Any communication between the rectum/anus and the vagina/perineal skin is classically referred to as a rectovaginal fistula (RVF). RVF is an accepted term for any fistula that originates in the distal rectum and anus and is connected to the vagina, perineal body, or labial area, because the evaluation and treatment are similar. In contrast, a fistula between the colon and vagina (such as may occur after a hysterectomy when the sigmoid communicates with the top of the vagina) is a completely different problem and will not be discussed in this chapter.
An obstetrical injury is the most common cause of RVF. Other common causes are cryptoglandular sepsis, Crohn disease, cancer, radiation therapy, and trauma (e.g., after excision of a mass in the rectovaginal septum). Identifying the source of the fistula is critical because it may alter the evaluation and treatment plan.
History and Physical Examination
Obtaining an accurate history is important, beginning with an exact description of symptoms. Passage of gas, stool, or purulent fluid and the presence of dyspareunia, perineal pain, vaginal irritation, and recurrent urinary tract infections should be noted. The patient should describe her bowel habits both before and after the symptoms started, including a complete description of fecal incontinence. The effect of the symptoms on daily life is important. Other factors that affect bowel habits such as chronic diseases (e.g., diabetes, lupus) and all medications should be reviewed. The patient’s radiation, pelvic/anal surgery, and obstetrical history is noted, and in preparation for surgery, a full medical and surgical history is obtained and a review of systems is performed. Box 6-1 outlines specific areas to be covered.
Symptoms (e.g., gas, stool, and drainage of purulent fluid from the vagina)
Recurrent urinary tract infections
Past pelvic and anal surgery (including obstetrical history and any prior pelvic irradiation)
Chronic diseases and medications that affect bowel habits
During the physical examination, the abdomen is evaluated for body habitus, scars, hernias, and masses. Any debris at the vaginal introitus should be noted at the beginning of the perineal examination. Particular attention is directed to the status of the anus (i.e., closed or open), the width of the perineal body, and the movement of the anal muscle when the patient is asked to strain and squeeze. A more detailed evaluation of the vagina is performed next; one should look for the actual vaginal opening, the presence of stool in the vagina, and any prolapse of the vaginal wall with straining. The rectovaginal septum is critically appraised with a finger in the anus and a finger in the vagina, feeling for induration or a sense of fullness. During the digital anal examination, the anal tone at rest and while squeezing along with early fatigue (i.e., reduced strength of anal contractions during several repetitive squeezes) is assessed. Recruitment of buttock muscles when the patient is asked to squeeze versus levator contraction versus actual anal muscle contraction is noted, along with the presence of masses, stool in the rectum, and induration (particularly anteriorly). At times the internal opening of the fistula can actually be felt during the digital examination. The shape of the upper medial thighs should be noted because gas or stool can escape the anus and pass forward into the vagina, later to be expelled, suggesting a fistula. In such cases the patient does not have a fistula, of course, and instruction in the management of anal incontinence is provided. Patients with loose upper thighs are prone to this phenomenon because the anatomy directs the seeping material forward toward the vagina.
The next step is anoscopy and proctoscopy (either flexible or rigid) to seek the internal opening of the fistula and to note the condition of the rectal and anal mucosa. Noting the presence of anal or distal rectal ulceration at the internal opening is important because repair is avoided when inflammation is present. Sometimes rigid or flexible endoscopy of the vagina provides valuable information regarding the size and location of the fistula and assists in visualizing debris in the vagina. If the completeness of the examination is in question, an examination is performed after the induction of anesthesia to fully delineate the size and location of the fistula. Another benefit of performing an examination after the patient has been anesthetized is that it provides the opportunity to drain any trapped sepsis by unroofing a cavity or placing a draining seton. Before any repair can be entertained, all sepsis must be eliminated so the tissue is as soft and supple as possible. If the cause of the fistula is related to cancer, liberal biopsies of the area are performed to rule out recurrence.
Other testing depends on findings uncovered during the history and physical examination. Any women older than 50 years should have a colonoscopy. Other indications for a colonoscopy include a history of loose stool, the possibility of Crohn disease, or a change in stool habits. Areas of inflamed mucosa or other lesions are biopsied. Additionally, random biopsies are performed in women with diarrhea to rule out microscopic colitis. Diarrhea and irritable bowel–type symptoms may warrant a consultation with a gastroenterologist. Bowel habits should be optimized prior to plans for surgical repair of the fistula. Also, if Crohn disease is proven or suspected, a complete bowel evaluation is beneficial because medical therapy or surgery may be included in the treatment algorithm.
