Department of Medical-Surgical Sciences and Translational Medicine, St. Andrea Hospital, School of Medicine and Psychology, University Sapienza of Rome, Rome, Italy
BACKGROUND: Obstructed defecation syndrome is a widespread and disabling disease.
OBJECTIVE: We aim to evaluate the safety and efficacy of stapled transanal rectal resection performed with a new dedicated curved device in the treatment of obstructed defecation syndrome.
DESIGN: A retrospective review of 187 stapled transanal rectal resections performed from June 2007 to February 2011 was conducted.
SETTINGS: The entire study was conducted at a university hospital.
PATIENTS: All the patients with symptomatic obstructed defecation syndrome and the presence of a rectocele and/or a rectorectal or rectoanal intussusception, in the absence of sphincter contractile deficiency, were included in the treatment protocol.
INTERVENTIONS: All procedures were performed with the use of the Contour Transtar device. We analyzed the functional results of this technique, the incidence and features of the surgical and functional complications, and ways to prevent or treat them.
MAIN OUTCOME MEASURES: Constipation was graded by using the Agachan-Wexner constipation score; use of aids to defecate and patient satisfaction were assessed preoperatively and 6 months after surgery. Intraoperative and postoperative complications were also investigated.
RESULTS: The constipation intensity was statistically reduced from the preoperative mean value of 15.8 (± 4.9) to 5.2 (± 3.9) at 6 months after surgery (p < 0.0001). Of the 151 (80.3%) patients who took laxatives and the 49 (26.2%) who used enemas before treatment, only 25 (13.2%; p < 0.0001) and 7 (3.7%; p < 0.0001) continued to do so after surgery. None of the 17 (9.1%) patients who had previously helped themselves with digitations needed to continue this practice. Almost all patients showed a good satisfaction rate (3.87/5) after the procedure.
LIMITATIONS: Limitations are the short follow-up of 1 year and the design of the study that may introduce potential selection bias.
CONCLUSIONS: The results of this study show that stapled transanal rectal resection performed with the use of the Contour Transtar is a safe and effective procedure to treat obstructed defecation syndrome.
Obstructed defecation syndrome afflicts more than 12.3% of women between 40 and 69 years of age.1 Obstructed defecation syndrome (ODS) is a multifactorial disease related to the association of functional and anatomical disorders.2–4 Surgical treatment of this syndrome is directed to resolution of the obstruction (rectorectal or rectal-anal intussusception, external rectal prolapse, anterior rectocele, enterocele, and/or sigmoidocele) and to improve mechanical expulsive forces.
In recent years, various types of surgical procedures have been proposed to treat ODS, but no one has found unanimous consensus, not even with using the stapled transanal rectal resection (STARR). This technique involves resection of the mucosa, submucosa, and rectal muscle wall by using 2 applications of a circular stapler designed for the procedure for prolapsed hemorrhoids (Ethicon Endo-Surgery, Cincinnati, OH).
The results of STARR with a double procedure for prolapsed hemorrhoids are good, but the technique has been criticized owing to certain limitations, such as incomplete visualization of the operative field related to the use of a nondedicated instrument.5–10
The introduction of a stapler with a curved profile (CCS-30 Contour Transtar, Ethicon Endo-Surgery, Cincinnati, OH) offered an alternative approach to perform transanal full-thickness rectal resection, with the potential advantage of better visualization during the procedure.11
In 2007, we started to perform STARR with CCS-30 with good results. In this article, we present a summary of our 3-year experience with this procedure.
From June 2007 to February 2011, in our department of surgery, all patients who visited the clinic because of the presence of ODS after failure of medical and dietary therapy were evaluated as candidates to undergo a STARR with CCS-30.
All patients were preoperatively studied with the Agachan-Wexner Constipation Scoring System (CSS) test,12 magnetic resonance or traditional cinedefecography, and anorectal manometry to assess the presence of ODS and evaluate the kinetics and function of the pelvic floor muscles.13–17 All the patients with symptomatic ODS (CSS score greater than 10) and the presence (determined through cinedefecography) of a rectocele that did not empty and/or a rectorectal or rectoanal intussusception, in the absence of anal sphincter contractile deficiency (such as hypotonia, anismus, and abdominopelvic dyssynergia), were included in the treatment protocol. Patients with sphincter contractile deficiency were treated with pelvic floor rehabilitation and then reevaluated to be subjected to surgery.18,19
According to our proctological protocol, all patients who were over 40 years of age were preoperatively subjected to colonoscopy. The patients were followed with office visits at 7 and14 days and 1, 3, 6, 9, and 12 months after surgery.
The efficacy of the intervention was assessed by a senior surgeon or resident preoperatively and at office visit 6 months after the intervention according to the following: the degree of constipation as determined by the CSS test; the use of laxatives, enemas, or digitations; and the degree of patient satisfaction, as identified on a scale of 1 to 5. To better assess how the improvement induced by STARR was perceived, we analyzed the satisfaction score also in a subgroup of patients who have, already for many years, life conditioned by the need to evacuate.
