the tumors, and infection of the perineal wound. Comorbidity was assessed by the Charlson comorbidity index.[17] The operative mortality was defined as death within 30 days of operation.

Patients were followed at the outpatient clinics of the participating hospitals by staff members who were blinded as to the assignment. Patients were examined at 1 month after surgery (clinical visit and recording of postoperative morbidity data), at 6 months, at 12 months, and every year thereafter. Finalization of the study and reasons for discontinuation were recorded. These included severe adverse event and/or death, insertion of a mesh different from that proposed in the study, protocol violation, and patient's withdrawal of consent to take part in the study. The adherence of surgeons with the protocol was assessed by review of case report forms.

Sample Size and Statistical Analysis

The sample size was calculated with PH as the main variable. According to an expected difference of 40% in the rates of PH between groups (estimated percentage of PH in the control group of 55% and 15% in the mesh group),[15] accepting a beta error of 0.20 and an alpha error of 0.05 in a 2-sided test, 50 patients were required (25 per group). As we assumed a loss to follow-up of 10%, the total sample required for the study was estimated to be 56 patients (28 in each group).

Analysis was performed in the per-protocol data set that included all patients receiving surgery in the control group and in the mesh group who underwent control CT scan 12 months after operation. The description of the variables and the statistical analysis were performed using the Statistical Package for the Social Sciences (SPSS) program (SPSS Inc., Chicago, IL) version 20. Quantitative variables are expressed as mean and standard deviation (SD) when the distribution was considered normal, and otherwise using the median, interquartile interval, and range. Categorical variables are expressed as absolute numbers and percentages. The parametric t test was used for statistical analysis of quantitative variables with independent groups if the conditions for its application were met. For categorical variables, Pearson Chi-square ([chi]2) test was used. The appearance of PH at follow-up identified by CT was analyzed with the Kaplan-Meier estimation method and the log-rank test. The results of the statistical tests are given whenever possible with a confidence interval (CI) of 95%. Statistical significance was set at a P value below 0.05. Also, the benefit of mesh insertion over control was estimated by the number needed to treat (NNT).[18]

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