The role of anal physiology testing in the workup of a patient with an RVF is debated. Such testing should only be performed if the caregiver believes it would alter the treatment approach. In contrast, anal endosonography is overall probably the most beneficial test because it provides full details regarding sphincter integrity, which influences the choice of surgical procedure.
After all data are gathered, treatment is proposed. When discussing treatment with the patient, realistic goals should be elucidated. Surgery may not be the best option for women with a small internal opening and minimal symptoms. It is important to remember that surgery could make the situation and symptoms worse, as well as create additional scarring. If Crohn disease is present, it should be treated or managed surgically before embarking on a surgical course to close the fistula. Additionally, diarrhea should be under optimal control. Occasionally a diverting stoma (typically an ileostomy) is required for the tissue to become supple enough to perform a repair, particularly when the fistula is related to radiation. Hyperbaric oxygen treatment may improve radiated or scarred tissue to a sufficient degree to permit a repair to be attempted. Use of a vaginal hormone cream for a month before performing a repair also may improve the elasticity of tissues in postmenopausal women.
Options for treatment ( Box 6-2 ) are classified as medical, nonsurgical closure, or surgical closure. The route for closure is accomplished via the vagina, perineum, anus, or abdomen or through a combination of these approaches.
Treat Crohn disease when present
Rectal advancement flap
Advancement sleeve flap (may also include a transabdominal approach along with the transanal approach; if the transabdominal approach is used, the patient may need a delayed coloanal anastomosis [Turnbull-Cutait procedure])
Ligation of the intersphincteric fistula tract
Interposition of tissue
+ Gracilis muscle
+ Martius flap
For some patients, management of diarrhea will improve the situation to the extent that the risks of surgery and of making the hole larger outweigh the symptoms. Some methods of treating diarrhea include titration of insoluble fiber and loperamide. Biopsy findings that are positive for collagenous or microcytic colitis warrant appropriate medical treatment, which is outside of the scope of this chapter.
Medical treatment, including antibiotics and biologic therapy for an RVF related to Crohn disease, will sometimes lead to closure of the fistula. More commonly, the fistula is situated at the base of an ulcer. Medical treatment may change the quality of the anal canal from an inflamed ulcer to a dry scar, which in turn may permit closure to be considered.
Failure of a fistula plug carries minimal risk. Dislodgement of the plug can be an early cause of failure, and thus when a plug is used to treat an RVF, it is modified through the addition of a button that is sewn into the mucosa and submucosa on the anal side. This button stabilizes the plug to reduce chances of dislodgement. A short or epithelialized tract is not ideal for a plug closure. In the operating room, the tract is lightly debrided with gauze or a brush and then flushed with hydrogen peroxide. The size of the plug is chosen based on the fistula size, and the plug is prepared according to the manufacturer’s specifications. The tapered end of the plug is pulled from the anal side to the vaginal side so that the button rests against the anorectal wall. The plug is stabilized with a 2-0 polyglycolic acid suture placed deeply through the anal tissue, the plug, and the button holes. The button should remain flat against the rectoanal wall after the sutures are placed. Excess plug material is trimmed from the vaginal side. Adequate space between the plug and the external opening is necessary to allow for drainage. Postoperatively, for about 4 weeks, the patient is advised to avoid strenuous activity and lifting more than 20 pounds. Additionally, sexual intercourse, baths, swimming, and soaking of the anal area are to be avoided for 4 weeks, although showers are permitted. After defecation, wet toilet paper can be used, but use of wipes containing chemicals should be avoided. Drainage and spotting of blood are expected, but upon detection of anything more extensive, patients are advised to call their doctor. Mineral oil or other stool softeners are used to prevent patients from straining to defecate. Use of antibiotics is controversial; however, in my unit we prescribe oral ciprofloxacin for 7 days and application of metronidazole cream to the external opening twice daily for 7 days.
Instillation of fibrin glue into the tract has been described to close an anal fistula. This option typically is not favored because RVF tracts are usually short and, overall, results are dismal when fibrin glue is used with any type of anal fistula. However, the risks of this treatment are low. Use of fibrin glue under a flap repair has also been entertained, but few positive data regarding this approach have been reported.