We chose patients who had had ODS for more than 10 years (the midpoint of the constipation duration in year section of CSS), because we believe that 10 years represents an appropriate parameter to obtain a group of subjects with the quality of life and especially their daily activity that were conditioned by the need to obtain a satisfactory evacuation.
Patients’ biographical and surgical data, such as age, sex, BMI, ASA score, operative time, and postoperative complications, were prospectively recorded in a computerized database.
All the patients signed a consent form approved by our institute ethics committee before the operation.
All patients are prepared with a mechanical bowel preparation of 2 L of polyethylene glycol solution on the day before the procedure and with an enema 2 to 3 hours before the intervention. Antibiotic prophylaxis is always administered with 500 mg of metronidazole and 400 mg of ciprofloxacin or 500 mg of metronidazole and 1 g of cefotaxime.
The operation is performed with the patient in the lithotomic position under general anesthesia with the target controlled infusion technique.
The surgical technique is the one proposed by Antonio Longo and published by Renzi et al11 with some modifications. The intervention begins with anal dilation and introduction of the circular anal dilator (CAD), which is attached to the perianal region with 4 stitches (Fig. 1). The prolapsed tissue is then pulled out through the CAD by using a gauze pad and Allis forceps; this allows us to identify the extent of the prolapse to be resected (Fig. 2). Four to 5 parachute stitches are then apposed circumferentially, like parachute cords, at the apex of the prolapse, to control the tissue during resection (Fig. 3). The prolapse is then opened longitudinally at 3 o’clock with the electric scalpel between 2 Kocher clamps. Two traction stitches are applied at the deep vertex of the prolapse, one for each Kocher apex (Fig. 4). The longitudinal opening then allows the surgeon to begin circumferential resection of the rectum by pulling on the parachute stitches. This maneuver is performed counterclockwise with the use of an average of 4 to 6 recharges, with care to always place the stapler at the base of the prolapse (Fig. 5). At the end of the procedure, it is helpful to place some stitches on the staple line to control eventual anastomotic bleeding and at the beginning and end of the resection to avoid dog-ears (Fig. 6). The resected specimen was always inspected before the end of the procedure (Fig. 7).
Between June 2007 and February 2011, in our surgical division, we performed 206 consecutive STARR procedures with the use of CCS-30. Seventeen of these patients were excluded from the study, 13 because the indication for surgery was an important fourth degree hemorrhoidal prolapse in the absence of symptoms of ODS and 4 because they did not return for follow-up at 3, 6, and 9 months after surgery.
Thus, we evaluated 187 patients with a minimum follow-up greater than 1 year, 182 women and 5 men, with an average age of 56 years (range, 33–85 years) and a mean BMI of 25.7 kg/m2 (range, 21–33 kg/m2) (Table 1). Of these, 4 (2.1%) patients had already undergone stapled hemorrhoidectomy, 6 (3.1%) had undergone hemorrhoidectomy performed with the Milligan-Morgan technique, and 1 patient (0.5%) had been subjected to STARR 3 years before. Of the 182 women treated, 8 (4.3%) had undergone hysterectomy, 5 (2.7%) were nulliparous, 95 (52.3%) were multiparous, and 73 (40.1%) had undergone an episiotomy. The previous interventions are described in Table 2.
TABLE 1. Biographic data
TABLE 2. Previous intervention
After the preoperative evaluation with cinedefecography and anorectal manometry, 26 patients (25 women and 1 man) underwent a preoperative pelvic floor rehabilitation with 3 months of twice-weekly sessions of biofeedback combined with electrostimulation and kinesitherapy with Kegel exercises. Sixteen of them underwent preoperative pelvic floor rehabilitation because of hypocontinence/incontinence of the anal sphincter, 7 because of the presence of an abdominopelvic dyssynergia, and 3 because of a major increase in the threshold of rectal sensation.
All rehabilitated patients were reevaluated before surgery with anorectal manometry, which indicated the extent to which tone and coordination of the continence muscles had been recovered.
In 156 (83.4%) patients, cinedefecography revealed the presence of an anterior rectocele larger than 2 cm, whereas almost all patients (181/187) had rectorectal or rectal-anal intussusceptions.
Preoperative evaluation with CSS showed a mean value of 15.8 (± 4.9), whereas the evaluation at 6 months after surgery showed a statistically significant (p < 0.0001) decrease in the CSS value (5.2 ± 3.9). Considering the 151 (80.3%) patients who took laxatives before treatment, only 25 (13.2%) continued to take them afterward. Of those 49 (26.2%) who had used enemas to facilitate evacuation, only 7 patients (3.7%) continued to do so after surgery, and none of the 17 (9.1%) patients who were forced to help themselves with digitation needed to continue this practice 6 months after the procedure (see Table 3).
TABLE 3. Functional results
The mean operative time (from the beginning of perianal infiltration to the CAD removal) was 48 minutes (range, 32–78 minutes); all patients were discharged within 72 hours from the surgery, and none was readmitted for complications. The main complications are summarized in Tables 4 and 5. The average level of patient satisfaction at 6 months after surgery was 3.87, with a value of 4.18 if we consider the 86 patients with ODS for over 10 years.
TABLE 4. Surgical complication
TABLE 5. Functional complication
Obstructed defecation syndrome is a multifactorial disease related to the presence of anatomical and functional disorders, and its surgical treatment is directed to resolution of the anatomical obstruction.
The recent introduction of a new device, the Contour Transtar, has introduced a new technique with which to perform the STARR procedure.20–24 This stapler is very ergonomic because of its crescent-shaped and curved profile, allowing the surgeon to perform the transanal resection with direct visualization. Unlike the previous technique, which involved the use of 2 circular staplers, it is now possible for the surgeon to select the amount of tissue to be resected for each patient, without being limited by the capacity of the stapling case. It is then possible to perform a truly tailored surgery.20–24
The results of our experience confirm the validity of this technique regarding the reduction of obstructive symptoms as evaluated by CSS, with a statistically relevant reduction in postoperative values after 6 months to the intervention. These good results were also confirmed by the significant decrease in the use of evacuation aids, such as laxatives, enemas, and digitations, as a consequence of the improvement of defecation because of the resolution of the anatomical obstruction.
The recovery of good defecatory function is also demonstrated here by the high degree of patient satisfaction, which reflects the reduced discomfort associated with this type of surgical procedure.
The even better satisfaction in patients who had experienced ODS symptoms for more than 10 years seems to be related to the highly negative effect that these symptoms have on the quality of life. Indeed, the control of bodily functions is part of everyday life, and a deterioration of this area results in a poorer quality of life.
This study is limited in that it is a case series and therefore probably has the constraint of an observational bias. We have attempted to avoid this bias by including in the study all patients with a surgical indication for ODS. Also, the lack of a control group makes it difficult to draw definitive conclusions on the efficacy of this technique.
Another limitation concerns the relative short follow-up (1 year) for the patients studied that does not allow full assessment of the functional results of this technique and the detection of any possible recurrences. Long-term follow-up data are required to further evaluate the findings of this study.
A further limitation of this study is represented by the lack of use of a validated quality-of-life questionnaire, but, instead, the use of a simple satisfaction score. The satisfaction score is not a validated instrument but reflects in an rather accurate manner the quality of life after surgery for a functional disorder. In addition, in this study, the satisfaction questionnaire is completed during the follow-up office visit 6 months after the intervention and consequently expresses almost exclusively the improving of defecatory function and consequently also the quality of life.
In our hands, the use of the Contour stapler to perform stapled transanal resection of the rectum was safe and effective. The postoperative decrease of the CSS score in our series is slightly better than the ones reported in the literature.20–24 These good functional results are, therefore, not only related to the characteristics of the stapler but also to the management of the whole procedure starting with a complete and accurate preoperative study, continuing with an optimized surgical procedure, and concluding with a careful and effective management of postoperative complications.
The most common functional complications of this procedure in our experience are tenesmus and urgency, which are related to modification of the rectal ampulla anatomy and to the presence of an inflammatory reaction around the staple line.11,20–23 These complications are, however, almost all resolved within 3 months after surgery.
Gas or fecal incontinence are rare; 6 (3.2%) cases occurred in our series, but this was a serious complication, because gas or fecal incontinence also have psychological repercussions. To reduce the risk of postoperative incontinence, it is also important to evaluate with an anorectal manometry the presence of an anal sphincter contractile deficiency to identify those patients who may need preoperative pelvic floor rehabilitation treatment.15–17
In our series, all of the postoperatively incontinent patients were successfully treated with pelvic floor rehabilitation within 6 months, with the exception of 1 patient who required 15 months of treatment. These data are comparable to the data reported in literature.21–24
This study also showed the importance of accurately managing postoperative functional complications, which may improve the results of this technique. The use of pelvic floor rehabilitation to treat the fragmented evacuation as well as the removal of the retained staples may improve the postoperative discomfort experienced by the patient.25,26
Serious complications such as rectovaginal fistula, rectal perforation, bleeding, or visceral injury are rare but always feared.20–25 In our experience, we reported only 1 rectovaginal fistula, which occurred because of entrapment of the posterior vaginal wall between the branches of the stapler. This complication, which occurred in the initial phase of our learning curve, was treated by repairing the rectal wall with advancement flap and did not require the creation of a protective stoma. To prevent a repetition of this complication, we carefully check the posterior vaginal wall before firing the stapler.
The results of this preliminary experience have demonstrated the efficacy of the STARR with CCS-30 in treating ODS. The indication for the use of this surgical procedure is, of course, the presence of rectal prolapse with rectorectal or rectal-anal intussusception and/or an anterior rectocele. A greater number of cases organized in a prospective randomized multicenter study is needed to confirm these findings. This study also revealed the need for a preoperative study that includes cinedefecography and anorectal manometry to correctly evaluate the indications presented and reduce the risk of long-term complications such as incontinence. The technical challenges of this procedure and the management of complications as well as the execution of a preoperative study require specific skills. This type of intervention should therefore be undertaken by an experienced and dedicated team.