Rectal Advancement Flap
The integrity of the anal sphincter is probably one of the most important aspects to consider when contemplating the choice of surgical repair. If the sphincter is intact and the fistula is above the dentate line, an advancement rectal flap procedure can be peformed. Although this repair can be performed in any position, the prone jackknife position provides optimal exposure. I prefer full bowel preparation, use of intravenous (IV) antibiotics, and having a Foley catheter in place during the procedure. Unless the tract is completely dry and epithelialized, I also prefer that a draining seton be in place for a month prior to closure, which facilitates elimination of any sepsis or entrapped fluid in the tract and improves the pliability of the tissues.
The flap starts a few millimeters distal to the internal opening, and the arc for the flap is about 180 degrees. The anal canal mucosa is carefully removed, avoiding injury to the internal anal sphincter. The flap then becomes full thickness of rectum cephalad to the anal sphincter complex. Mobilization of the rectum from the rectovaginal septum continues until the distal end can be advanced without tension to the opposite cut edge on the distal anal canal. The fistula is cored out and closed in layers with figure-of-8, 3-0 polyglycolic acid sutures. The internal opening is closed from the anal side only. The use of a UR 5–type needle facilitates the ability to obtain a deep suture in the confined space of the anal canal to close the opening. Usually the closure is performed from cephalad to caudad in several layers using figure-of-8 sutures. The vaginal or perineal side will be left open, and sometimes the external opening is enlarged to ensure adequate drainage. The distal tip of the flap, which includes the area of the internal opening, is trimmed. The goal is to advance full-thickness rectum distally. To reduce tension at the suture line, one or two simple sutures may be incorporated beneath the flap. One bite (not full thickness) is placed through the tissue on the undersurface and the other is placed through the distal cut edge in the anal canal. Then, after ensuring hemostasis, the flap is advanced to the distal cut edge and sewn in place with 3-0 polyglycolic acid sutures. The middle sutures are placed first with deep, simple, full-thickness bites. Sewing is then carried laterally on each side to complete the suture line. Some variations in flap construction include short bursts of running suture to close the two edges, minimal mobilization of the flap with more of a layered closure, and orientation of the flap longitudinally (instead of the semicircle).
Postoperatively, in patients without a diverting stoma, restricting oral intake for 2 to 3 days may delay passage of stool over the fresh sutures. The perineal area is examined on postoperative day 1 to assess for swelling and bruising. If significant swelling or bruising is present, a delay in the removal of the Foley catheter until postoperative day 2 is considered. Although preoperative administration of antibiotics is universal, considerable variation exists regarding the postoperative use of antibiotics, from none to 7 days. I favor administration of IV antibiotics while the patient is in the hospital and then completion of a total 5- to 7-day course of oral antibiotics. There is also no consensus regarding activity limitations. Although some surgeons curtail activity and prescribe bed rest for postoperative days 1 to 2 in order to avoid pulling on the suture line, I allow patients to be out of bed but ask them to avoid sitting as much as possible. No scientific evidence exists for any of these activity restrictions.
Care after hospital discharge sometimes can be more important than the postoperative care provided in the hospital in facilitating success. Patients are encouraged to walk and go up steps but to lift no more than the weight of a gallon of milk. They can sit on a pillow but not on a doughnut, which spreads the buttocks and pulls on the perineal skin. If they do not have a proximal stoma, I ask them to ingest an ounce of mineral oil daily along with insoluble fiber. While they are in the hospital, I do not allow them to eat until the day of discharge. On the day of their discharge they are given a solid diet, their first dose of mineral oil, and the oral antibiotic. If they do not have a stool by 2 to 3 days after discharge from the hospital, I ask them to ingest an ounce of milk of magnesia daily until they have a bowel movement. Patients are in regular phone contact with my nurse to ensure that constipation is avoided. I also allow patients to take showers but instruct them to avoid taking baths for 2 to 3 weeks because a bath seems to make the anal skin waterlogged.
The nurse continues to be in regular phone contact with the patient, and any concerns regarding pain or pressure are immediately addressed, usually at an office visit. At times, performing an examination with use of an anesthetic is necessary to investigate the source of the pain and verify the absence of trapped fluid. On several occasions, making a counter incision to allow drainage lateral to the flap has prevented the flap from being lifted off when patients presented with new pain or pressure.
Successful closure of an RVF with a rectal advancement flap can be expected in about 65% of women. Smoking and Crohn disease have been associated with failure of this procedure.
Advancement Sleeve Flap
In some women, significant scarring in the anal canal or anal canal stenosis precludes use of an advancement rectal flap. In these situations, use of an advancement sleeve flap is considered. The perioperative preparation is the same as for the advancement rectal flap. The procedure differs in that a full circle of anal canal mucosa is excised, starting anteriorly a few millimeters distal to the internal opening. The incisional line for the posterior half of the sleeve is the dentate line. The mucosectomy is continued cephalad to the top of the anal sphincter; the dissection is then carried laterally so that a full thickness of rectum is mobilized. The plane that is entered is the same one utilized when performing an Altemeier procedure (i.e., a perineal proctosigmoidectomy). However, when performing the Altemeier procedure, the plane is typically a little more redundant and stretched out from the prolapse. Mobilization continues cephalad until the sleeve will advance to the neodentate line without tension. Closure of the internal opening is performed in the same manner as for the rectal advancement flap. Because of the possibility that fluid may become trapped beneath the flap, I insert a 10-mm drain that lies beneath the flap, comes out the buttock laterally (inserted using a trocar), and connects to a red-top test tube or bulb to exert negative pressure. I am amazed at the amount of serous fluid that is collected during the first 2 to 3 days—sometimes as much as 20 mL daily. I remove the drain when the output is about 5 mL in a 24-hour period. The anterior proximal edge of the flap is trimmed and the flap is advanced down and sewn to the neodentate line as outlined for the advancement rectal flap. Because mobilization for a sleeve flap is more extensive, a diverting stoma is typically placed. Otherwise, the postoperative care is the same as that previously outlined for the advancement rectal flap.
A sleeve is useful in persons with Crohn disease because significant anal canal scarring and tissue fixation may be present. The mucosectomy removes the scarred anal canal tissue, and provided the rectum has little to no inflammation, healthy tissue can be brought into the area. The success rate of the sleeve is about 65%, with similar results for Crohn and non-Crohn etiologies.
In some cases the circumferential rectal flap will not reach the neodentate line. When this situation is encountered, the patient will need to be turned onto her back and placed in stirrups, and an abdominal approach is added to gain sufficient length. This procedure entails mobilizing the rectum circumferentially. I try to avoid dividing the inferior mesentery artery and vein until I am sure it is needed for sufficient mobilization and reach. However, I do not hesitate to divide the artery and vein or mobilize the splenic flexure to augment length and avoid tension on the anastomosis. When the abdominal approach is added, an ileostomy is almost always performed.
A Turnbull-Cutait staged colo-anal anastomosis, which is a variation of the abdominal mobilization of the rectum, may improve chances of successful closure of the fistula. The difference is that maturation of the anastomosis is delayed for 5 to 7 days as opposed to suturing it at the initial operation. This approach allows two raw surfaces to seal before sutures are placed through the bowel. This approach may be favored when the internal os will be close to the suture line.
After the mucosectomy, abdominal rectal mobilization, and closure of internal os are performed, eight sutures of 3-0 polyglycolic acid are placed in the cardinal positions around the anus. These sutures are placed with deep bites from the outside of the anoderm to the inside of the raw cut surface and pinned out radially to avoid tangling. The healthy bleeding cut edge of the distal bowel (usually rectum) is then brought out the anus and positioned so the bowel is extruded 5 to 10 cm from the anal verge. The bowel is wrapped with petroleum jelly (e.g., Vaseline)-impregnated gauze. Next, the sutures are unpinned and wrapped around the (now Vaseline covered) extruded bowel, and all is held in place via wrapping with Kerlix gauze, which is stabilized with clips or simple sutures. When this approach is used, an ileostomy is always performed.
The patient recovers on the nursing floor and is able to walk and sit. The only caveat is that most women retain their Foley catheter until after stage 2. After 5 to 7 days, the patient is returned to the operating room and placed in the lithotomy position, the gauze is carefully unwrapped, and the sutures are pinned out radially around the anus. By this time the serosa of the bowel has adhered to the raw surface created in the anal canal. Great care is taken to avoid disrupting this attachment. The bowel is amputated at least 1 cm distal to the anal opening, and the sutures are placed through the cut edge of the bowel and tied. I prefer to add short bursts of running suture to further stabilize and seal the anastomosis. When the anastomosis is completed, a small amount of ectropion exists that typically will retract into the anal canal within 6 months. Amputating the bowel more proximally increases the risk of disrupting the seal between the bowel and the anal canal.
Before closing the stoma, I routinely examine the anesthetized patient to ensure the fistula is closed and everything has healed.
When the transvaginal approach is used, with the patient in the lithotomy position, the posterior vaginal mucosa is mobilized starting distal to the fistula opening and extending several centimeters proximally. Although most reports indicate that a semicircular vaginal flap is utilized, some surgeons use a linear flap. The tract is excised and closed in layers with 3-0 absorbable suture. Some reports emphasize the use of several layers of pursestring sutures for closure, whereas other reports indicate that closure is performed with figure-of-8 sutures. Care is taken to avoid shortening the vagina or creating an uneven surface along the posterior vaginal wall because each consequence can contribute to dyspareunia.
One reported advantage of this approach in persons with Crohn disease, especially if some element of inflammation is present, is that the anal area is undisturbed.
Ligation of the Intersphincteric Fistula Tract
If the tract is in the upper anal sphincter region, then a ligation of the intersphincteric fistula tract can be performed. This technique does not divide any anal muscle, and data are accumulating regarding the results for closure with this approach. (A more detailed description of this approach for non-RVF anal fistula can be found in Chapter 5 ).
When a woman who had a previous vaginal delivery has an anterior sphincter defect (no matter the cause of the RVF), an episioproctotomy is recommended. It is important to remember that the patient can have a wide intact perineal body but a weak, deficient, or scarred sphincter. Therefore, unless the sphincter is clearly defective, an anal ultrasound is invaluable in detecting an anal sphincter defect.
The preparation is the same as for the advancement rectal flap. With the patient in the prone position, a probe is placed through the fistula tract and an incision is made over the probe. Sometimes the length of skin that will be divided is daunting, but remembering that no or minimal muscle will be divided is key. The muscle ends are dissected out and the internal and external sphincter muscles that have been joined by scarring are left in place. Some dissection is required in the rectovaginal septum to debride the epithelialized fistula tract and allow the sphincter repair space to lie flat after sutures are tied. The sphincter is totally debrided, and hemostasis is ensured. Crossing the sphincter over in a vest-over-pants type fashion (i.e., left over right versus right over left) will allow visualization of the optimal setup for repair. The goals are for the overlapped muscle repair to lie flat and as much dead space as possible to be obliterated. After determination of the optimal overlap, attention is turned to the rectal mucosa, which is closed first. Starting at the cephalad aspect, far-far-near-near 2-0 or 3-0 polyglycolic acid sutures are placed in the rectal mucosa. The aim is precise approximation of the mucosa. These sutures are placed until about the level of the dentate line and tied down. It is important to place these sutures first because visualization will be decreased after the muscle overlap, making precise placement impossible. Next, using 2-0 polydioxanone sutures, a vest-over-pants type repair is performed to overlap the muscle; then the free edge of muscle from the overlap can be tacked down with 2-0 polydioxanone suture. The rectal mucosa is then closed to the level of the perineal skin, stopping at about the anal verge. Next, the apex of the vaginal defect is closed with mattress sutures of 2-0 polyglycolic acid. Depending on the amount of dead space, I will loosely approximate the vaginal closure, because if fluid has accumulated, I want it to drain out the vaginal side rather than the anal side. Care is taken to line up the hymenal ring during the vaginal closure. The perineal skin from the introitus to the anal verge is also usually (but not always, depending on the amount of dead space) left open for drainage.
Postoperative care is similar to that for the rectal sleeve flap. This approach does not require a diverting stoma, although if the repair is a repeat procedure or if it is unusually complex, use of a stoma may be considered. Careful postoperative monitoring is key to improving success. Any reports of pressure or increased pain or concerns about fluid accumulation require an examination after induction of anesthesia to drain trapped fluid and prevent it from coming out the anorectal suture line. On many occasions, a local physician has prescribed antibiotics for these symptoms, and when I finally see the patient, she will report that fluid or drainage came from the anus, which relieved her symptoms but was associated with recurrent RVF symptoms. Preventing drainage of this fluid from the anorectal suture line may help avoid a recurrence.
If a stoma has been placed, about 2 to 3 months later I examine the anesthetized patient prior to closing the stoma. Any granulation tissue found along any suture line raises suspicion for a persistent fistula and mandates a very careful examination.
With this approach, closure of the fistula has been reported in nearly 80% of cases when the cause was obstetrical or cryptoglandular.
Placement of muscle (typically the gracilis) between the rectum and vagina via a transperineal approach is an option when the patient has a lot of scarring in the anal canal and the goal is to bring in healthy tissue with a good blood supply. For this procedure I team up with a plastic surgeon, who mobilizes the gracilis. I prefer that the patient be positioned in the prone jackknife position to allow precise dissection in the rectovaginal plane. The plastic surgeons I have worked with have adapted and can mobilize the muscle in the prone position, but I ensure they are present for the positioning, prepping, and draping. One must be sure the tunnel from the leg to the space in the rectovaginal septum is wide and does not impinge on the muscle or its blood supply. In the rectovaginal septal mobilization, a wide transverse incision is made over the perineal body between the anus and vagina. This mobilization is carried at least 2 to 3 cm cephalad to the fistula tract. The anal and vaginal openings are closed from inside the rectovaginal septum with 2-0 or 3-0 polyglycolic acid mattress sutures. Sutures are next placed cephalad to the opening on the rectal side but are not tied, usually at each corner of the space that results from the transverse mobilization. Then the gracilis muscle is brought through the groin tunnel and oriented so the flat surface of the muscle lies flat against the rectum and the previously placed sutures are brought through the muscle and tied. Other sutures are placed around the repaired rectal hole and tied down, always maintaining a flat surface of the muscle that is sitting against the rectum. If the muscle has a lot of bulk, the remaining muscle is secured with sutures. The perineal skin may be left open or loosely approximated with absorbable sutures. Because it is important to prevent fluid accumulation, a Penrose drain is positioned along the muscle on the vaginal side to promote fluid drainage. A stoma is almost always used.
Postoperative care and restrictions are usually dictated by the leg incision (i.e., they are determined by the plastic surgeon). There is usually a drain in the donor muscle bed along the medial surface of the thigh. Typically, the patient is instructed to avoid lifting and strenuous activity for 4 weeks. Showers are permitted, but baths and swimming should be avoided until granulation tissue forms over and seals all suture lines.
Gracilis interposition is typically reserved for cases in which multiple previous attempts to repair the fistula have failed and for fistulas that are radiation induced or related to cancer excision. Success rates of 60% to 75% have been reported.
The Martius flap is another procedure that brings healthy tissue into the area. The patient is usually in the lithotomy position during the procedure. A vertical incision is made over the labia majora to expose the bulbocavernosus fat pad beneath. Mobilization begins from the lateral aspect of each side of the incision working medially. The fat pad is mobilized off the fascia covering the urogenital diaphragm posteriorly and the labia minora and bulbocavernosus muscle medially. The lateral blood supply is sacrificed. After the tube of fatty tissue is circularly mobilized, dissection is carried cephalad and superiorly (away from the perineum), and the vessels and blood supply are divided. Hence the blood supply for this fibrofatty flap is from the perineal branches of the internal pudendal artery that remains attached at the most inferior aspect. A generous tunnel is made in the subcutaneous tissue to carefully deliver the bulky fat pad into the wound. Orientation must be assessed to ensure it is not twisted, which could reduce blood flow and lead to ischemia. The Martius graft can be used to augment a sphincter overlap, or in place of the gracilis, and is placed in the rectovaginal septum to separate the anorectal and vaginal openings. A Penrose drain is placed in the labia, and the area of the donor site is closed in layers with absorbable sutures. The labial skin is then closed. Optimally when using this approach, the bulk of the fat pad will reach to completely cover the repaired opening. However, this can be a limitation because some women have small, thin labial fat pads. The skin over the perineal area is closed as described for the gracilis interposition.
Dissection in the rectovaginal plane and closure of the openings at the anal and vaginal side, followed by placement of a biologic material, has been reported. Loose or no approximation of the perineal skin at closure is recommended because significant drainage occurs that can last for several weeks. Although some surgeons are enthusiastic about this procedure, I have not embraced it because afterward the tissue takes on a cardboard-like nature, and if the procedure fails, any further repair is then hampered by the inflexibility of the tissue.